osur-20260630

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

______________________________________

FORM 10-Q

______________________________________

(Mark One)


x			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2026.


o			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _________to _________ .

Commission File Number 001-16537

______________________________________

ORASURE TECHNOLOGIES, INC.

(Exact Name of Registrant as Specified in Its Charter)

______________________________________


Delaware			36-4370966
(State or Other Jurisdiction of Incorporation or Organization)			(IRS Employer Identification No.)


220 East First Street, Bethlehem, Pennsylvania			18015
(Address of Principal Executive Offices)			(Zip code)

Registrant’s telephone number, including area code: (610) 882-1820

______________________________________

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading
Symbol(s)

Name of each exchange on which registered

Common Stock, $0.000001 par value per share

OSUR

The Nasdaq Stock Market LLC

Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes x No o

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Indicate by checkmark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

As of July 31, 2026, the registrant had 68,968,627 shares of common stock, $0.000001 par value per share, outstanding.

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains certain “forward-looking statements” within the meaning of the Federal securities laws. These may include statements about the Company's expected revenues, earnings/losses per share, net income (loss), expenses, cash flow or other financial performance, or developments, clinical trial or development activities, expected regulatory filings and approvals, planned business transactions, views of future industry, competitive or market conditions, and other factors that could affect the Company's future operations, results of operations or financial position. These statements often include words such as “believes,” “expects,” “anticipates,” “intends,” “plans,” “estimates,” “may,” “will,” “should,” “could,” or similar expressions.

Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to:

•Market acceptance of, and the Company's ability to develop, commercialize, market and sell, its products and services, whether through its internal direct sales force, distributors or third parties;

•The Company's ability to obtain and comply with necessary regulatory approvals for new products or new indications or applications for existing products, including timing and associated costs;

•Failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for the Company's products;

•Significant customer concentrations that exist or may develop in the future;

•The Company's ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements;

•Changes in relationships with strategic partners or other parties, including disputes or disagreements and reliance on such parties for the performance of critical activities under collaborative arrangements;

•The Company's ability to meet increased demand for its products;

•The impact of replacing distributors on the Company's business;

•The Company's ability to achieve its financial and strategic objectives, including increasing its revenues and gross margins, and its ability to expand international sales;

•The impact of competitors, competing products and technology changes on the Company's business;

•Reduction or deferral of public funding available to customers;

•Changes in market acceptance of the Company's products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention (the "CDC") or other agencies;

•The Company's ability to fund research and development and other products and operations;

•The availability of raw materials and the Company's reliance on sole supply sources for critical products and components;

•The impact of contracting with the U.S. government on the Company's business;

•The Company's estimates regarding revenues, expenses, capital requirements and needs for additional financing, and the availability and cost of financing;

•The ability to utilize net operating loss carryforwards or other deferred tax assets;

•Volatility of the Company's stock price;

•Uncertainty relating to patent protection, potential patent infringement claims, the availability of licenses to patents or other technology;

•Costs of litigation relating to intellectual property, product liability and other types of litigation;

•The impact of changes in international funding sources and testing algorithms on international sales;

•Adverse movements in foreign currency exchange rates;

•The Company's ability to attract and retain qualified personnel;

•Changes in international, federal or state laws and regulations; and

•The impact of geopolitical and economic conditions on the Company's business.

These and other factors that could affect the Company's results are discussed more fully under the section titled “Risk Factors,” set forth in Part II, Item 1A of this Quarterly Report on Form 10-Q, if any, in Part I, Item 1A of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed with the Securities and Exchange Commission (the “SEC”) on March 9, 2026, and in subsequent SEC filings. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this report and the Company undertakes no duty to update these statements, unless it is required to do so by law. If the Company does update one or more forward-looking statements, no inference should be drawn that it will make updates with respect to other forward-looking statements or that it will make any further updates to those forward-looking statements at any future time.

Investors should also be aware that while the Company does, from time to time, communicate with securities analysts, it is against the Company's policy to disclose any material non-public information or other confidential commercial information. Accordingly, stockholders should not assume that the Company agrees with any statement or report issued by any analyst irrespective of the content of the statement or report. Furthermore, the Company has a policy against issuing or confirming financial forecasts or projections issued by others. Thus, to the extent that reports issued by securities analysts contain any projections, forecasts or opinions, such reports are not the responsibility of OraSure.


PART I. FINANCIAL INFORMATION

			Page No.

Item 1. Financial Statements (Unaudited)			3

Consolidated Balance Sheets at June 30 , 2026 and December 31, 2025			3

Consolidated Statements of Operations for the Three and Six Months Ended June 30 , 2026 and 2025			4

Consolidated Statements of Comprehensive Income (Loss ) for the Three and Six Months Ended June 30 , 2026 and 2025			5

Consolidated Statements of Cash Flows for the Six Months Ended June 30 , 2026 and 2025			6

Notes to the Consolidated Financial Statements			7

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations			23

Item 3. Quantitative and Qualitative Disclosures About Market Risk			30

Item 4. Controls and Procedures			30

PART II. OTHER INFORMATION

Item 1. Legal Proceedings			30

Item 1A. Risk Factors			31

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			31

Item 3. Defaults Upon Senior Securities			31

Item 4. Mine Safety Disclosures			31

Item 5. Other Information			31

Item 6. Exhibits			32

Signatures			33

Item 1. FINANCIAL STATEMENTS

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(Unaudited)

(in thousands, except per share amounts)


	June 30, 2026		December 31, 2025
ASSETS
Current Assets:
Cash and cash equivalents	$	160,582	$	199,278

Accounts receivable, net of allowance for doubtful accounts of $445 and $188	25,597		22,203
Inventories	30,071		31,060
Prepaid expenses	3,369		5,221
Income tax receivable	1,764		—
Other current assets	1,554		4,146
Total current assets	222,937		261,908
Noncurrent Assets:
Property, plant and equipment, net of accumulated depreciation	38,577		39,179
Operating right-of-use assets, net	11,090		11,996
Finance right-of-use assets, net	181		146
Intangible assets, net of accumulated amortization of $26,627 and $27,180	18,835		19,046
Goodwill	42,717		43,363
Investment in equity method investee	24,355		25,956
Deferred tax asset	450		271
Other noncurrent assets	1,410		1,303
Total noncurrent assets	137,615		141,260
TOTAL ASSETS	$	360,552	$	403,168
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable	$	8,401	$	6,521
Deferred revenue	851		1,518

Accrued expenses and other current liabilities	13,718		11,149
Finance lease liability	84		63
Operating lease liability	2,065		2,164
Acquisition-related contingent consideration obligation	—		18,380
Total current liabilities	25,119		39,795
Noncurrent Liabilities:
Finance lease liability	122		100
Operating lease liability	9,823		10,870
Acquisition-related contingent consideration obligation	5,233		9,333
Other noncurrent liabilities	2,478		2,243

Total noncurrent liabilities	17,656		22,546
TOTAL LIABILITIES	42,775		62,341
Commitments and contingencies (Note 12)
STOCKHOLDERS' EQUITY
Preferred stock, par value $0.000001, 25,000 shares authorized, none issued	—		—
Common stock, par value $0.000001, 120,000 shares authorized, 68,968 and 70,391 shares issued and outstanding	—		—
Additional paid-in capital	527,964		531,393
Accumulated other comprehensive loss	(21,897)		(18,404)
Accumulated deficit	(188,290)		(172,162)
Total stockholders' equity	317,777		340,827
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$	360,552	$	403,168

See accompanying notes to the consolidated financial statements.

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(in thousands, except per share amounts)


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2026		2025		2026		2025
NET REVENUES:
Products and services	$	29,724	$	29,847	$	56,100	$	58,844
Other	915		1,395		2,464		2,329
	30,639		31,242		58,564		61,173
COST OF PRODUCTS AND SERVICES SOLD	17,322		18,083		33,443		35,715
Gross profit	13,317		13,159		25,121		25,458
OPERATING EXPENSES:
Research and development	9,437		11,401		23,091		21,004
Sales and marketing	6,604		6,375		13,374		13,234
General and administrative	14,429		12,676		28,985		26,778

Change in the estimated fair value of acquisition-related contingent consideration	(22,573)		733		(22,480)		1,211
Gain on sale of assets	(20)		—		(20)		(993)
	7,877		31,185		42,950		61,234
Operating income (loss)	5,440		(18,026)		(17,829)		(35,776)
OTHER INCOME	1,377		1,135		2,925		2,913
Income (loss) before income taxes and equity investment	6,817		(16,891)		(14,904)		(32,863)
INCOME TAX EXPENSE (BENEFIT)	55		2,000		(377)		1,544
INCOME (LOSS) BEFORE EQUITY INVESTMENT	6,762		(18,891)		(14,527)		(34,407)
LOSS ON EQUITY INVESTMENT	(513)		(802)		(1,601)		(1,326)
NET INCOME (LOSS)	$	6,249	$	(19,693)	$	(16,128)	$	(35,733)

EARNINGS (LOSS) PER SHARE
BASIC	$	0.09	$	(0.26)	$	(0.23)	$	(0.48)
DILUTED	$	0.09	$	(0.26)	$	(0.23)	$	(0.48)
SHARES USED IN COMPUTING EARNINGS (LOSS) PER SHARE:
BASIC	69,003		74,541		69,337		74,703
DILUTED	70,158		74,541		69,337		74,703

See accompanying notes to the consolidated financial statements.

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(Unaudited)

(in thousands)


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2026		2025		2026		2025
NET INCOME (LOSS)	$	6,249	$	(19,693)	$	(16,128)	$	(35,733)
OTHER COMPREHENSIVE (LOSS) INCOME
Currency translation adjustments	(1,860)		6,751		(3,493)		6,989

COMPREHENSIVE INCOME (LOSS)	$	4,389	$	(12,942)	$	(19,621)	$	(28,744)

See accompanying notes to the consolidated financial statements.

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)

(in thousands)


	For the Six Months Ended June 30,
	2026		2025
OPERATING ACTIVITIES:
Net loss	$	(16,128)	$	(35,733)
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation	5,055		5,852
Depreciation and amortization	4,712		5,334

Other non-cash amortization	(172)		(147)
Provision for credit losses	288		(296)
Unrealized foreign currency loss	285		470
Interest expense on finance leases	6		4
Loss on equity investment	1,601		1,326
Deferred income taxes	(152)		(820)
Gain on sale of fixed assets	(20)		(780)
Change in the estimated fair value of acquisition-related contingent consideration	(22,480)		1,211

Changes in assets and liabilities:
Accounts receivable	(3,710)		(1,563)
Inventories	890		1,009
Prepaid expenses and other assets	2,478		(683)
Accounts payable	1,314		(1,548)
Deferred revenue	(663)		(520)
Accrued expenses and other liabilities	2,880		(3,072)
Net cash used in operating activities	(23,816)		(29,956)
INVESTING ACTIVITIES:



Proceeds from sale of assets	20		790
Purchases of property and equipment	(3,341)		(2,356)



Net cash used in investing activities	(3,321)		(1,566)
FINANCING ACTIVITIES:
Cash payments for lease liabilities	(45)		(26)

Repurchase of common stock	(7,000)		(5,000)

Payment of taxes related to net share settlement of equity awards	(1,484)		(1,725)
Net cash used in financing activities	(8,529)		(6,751)
EFFECT OF FOREIGN EXCHANGE RATE CHANGES ON CASH	(3,030)		5,088
NET DECREASE IN CASH AND CASH EQUIVALENTS	(38,696)		(33,185)
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD	199,278		267,763
CASH AND CASH EQUIVALENTS, END OF PERIOD	$	160,582	$	234,578
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
(Refund received) cash paid for income taxes	$	(44)	$	2,579
Non-cash investing and financing activities
Accrued property and equipment purchases	$	1,062	$	182

See accompanying notes to the consolidated financial statements.

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

(all tabular amounts in thousands)

1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:

Principles of Consolidation and Basis of Presentation

The accompanying interim unaudited consolidated financial statements include the accounts of OraSure Technologies, Inc. (“OraSure”) and its wholly-owned subsidiaries, DNA Genotek Inc. (“DNAG”), Diversigen, Inc. (“Diversigen”), Sherlock Biosciences, Inc. and its wholly-owned subsidiary Sense Biodetection Limited (collectively, "Sherlock"), and BioMedomics, Inc. ("BioMedomics"). Novosanis NV ("Novosanis") was a subsidiary of OraSure until it was legally dissolved in June 2025. All intercompany transactions and balances have been eliminated. References herein to “we,” “us,” “our,” or the “Company” mean OraSure and its consolidated subsidiaries, unless otherwise indicated. The unaudited financial statements, in the opinion of management, include all adjustments (consisting only of normal and recurring adjustments) necessary for a fair presentation of the Company's financial position and results of operations for these interim periods. These financial statements should be read in conjunction with the financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025. Results of operations for the three and six months ended June 30, 2026 are not necessarily indicative of the results of operations expected for the full year.

Summary of Significant Accounting Policies

There have been no changes to the Company's significant accounting policies described in its Annual Report on Form 10-K for the fiscal year ended December 31, 2025 that have had a material impact on the consolidated financial statements and related notes except as discussed herein.

Cash Equivalents & Short-Term Investments

The Company considers all its investments in debt securities to be available-for-sale securities. These securities consist of guaranteed investment certificates purchased with maturities greater than ninety days and are considered short-term investments. Securities with maturities ninety days or less are considered cash equivalents. Available-for-sale securities are carried at fair value, based upon quoted market prices, with unrealized gains and losses, if any, reported in stockholders’ equity as a component of accumulated other comprehensive loss.

The Company records an allowance for credit loss for the Company's available-for-sale securities when a decline in investment market value is due to credit-related factors. When evaluating an investment for impairment, the Company reviews factors such as the severity of the impairment, changes in underlying credit ratings, forecasted recovery, the Company’s intent to sell or the likelihood that it would be required to sell the investment before its anticipated recovery in market value, and the probability that the scheduled cash payments will continue to be made.

The Company maintains cash balances in the United States in excess of the federally insured limits. The Company periodically evaluates financial institutions and believes the risk of loss to be remote due to this evaluation.

Fair Value of Financial Instruments

As of June 30, 2026 and December 31, 2025, the carrying values of cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their respective fair values based on their short-term nature.

Fair value measurements of all financial assets and liabilities that are being measured and reported on a fair value basis are required to be classified and disclosed in one of the following three categories:

Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;

Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and

Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).

To the extent that valuation is based on models or inputs that are unobservable in the market, determining fair value requires more judgment. Because of the inherent uncertainty of valuation, estimated values may be materially higher or lower than the values that would have been used had a ready market for the investments existed. Therefore, the degree of judgment exercised in determining fair value is greatest for assets or liabilities categorized in Level 3. The following table provides a summary of the recognized assets and liabilities that are measured at fair value on a recurring basis:


		June 30,		December 31,
	Level	2026		2025
Guaranteed investment certificates	1	$	12,796	$	13,114
Trading securities	1	525		543
Contingent consideration:	3
Current portion		$	—	$	18,380
Long-term portion		5,233		9,333
		$	5,233	$	27,713

Included in cash and cash equivalents at June 30, 2026 and December 31, 2025 was $12.8 million and $13.1 million, respectively, invested in guaranteed investment certificates.

Included in cash and cash equivalents at June 30, 2026 and December 31, 2025, was $49.6 million and $68.4 million, respectively, invested in government money market funds. These funds have investments in U.S. government securities and are measured as Level 1 instruments.

The Company offers a nonqualified deferred compensation plan for certain eligible employees and members of the Company's Board of Directors. The assets of the plan are held in the name of the Company at a third-party financial institution. The Company paused the plan in January 2026 and is no longer allowing new participants to enter the plan. Separate accounts are maintained for each participant to reflect the amounts deferred by the participant and all earnings and losses on those deferred amounts. The assets of the plan are held in mutual funds and Company stock. The fair value of the plan assets as of June 30, 2026 and December 31, 2025 was $0.5 million, and was calculated using the quoted market prices of the assets as of those dates. All investments in the plan are classified as trading securities and measured as Level 1 instruments. The fair value of plan assets is included in both current assets and other noncurrent assets with the same amounts included in accrued expenses and other noncurrent liabilities in the accompanying consolidated balance sheets.

Contingent Consideration

The Company has identified its contingent consideration obligations as Level 3 liabilities due to significant inputs that are required to measure the fair value of these obligations. The contingent consideration is comprised of three different tranches: milestone payments, royalty payments, and earnout payments. The significant quantitative unobservable inputs for the milestone payments are the discount rate and probability of achieving regulatory approval milestones. In December 2025, the Company submitted a premarket notification, or 510(k), to the U.S. Food and Drug Administration (the “FDA”) for clearance of its rapid molecular self-test for chlamydia trachomatis and Neisseria gonorrhoeae (“CT/NG”) on the Sherlock platform. Following constructive interactions with the FDA, the Company is updating its submission plan for the CT/NG test on the Sherlock platform to incorporate feedback received from the agency. As part of this process, in July 2026, the Company elected to withdraw its current submission and plans to pursue a future submission based on a new clinical trial. Due to this withdrawal, the Company has concluded that it will not obtain FDA clearance by December 31, 2026 as outlined in the terms of the merger agreement. Accordingly, the Company will not be obligated to pay the milestone contingent payments and the milestone contingent consideration liability was reduced to zero. Furthermore, as a result in the delay in the commercialization of the CT/NG product, the royalty based contingent consideration liability was reduced to reflect the delay in recognizing revenue from the sale of the CT/NG product and increase in discount rate associated with the cash flows. During the three and six months ended June 30, 2026, to reflect these changes in these liabilities, a decrease in the estimated fair value of acquisition-related contingent consideration of $22.6 million and $22.5 million, respectively, was recorded on the Company's consolidated statement of operations.

The fair value methodology for royalty payments is based on a discounted cash flow model. Significant quantitative unobservable inputs are internally developed future expected cash flows, discount rate and probability achievement of a milestone of a regulatory approval. The royalty payments represent a mid-single digit percentage of the net sales through 2034 associated with the acquired in-process and research and development intangible asset.

The fair value methodology for earnout payments is based on a Monte Carlo model. Significant quantitative unobservable inputs are future expected cash flows, discount rate and volatility rate.

There has been a net decrease of $17.9 million in the fair value of the Company's contingent consideration from date of acquisition to June 30, 2026 primarily due to the release of the milestone liability and a reduction in royalty liability as described above.


	Fair Value
Balance at December 31, 2025	$	27,713
Additions	—
Change in fair value	(22,480)
Balance at June 30, 2026	$	5,233

The below table illustrates the discount rate sensitivity to the fair value of the royalty liability when performing the fair value analysis as of June 30, 2026. The fair value analysis as of June 30, 2026, utilized a 20.4% discount rate.


Fair Value of Royalty Payments
Discount Rate
18.4%	19.4%	20.4%	21.4%	22.4%
$5,600	$5,300	$5,000	$4,700	$4,400

Indefinite-Lived Intangible Asset

Indefinite-lived intangible assets are not amortized but rather tested annually for impairment or more frequently if the Company believes that indicators of impairment exist. Current generally accepted accounting principles permit the Company to make a qualitative evaluation about the likelihood of indefinite-lived intangible asset impairment. If the Company concludes that it is more likely than not that the carrying value of an indefinite-lived intangible asset is greater than its fair value, then the Company would be required to perform a quantitative analysis. The Company would recognize an impairment charge for the amount by which the carrying amount exceeds the fair value.

In December 2025, the Company submitted a 510(k) to the FDA for clearance of its rapid molecular self-test for CT/NG. Following constructive interactions with the FDA, the Company is updating its submission plan for the CT/NG test on the Sherlock platform to incorporate feedback received from the agency. As part of this process, in July 2026, the Company elected to withdraw its current submission and plans to pursue a future submission. This withdrawal was considered an indicator of impairment, which necessitates review of the facts and circumstances underlying the value of the in-process research and development ("IPR&D") technology intangible asset as of June 30, 2026. The Company performed a quantitative indefinite-lived intangible asset impairment test on the IPR&D technology which concluded that the carrying value of the Company's IPR&D technology was below its fair value indicating there was no impairment as of June 30, 2026. The carrying value was 6% below its fair value.

As of June 30, 2026, the IPR&D technology intangible asset was $17.0 million. The impairment analysis used an income approach. The income approach estimates fair value for an asset based on the present value of cash flows projected to be generated by the asset. Projected cash flows are discounted at a required rate of return that reflects the relative risk of achieving the cash flows and the time value of money. The revenue and cash flows assumes CT/NG receives regulatory authorization and market competition of future products is low. The revenues assume market growth will accelerate each year. If there are delays to attaining regulatory approval or successfully launching CT/NG, this could have a negative outcome on the indefinite-lived intangible asset impairment analysis.

The below table illustrates the discount rate sensitivity to the fair value of the IPR&D technology intangible asset when performing the impairment analysis as of June 30, 2026. In the IPR&D technology intangible asset impairment analysis as of June 30, 2026, the impairment analysis utilized a 40% discount rate.


Discount Rate
38.0%	39.0%	40.0%	41.0%	42.0%
$22,000	$20,000	$18,000	$17,000	$15,000

Equity Method Investee

In January 2024, the Company led the Series B financing and entered into wide-ranging strategic distribution agreements with KKR Sapphiros L.P. ("Sapphiros"), a privately held consumer diagnostic portfolio company, and certain of its related entities. Through this relationship, the Company expects to be able to offer a more comprehensive range of low-cost diagnostic tests and molecular sample management solutions to the Company's customers globally. As of June 30, 2026, the Company had funded $30.0 million for its interest in Sapphiros. The Company recorded the investment using the equity method in accordance with Accounting Standards Codification ("ASC") Topic 323, Investments—Equity Method and Joint Ventures—Overall. In accordance with the equity method, the Company's equity investment is presented net of its share of any gains or losses of the investee. The Company has elected as its accounting policy to recognize its share of any income or loss in Sapphiros on a three-month lag. The value of the investment in Sapphiros of $24.4 million as of June 30, 2026 is included in the investment in equity method investee line of the Company's balance sheet. The Company has no unconditional obligations or guarantees to, or in support of, its equity method investee and its operations. In conjunction with the preparation of the Company's June 30, 2026 financial statements, the Company evaluated the investment in Sapphiros for impairment and concluded there was no such impairment. The Company's investment in Sapphiros was valued at $26.0 million as of December 31, 2025.

Related Party

The Company loaned Sapphiros $0.3 million during the year ended December 31, 2025. The loan plus interest is due in December 2026. During the year ended December 31, 2025, the Company entered into an agreement with Sapphiros to assist in the development of certain products for Sapphiros. A total of $0.1 million and $0.2 million of products and services revenue was recognized from this agreement for the for the three and six months ended June 30, 2026. No equivalent amounts were recognized for the three and six months ended June 30, 2025.

Uncertain Tax Positions

Assets and liabilities are established for uncertain tax positions taken or positions expected to be taken in income tax returns when such positions fail to meet the "more likely than not" threshold based on the technical merits of the positions. The Company assesses whether previously unrecognized tax benefits may be recognized when tax positions are (1) more likely than not of being sustained based on their technical merits, (2) effectively settled through examination, negotiation or litigation, or (3) settled through actual expiration of the relevant tax statutes. The assessment of an uncertain tax position requires significant judgment.

Foreign Currency Transactions

Net foreign exchange losses resulting from foreign currency transactions that are included in other income in the Company's consolidated statements of operations were $0.1 million and $0.9 million for the three months ended June 30, 2026 and 2025, respectively.

Net foreign exchange gains (losses) resulting from foreign currency transactions for the six months ended June 30, 2026 and 2025 were $0.1 million and $(1.3) million respectively.

Accumulated Other Comprehensive Loss

Change in accumulated other comprehensive loss by component is listed below:


	Foreign Currency		Total
Balance at December 31, 2025	$	(18,404)	$	(18,404)
Other comprehensive loss	(3,493)		(3,493)
Balance at June 30, 2026	$	(21,897)	$	(21,897)

Recent Accounting Pronouncements

In November 2024, the Financial Accounting Standards Board ("FASB") issued Accounting Standard Update ("ASU") No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40), Disaggregation of Income Statement Expenses. The purpose of this update was to require disclosure, in the notes to financial statements, of specified information about certain costs and expenses on a disaggregated basis. The amendments in the ASU are effective for all public business entities for annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted. The amendments are to be applied either prospectively to financial statements issued for reporting periods after the effective date of the update or retrospectively to any or all prior periods presented in the financial statements. Management is evaluating the impact on the Company's consolidated financial statements.

In July 2025, the FASB issued ASU No. 2025-05, Financial Instruments—Credit Losses (Topic 326), Measurement of Credit Losses for Accounts Receivable and Contract Assets. The purpose of this update was to address challenges encountered when applying the guidance in Topic 326, Financial Instruments—Credit Losses, to current accounts receivable and current contract assets arising from transactions accounted for under Topic 606, Revenue from Contracts with Customers. For all business entities, the amendments in this ASU are effective for fiscal years beginning after December 15, 2025, and interim periods within those fiscal periods. The amendments are applied prospectively, and early adoption is permitted. Management does not expect a material impact on the Company's consolidated financial statements.

In September 2025, the FASB issued ASU No. 2025-06, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40), Targeted Improvements to the Accounting for Internal-Use Software. The purpose of this update was to modernize the accounting for software costs. For all business entities, the amendments in this ASU are effective for fiscal years beginning after December 15, 2027, and interim periods within those fiscal periods. The amendments can be applied prospectively, a modified transition or retrospectively. Early adoption is permitted as of the beginning of an annual reporting period. Management does not expect a material impact on the Company's consolidated financial statements.

In December 2025, the FASB issued ASU No. 2025-10, Government Grants (Topic 832), Accounting for Government Grants Received by Business Entities. The purpose of this update was to improve US GAAP by establishing authoritative guidance on the accounting for government grants received by business entities. For public business entities, the amendments in this ASU are effective for annual reporting periods beginning after December 15, 2028, and interim reporting periods within those annual reporting periods. Early adoption is permitted in both interim and annual reporting periods in which financial statements have not yet been issued or made available for issuance. The amendments can be applied under a modified prospective approach, a modified retrospective approach, or a retrospective approach. Management is evaluating the impact on the Company's consolidated financial statements.

In December 2025, the FASB issued ASU No. 2025-11, Interim Reporting (Topic 270), Narrow-Scope Improvements. The purpose of this update was to improve the navigability of the required interim disclosures and clarifying when that guidance is applicable. The update also provides additional guidance on what disclosures should be provided in interim periods and adds a principal that requires entities to disclose events since the end of the last annual reporting period that have a material impact on the entity. For public business entities, the amendments in this ASU are effective for interim reporting periods within annual reporting periods beginning after December 15, 2027. Early adoption is permitted. The amendments in this update can be applied either prospectively or retrospectively to any or all prior periods presented in the financial statements. Management is evaluating the impact on the Company's consolidated financial statements.

2. INVENTORIES:


	June 30,		December 31,
	2026		2025
Raw materials	$	15,781	$	14,831
Work in process	1,110		56
Semi-finished goods	2,601		1,965
Finished goods	10,579		14,208
	$	30,071	$	31,060

3. PROPERTY, PLANT, AND EQUIPMENT, NET:


	June 30,		December 31,
	2026		2025
Land	$	1,118	$	1,118
Buildings and improvements	39,029		39,071
Machinery and equipment	46,232		46,202
Computer equipment and software	11,870		11,101
Furniture and fixtures	1,609		1,632
Construction in progress	5,527		2,931
	105,385		102,055
Accumulated depreciation	(66,808)		(62,876)
	$	38,577	$	39,179

4. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES:


	June 30,		December 31,
	2026		2025
Payroll and related benefits	$	8,140	$	5,255
Professional fees	2,891		1,938
Sales tax payable	1,044		1,152
Other	1,643		2,804
	$	13,718	$	11,149

5. TERMINATION BENEFITS:

Q2 2024 Reduction in Workforce

During the second quarter of 2024, the Company executed a reduction in workforce as the Company notified employees of its intention to consolidate its Novosanis site in Belgium into other locations by the end of December 31, 2024, discontinue the Diversigen molecular services line of business by the end of June 30, 2024, and consolidate facilities by bringing third-party manufacturing activities into its Pennsylvania facilities by the end of the third quarter of 2025.

As of March 31, 2026 the Company had paid the full $1.7 million related to the reduction in workforce. This reduction in workforce was completed by March 31, 2026 and no additional charges were incurred during the six months ended June 30, 2026.

Q3 2024 Reduction in Workforce

During the third quarter of 2024, the Company executed a reduction in workforce as the Company notified certain employees of its intention to discontinue its risk assessment business. Additional employees were notified in the fourth quarter of 2024.

As of June 30, 2026, the Company had $0.1 million accrued and had paid $1.2 million related to this reduction in workforce. No additional charges were incurred during the six months ended June 30, 2026. The Company expects this reduction in workforce to be completed by October 2026.

Q1 2026 Reduction in Workforce

During the first quarter of 2026, the Company executed a reduction in workforce to better align the Company's cost structure. The charges for termination benefits included in the Company's consolidated statements of operations are as follows:


	For the Six Months Ended June 30,
	2026
Cost of products and services sold	$	65
Research and development	264
Sales and marketing	260
General and administrative	680
	$	1,269

As of June 30, 2026, the Company had $0.5 million accrued and had paid $0.8 million related to the reduction in workforce. No additional charges were incurred during the six months ended June 30, 2026. The Company expects this reduction in workforce to be completed by February 2027.

6. REVENUES:

Revenues by Product Line. The following table represents total net revenues by product line:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2026		2025		2026		2025
HIV	$	14,170	$	14,398	$	27,189	$	27,298
Sample Management Solutions (1)	9,875		9,855		18,933		18,965
HCV	3,393		4,126		6,056		8,459
Other product and services revenues (2)	2,285		994		3,903		1,767
COVID-19 (3)	1		28		19		489
Risk Assessment Testing (4)	—		446		—		1,866
Net product and services revenues	$	29,724	$	29,847	$	56,100	$	58,844
Non-product and services revenues (5)	915		1,395		2,464		2,329
Net revenues	$	30,639	$	31,242	$	58,564	$	61,173

(1) Includes Genomics, Microbiome and Colli-Pee® product revenues.

(2) Includes Syphilis revenues and single order fulfillment.

(3) Includes COVID-19 Diagnostics and COVID-19 Sample Management Solutions revenues.

(4) Includes substance abuse testing product revenues.

(5) Includes funded research and development contracts, royalty income and grant revenues.

Revenues by Geographic Area. The following table represents total net revenues by geographic area, based on the location of the customer:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2026		2025		2026		2025
United States	$	20,235	$	19,852	$	38,907	$	40,187
Africa	6,786		8,027		13,560		15,216
Europe	1,743		2,117		3,192		3,754
Other regions	1,875		1,246		2,905		2,016
	$	30,639	$	31,242	$	58,564	$	61,173

Customer Concentrations. The following table represents customer concentration risk:






	June 30,		December 31,
Accounts Receivable	2026		2025
Commercial customer (1)	14	%	N/A
Commercial customer (1)	11	%	15	%

(1) Each commercial customer is a different international distributor.

Vendor Concentrations. The Company currently purchases certain products and critical components of the Company's products from sole-supply vendors. If these vendors are unable or unwilling to supply the required components and products, the Company could be subject to increased costs and substantial delays in the delivery of the Company's products to its customers. Third-party suppliers also manufacture certain products. The Company's inability to have a timely supply of any of these components and products could have a material adverse effect on the Company's business, as well as the Company's financial condition and results of operations.

Deferred Revenue. The Company records deferred revenue when funds are received prior to the recognition of the associated revenue. Deferred revenue as of June 30, 2026 and December 31, 2025 was comprised of customer prepayments of $0.9 million and $1.2 million, respectively. Deferred revenue as of December 31, 2025 was also comprised of $0.4 million of unearned grant income. The Company had no unearned grant income in deferred revenue as of June 30, 2026.

The following table represents deferred revenue recognized:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
Deferred Revenue Recognized	2026		2025		2026		2025
Accrued at beginning of year	$	148	$	974	$	1,109	$	1,461

7. INCOME TAXES:

The components of the income tax expense (benefit) are as follows:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2026		2025		2026		2025
Federal income tax expense	$	3	$	157	$	7	$	165
State income tax expense	26		2,394		54		2,403
Foreign income tax expense (benefit)	26		(551)		(438)		(1,024)

	$	55	$	2,000	$	(377)	$	1,544

During the three months ended June 30, 2026 and 2025, the Company recorded income tax expense of $0.1 million and $2.0 million, respectively. During the six months ended June 30, 2026 and 2025, the Company recorded an income tax benefit of $0.4 million and income tax expense of $1.5 million, respectively. The higher federal and state income tax expense in 2025 is largely due to recording an uncertain tax position for certain tax matters, including penalties and interest. During the three and six months ended June 30, 2026, the Company had an effective tax rate of 0.8% and 2.5%, respectively. During the three and six months ended June 30, 2025, the Company had an effective tax rate of (11.8)% and (4.7)%, respectively. The increase in the Company's tax rate was primarily due to the recording of the uncertain tax position in 2025 and projected break-even results in foreign operations in 2026 versus projected losses in 2025.

Income tax expense reflects taxes due to the taxing authorities and the tax effects of temporary differences between the basis of assets and liabilities recognized for financial reporting and tax purposes, and net operating loss and tax credit carryforwards.

A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized. A full valuation allowance was recorded on the Company’s U.S. and U.K. deferred tax assets as of June 30, 2026 and December 31, 2025.

Uncertain tax positions were approximately $2.0 million as of June 30, 2026 and December 31, 2025. The Company’s uncertain tax position relates to U.S. federal and other jurisdictions. Due to various factors, including the inherent complexities and uncertainties of the judicial, administrative, and regulatory processes in certain jurisdictions, the timing of the resolution of income tax controversies is highly uncertain, and the amounts ultimately paid, if any, upon resolution of the issues raised by the taxing authorities may differ from the amounts accrued. Any assessments or settlements could result in changes to the Company's contingencies related to positions on prior years’ tax filings.

8. EARNINGS (LOSS) PER SHARE:

Basic earnings (loss) per share is computed by dividing net income (loss) by the weighted-average number of shares of common stock outstanding during the period. Diluted earnings (loss) per share is computed in a manner similar to basic earnings (loss) per share except that the weighted-average number of shares outstanding is increased to include incremental shares from the assumed vesting or exercise of dilutive securities, such as common stock options, unvested restricted stock or performance stock units, unless the impact is anti-dilutive. The number of incremental shares is calculated by assuming that outstanding stock options were exercised and unvested restricted shares and performance stock units were vested, and the proceeds from such exercises or vesting were used to acquire shares of common stock at the average market price during the reporting period. Basic and dilutive computations of net loss per share are the same in periods in which a net loss exists as the dilutive effects of excluded items would be anti-dilutive.

For the three months ended June 30, 2026, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 4,108 shares were excluded from the computation of diluted earnings per share as their inclusion would have been anti-dilutive.

For the three months ended June 30, 2025, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 581 shares were excluded from the computation of diluted loss per share.

For the six months ended June 30, 2026 and 2025, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 913 shares and 618 shares, respectively, were excluded from the computation of diluted loss per share.

9. STOCKHOLDERS' EQUITY:

In March 2025, the Company's Board of Directors authorized a stock repurchase program (the "Repurchase Program") effective March 21, 2025, whereby the Company may purchase up to $40.0 million in shares of its common stock over a period of up to two years. The amount and timing of share repurchases under the Repurchase Program may be carried out at the discretion of the Company's management through various methods in compliance with applicable state and federal securities laws. The Company repurchased 0.6 million and 1.8 million shares of its common stock under the Repurchase Program during the three months ended June 30, 2026 and 2025. The Company repurchased 2.4 million and 1.8 million shares of its common stock under the Repurchase Program during the six months ended June 30, 2026 and 2025.

The reconciliation of the changes in stockholders' equity for the three and six months ended June 30, 2026 and 2025 is as follows:


	Common Stock			Additional Paid-in Capital		Accumulated Other Comprehensive Loss		Accumulated Deficit		Total
	Shares	Amount
Balance at December 31, 2025	70,391	$	—	$	531,393	$	(18,404)	$	(172,162)	$	340,827

Vesting of restricted stock and performance stock units	1,190	—		—		—		—		—
Purchase and retirement of common shares in satisfaction of minimum tax withholdings for vested restricted stock and performance stock units	(416)	—		(1,261)		—		—		(1,261)
Stock-based compensation	—	—		2,768		—		—		2,768
Shares repurchased and retired in connection with share repurchase program	(1,768)	—		(5,000)		—		—		(5,000)
Net loss	—	—		—		—		(22,377)		(22,377)
Currency translation adjustments	—	—		—		(1,633)		—		(1,633)

Balance at March 31, 2026	69,397	$	—	$	527,900	$	(20,037)	$	(194,539)	$	313,324

Vesting of restricted stock and performance stock units	291	—		—		—		—		—
Purchase and retirement of common shares in satisfaction of minimum tax withholdings for vested restricted stock and performance stock units	(73)	—		(223)		—		—		(223)
Stock-based compensation	—	—		2,287		—		—		2,287
Shares repurchased and retired in connection with share repurchase program	(647)	—		(2,000)		—		—		(2,000)
Net income	—	—		—		—		6,249		6,249
Currency translation adjustments	—	—		—		(1,860)		—		(1,860)

Balance at June 30, 2026	68,968	$	—	$	527,964	$	(21,897)	$	(188,290)	$	317,777


	Common Stock			Additional Paid-in Capital		Accumulated Other Comprehensive Loss		Accumulated Deficit		Total
	Shares	Amount
Balance at December 31, 2024	74,598	$	—	$	538,129	$	(24,360)	$	(103,431)	$	410,338

Vesting of restricted stock and performance stock units	768	—		—		—		—		—
Purchase and retirement of common shares in satisfaction of minimum tax withholdings for vested restricted stock and performance stock units	(252)	—		(941)		—		—		(941)
Stock-based compensation	—	—		2,687		—		—		2,687

Net loss	—	—		—		—		(16,040)		(16,040)
Currency translation adjustments	—	—		—		238		—		238

Balance at March 31, 2025	75,114	$	—	$	539,875	$	(24,122)	$	(119,471)	$	396,282
Vesting of restricted stock and performance stock units	713	—		—		—		—		—
Purchase and retirement of common shares in satisfaction of minimum tax withholdings for vested restricted stock and performance stock units	(271)	—		(784)		—		—		(784)
Stock-based compensation	—	—		3,165		—		—		3,165
Shares repurchased and retired in connection with share repurchase program	(1,821)			(5,000)		—		—		(5,000)
Net loss	—	—		—		—		(19,693)		(19,693)
Currency translation adjustments	—	—		—		6,751		—		6,751

Balance at June 30, 2025	73,735	$	—	$	537,256	$	(17,371)	$	(139,164)	$	380,721

10. BUSINESS SEGMENT INFORMATION:

The Company is organized on the basis of products and services into a single reportable segment. All products and services reside under the same reporting hierarchy. The Company's reportable segment derives its revenues from the sale of diagnostics products and sample management solutions, as described in Note 1 Summary of Significant Accounting Policies. As the Company has only one reportable segment, there are no inter-segment sales or transfers.

The Company's Chief Operating Decision Maker ("CODM") is its Chief Executive Officer. The CODM uses consolidated net income (loss) as reported in the consolidated statement of operations as the primary measure of the reportable segment's profit or loss. The CODM uses consolidated net income (loss) to assess the performance of the segment and make decisions about resource allocation. Consolidated gross profit and consolidated operating income (loss), as reported in the consolidated statement of operations, are also used by the CODM as measures of segment profit or loss. The CODM uses gross profit to assess the impact of the Company's efforts to achieve manufacturing efficiencies and consolidate its production activities. The CODM uses operating income (loss) to assess the impact of the Company's recent restructurings, reduction in workforce, and efforts to streamline its operations to achieve cost savings. The CODM uses consolidated total assets as the measure of segment assets, as reported on the consolidated balance sheet.

The accounting policies of the Company's reportable segment are the same as those described in Note 1 Summary of Significant Accounting Policies.

The following table represents total long-lived assets by geographic area:


	June 30,		December 31,
	2026		2025
United States	$	36,548	$	36,254
United Kingdom	8,982		10,061
Canada	4,003		4,642
Other regions	315		364
	$	49,848	$	51,321

The following table represents reported segment revenues, segment loss, and significant segment expenses:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2026		2025		2026		2025
Net revenues	$	30,639	$	31,242	$	58,564	$	61,173
Cost of products and services sold (2)	17,322		18,083		33,443		35,715
Gross profit	13,317		13,159		25,121		25,458
Research and development (2)	9,437		11,401		23,091		21,004
Sales and marketing (2)	6,604		6,375		13,374		13,234
General and administrative (2)	14,429		12,676		28,985		26,778

Change in the estimated fair value of acquisition-related contingent consideration	(22,573)		733		(22,480)		1,211
Gain on sale of assets	(20)		—		(20)		(993)
Operating income (loss)	5,440		(18,026)		(17,829)		(35,776)
Other income (expense)	235		—		404		(16)
Interest revenue	1,205		2,073		2,425		4,228
Other segment items (1)	(63)		(938)		96		(1,299)
Income (loss) before income taxes and equity investment	6,817		(16,891)		(14,904)		(32,863)
Income tax expense (benefit)	55		2,000		(377)		1,544
Loss on equity investment	(513)		(802)		(1,601)		(1,326)
Net income (loss)	$	6,249	$	(19,693)	$	(16,128)	$	(35,733)

(1) Includes interest expense and foreign currency gains (losses).

(2) The following tables represent additional significant segment expense categories:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2026		2025		2026		2025
Stock-based Compensation
Cost of products and services sold	$	191	$	207	$	381	$	376
Research and development	357		279		637		482
Sales and marketing	215		217		419		435
General and administrative	1,524		2,462		3,618		4,559
	$	2,287	$	3,165	$	5,055	$	5,852


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2026		2025		2026		2025
Depreciation & Amortization
Cost of products and services sold	$	976	$	1,060	$	1,968	$	2,449
Research and development	176		569		525		1,054
Sales and marketing	173		30		175		57
General and administrative	1,046		868		2,044		1,775
	$	2,371	$	2,526	$	4,712	$	5,334

11. BUSINESS COMBINATIONS:

BioMedomics

On November 12, 2025, the Company acquired all of the outstanding stock of BioMedomics, pursuant to the terms of an acquisition agreement (the "Acquisition Agreement"). The Company began operating this entity as of the November 12, 2025 closing date.

The primary reason for the acquisition of BioMedomics was to expand the Company's diagnostic portfolio by adding SickleSCAN®, a rapid, point-of-need test for sickle cell disease that is sold outside of the United States.

The initial aggregate purchase price of this transaction was funded with cash on hand as shown in the table below:


Cash paid to BioMedomics	$	2,865
Transaction expenses	403
Debt paid off	330
Earnout contingent consideration	233
Expense fund	40
Initial aggregate purchase price	$	3,871

Pursuant to the Acquisition Agreement, the Company agreed to pay up to $5.0 million of contingent consideration based on the achievement of sales thresholds before December 31, 2031. The acquisition-date fair value of the earnout contingent consideration was $0.2 million. The range of outcome for the earnout contingent consideration is zero to $5.0 million.

During the year ended December 31, 2025, the Company incurred a total of $0.5 million of acquisition related costs, including accounting, legal, and other professional fees, all of which were expensed and reported as a component of general and administrative expenses in the consolidated statement of operations for the year ended December 31, 2025.

The following table summarizes the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date:


Assets Acquired


Other current and non current assets	$	10
Inventory	284
Operating right-of-use assets	120


Developed technology intangible asset	1,900
Goodwill	1,775
Total assets acquired	4,089
Liabilities Assumed
Accounts payable	34
Current liabilities	17
Deferred revenue	72
Operating lease liability	120
Total liabilities assumed	243
Net Assets Acquired	3,846
Estimated fair value of contingent consideration	(233)
Net Cash Paid (net of cash acquired of $25)	$	3,613

The purchase price was allocated to the tangible assets and identifiable intangible asset acquired and liabilities assumed based on their acquisition-date estimate fair values. The identifiable intangible asset was developed technology. The developed technology was all assigned a ten year useful life.

The Company, with the assistance of an independent valuation specialist, assessed the fair value of the intangible asset and contingent consideration of BioMedomics. The fair values recorded as of November 12, 2025 are based on significant inputs that are not observable in the market and thus represent a fair value measurement categorized within Level 3 of the fair value hierarchy.

The fair value of the acquired developed technology was determined using the multi-period excess earnings method, which required judgment in estimating appropriate cash flows, discount rate, survival factor, and remaining useful life.

The fair value of the earnout contingent consideration was determined using the Monte Carlo simulation model, which required judgment in estimating expected revenue, volatility, expected discount rate and risk-free interest rate.

Goodwill is calculated as the difference between the acquisition date fair value of the consideration transferred and the fair value of the net assets acquired, and represents the future economic benefits that the Company expects to achieve as a result of the acquisition. The Company believes the goodwill related to the acquisition was a result of BioMedomics providing a product that will enable the Company to leverage the product with existing and new customers. The goodwill is not deductible for income tax purposes.

The Company continues to evaluate the fair value of assets acquired and liabilities assumed. Additional information, which existed as of the acquisition date, but was at that time unknown to the Company, may become known during the remainder of the measurement period. Changes to amounts recorded as a result of the final determination may result in a corresponding adjustment to these assets and liabilities, including goodwill. The determination of the estimated fair values of all assets acquired was completed as of June 30, 2026.

Revenues from BioMedomics consist of sales from the SickleSCAN® test. Effective as of November 12, 2025, the financial results of BioMedomics are included in the consolidated financial results of the Company. BioMedomics contributed $0.1 million and $1.1 thousand of revenue and net income, respectively, to the consolidated statement of operations for the year ended December 31, 2025.

Unaudited Pro Forma Financial Information

The unaudited pro forma results presented below include the results of the BioMedomics acquisition as if it had been consummated as of January 1, 2025. The unaudited pro forma results include amortization of the acquired intangible asset, stock compensation, and lease expense adjustments to income before income taxes but do not include changes in the fair value of the Company's contingent consideration obligations. Material nonrecurring charges, directly attributable to the transactions, including direct acquisition costs, are also excluded. In addition, the unaudited pro forma results do not include any expected benefits of the acquisitions. Accordingly, the unaudited pro forma results are not necessarily indicative of either future results of operations or results that might have been achieved had the acquisition been consummated as of January 1, 2025.


	For the Three Months Ended June 30,		For the Six Months Ended June 30,
	2025		2025
Net revenues	$	31,491	$	61,695
Net loss	$	(52,784)	$	(35,771)

12. CONTINGENCIES:

Collaborations

Sherlock has active third-party license agreements entered into in order to advance and obtain technologies and services related to the business. Under these licenses, the Company is required to make up to $3.3 million of cash payments upon the achievement of certain scientific and commercial milestones as well as low single digit royalty payments on product sales. The Company has the right to terminate the licenses.

Litigation

From time to time, the Company is involved in certain legal actions arising in the ordinary course of business. In management’s opinion, based upon the advice of counsel, the outcomes of such actions are not expected, individually or in the aggregate, to have a material adverse effect on the Company's future financial position or results of operations.

On November 14, 2024 the Company filed a complaint against NowDiagnostics, Inc. ("NowDx"), Jody Berry ("Berry") and Janean Young ("Young") in the United States District Court for the Eastern District of Pennsylvania alleging misappropriation and misuse of the Company's proprietary information and trade secrets by NowDx, Berry and Young in violation of the Federal Defend Trade Secrets Act and the Pennsylvania Uniform Trade Secrets Act. The complaint also alleges breach of contract and duty of loyalty by Young, unfair competition by NowDx, and tortious interference with contractual relations by Berry and NowDx. NowDx filed Counterclaims against the Company on January 13, 2025 and the Company filed its Answer to the Counterclaims on February 3, 2025. Young filed a Motion to Dismiss the claims against her, which was denied by the court on February 4, 2025. NowDx, Berry, and Young agreed to a preliminary injunction which the Court entered on February 27, 2025 and that remains in place. On February 11, 2026, the Court issued an order scheduling trial for January 17, 2027.

13. SUBSEQUENT EVENTS:

In December 2025, the Company submitted a 510(k) to the FDA for clearance of its rapid molecular self-test for CT/NG. Following constructive interactions with the FDA, the Company is updating its submission plan for the CT/NG Test on the Sherlock platform to incorporate feedback received from the agency. As part of this process, in July 2026, the Company elected to withdraw its current submission and plans to pursue a future submission based on a new clinical trial. Due to the withdrawal, the Company has concluded that it will not obtain FDA clearance by December 31, 2026 as outlined in the terms of the merger agreement. Accordingly, the Company will not be obligated to pay the milestone contingent payments and the milestone contingent consideration liability was reduced to zero. Furthermore, as a result of the delay in the commercialization of the CT/NG product, the royalty-based contingent consideration liability was reduced to reflect the delay in recognizing revenue from the sale of the CT/NG product. These reductions in the contingent consideration liabilities are reflected in the change in the estimated fair value of acquisition-related contingent consideration line in the consolidated statement of operations.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of the Company's financial condition and results of operations should be read in conjunction with (i) the Company's unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and (ii) the Company's audited consolidated financial statements and related notes and management’s discussion and analysis of financial condition and results of operations included in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission on March 9, 2026. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to the Company's plans and strategy for its business and impact and potential impacts on its business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including, without limitation, those factors set forth in the “Risk Factors” section of the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and the “Risk Factors” section of subsequent Quarterly Reports on Form 10-Q, the Company's actual results or timing of certain events could differ materially from the results or timing described in, or implied by, these forward-looking statements.

Business Overview

The Company's business consists of the development, manufacture, marketing, sale and distribution of simple, easy to use diagnostic products and specimen collection devices using its proprietary technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types. The Company's diagnostic products include tests for diseases including HIV, Hepatitis C, Syphilis, Sickle Cell and COVID-19 that are performed on a rapid basis at the point of care. These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations, and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities. The Company's HIV and COVID-19 products are also sold in a consumer-friendly format in the over-the-counter ("OTC") market in the U.S. and, in the case of the HIV and HCV products, as a self-test to individuals in a number of other countries, including, for the HIV products, as an oral swab in-home test for HIV-1 and HIV-2 in Europe, and for the HCV products, as an OTC test.

The Company's business also includes sample management solutions and services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers. The revenues from sample management solutions are derived from product sales to commercial customers and sales into the academic and research markets. Customers span the disease risk management, diagnostics, pharmaceutical, biotech, and companion animal market segments. The Company has also developed collection devices for the emerging microbiome market, which focuses on studying microbiomes and their effect on human and animal health. The Company also has a urine collection device which allows for the volumetric collection of first void urine. Initial sales of this product for research use only are occurring primarily through distributors and collaborations in the liquid biopsy and sexually transmitted disease markets. In December 2025, the Company submitted a 510(k) to the FDA for clearance of its Colli-Pee® at-home urine collection device for sexually transmitted infections, which was approved in June 2026.

Risk Assessment Testing

During the third quarter of 2024, the Company announced the discontinuance of sales of its risk assessment product line, which was completed in the second quarter of 2025. Sales of its risk assessment products did not contribute to revenues during the six months ended June 30, 2026. Sales of its risk assessment products contributed $0.4 million to revenues during the three months ended June 30, 2025 and $1.9 million for the six months ended June 30, 2025. During the first quarter of 2025, the Company sold certain assets that made up the risk assessment product line including certain intellectual property, contracts, permits, and equipment.

Recent Developments

In June 2026, the Company received clearance from the FDA of its Colli-Pee™•Dx Urine Collection Kit for use on Roche's tests for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) and to run on Roche’s cobas® 5800, 6800, and 8800 molecular diagnostic systems. The Colli-Pee™•Dx Urine Collection Kit will be sold by the Company's subsidiary DNA Genotek Inc. and supports at-home self-collection of first-void urine, enabling convenient sample collection at-home or in any private setting for both male and female patients.

In July 2026, the Company received Emergency Use Authorization ("EUA") from the FDA for its second generation OraQuick™ Ebola Rapid Antigen Test for use with whole blood in live patients, as well as cadaveric oral fluid from individuals suspected to have had Ebola disease at the time of death. The test can detect all four Ebola viruses currently known to cause disease in humans: Bundibugyo, Zaire, Sudan, and Taï Forest. The OraQuick® Ebola Rapid Antigen Test originally received De Novo marketing authorization from the FDA in 2019, making it the first and only rapid antigen test to receive full authorization for the detection of Ebola virus. The second-generation test authorized by the FDA has increased sensitivity, new chemistry, and a more automated manufacturing process. It was developed in cooperation with the Biomedical Advanced Research and Development Authority (BARDA) under a contract granted in 2022. The current Ebola epidemic, centered in the Democratic Republic of the Congo with cases extending into neighboring Uganda, has already resulted in hundreds of deaths and prompted the World Health Organization to declare a global public health emergency. The Company is ramping up production of the OraQuick™ Ebola 2.0 Rapid Antigen Test to meet potential demand and expand access to a proven, reliable test.

performed demonstrated strong performance compared with centralized laboratory molecular diagnostic methods, and the Company remains encouraged by the product’s performance and its potential to serve an important public health need.

Results of Operations (all dollar amounts in tables are presented in thousands)

For the three months ended June 30, 2026 compared to June 30, 2025.

CONSOLIDATED NET REVENUES

The table below shows total consolidated net revenues for the three months ended June 30, 2026 and 2025:


	For the Three Months Ended June 30,
	Dollars				% Change		Percentage of Total Net Revenues
	2026		2025				2026		2025
Diagnostics (1)	$	19,351	$	19,222	1	%	63	%	62	%
Sample Management Solutions (2)	9,875		9,855		—		32		32
Other products and services (3)	498		324		54		2		1

Risk Assessment Testing (4)	—		446		(100)		—		1
Net product and services revenues	29,724		29,847		—		97		96
Non-product and services revenues (5)	915		1,395		(34)		3		4
Net revenues	$	30,639	$	31,242	(2)	%	100	%	100	%

(1)Includes HIV, HCV, Syphilis, SickleSCAN® and SureQuick® product revenues.

(2)Includes Genomics, Microbiome, and Colli-Pee® product revenues.

(3)Includes COVID-19 Sample Management Solutions and COVID-19 Diagnostics product revenues.

(4)Includes substance abuse testing product revenues.

(5)Includes funded research and development contracts, royalty income and grant revenues.

Product and Services Revenues

Consolidated net revenues decreased 2% to $30.6 million for the three months ended June 30, 2026 from $31.2 million for the three months ended June 30, 2025.

Sales of the Company's Diagnostics products increased 1% to $19.4 million for the three months ended June 30, 2026 from $19.2 million for the three months ended June 30, 2025. This increase was primarily driven by higher syphilis sales resulting from new customers in the women's health market and the inclusion of SickleSCAN® revenues, a new revenue stream acquired through the BioMedomics, Inc. acquisition completed in November 2025. These increases were partially offset by lower HCV revenues due to the expiration and non-renewal of a large customer's HCV testing program, as well as reduced funding associated with other programs. The increase was further offset by lower domestic HIV revenues attributable to lower purchases under the Together Take Me Home Program.

Sample Management Solutions revenues remained largely flat at $9.9 million for the three months ended June 30, 2026 and 2025.

Risk Assessment Testing revenues are $0 in 2026 as the product line was discontinued and wound down in early 2025.

Non-Product and Services Revenues

Non-product and services revenues decreased 34% to $0.9 million for the three months ended June 30, 2026 from $1.4 million for the three months ended June 30, 2025 primarily due to the completion of various funded R&D contracts.

CONSOLIDATED OPERATING RESULTS

Consolidated gross profit margin increased to 43.5% for the three months ended June 30, 2026 compared to 42.1% for the three months ended June 30, 2025. The drivers of the margin increase are attributable to better absorption of fixed overhead costs due to operational efficiencies, partially offset by a negative product mix and lower non-product revenues which contribute 100% to gross margin.

Consolidated operating income for the three months ended June 30, 2026 was $5.4 million compared to an operating loss of $18.0 million for the three months ended June 30, 2025.

Research and development expenses decreased 17% to $9.4 million for the three months ended June 30, 2026 from $11.4 million for the three months ended June 30, 2025 primarily due to lower clinical trial costs associated with the Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) device.

Sales and marketing expenses increased 4% to $6.6 million for the three months ended June 30, 2026 from $6.4 million for the three months ended June 30, 2025.

General and administrative expenses increased 14% to $14.4 million for the three months ended June 30, 2026 from $12.7 million for the three months ended June 30, 2025 largely due to an increase in legal fees and in professional services related to the proxy statement and related stockholder activism costs.

All of the above contributed to the Company's operating income of $5.4 million for the three months ended June 30, 2026, which included non-cash charges of $2.4 million for depreciation and amortization and $2.3 million for stock-based compensation, and $22.6 million in non-cash income reflected in the change in the estimated fair value of acquisition-related contingent consideration. The Company's operating loss of $18.0 million for the three months ended June 30, 2025 included non-cash charges of $3.2 million for stock-based compensation, $2.5 million for depreciation and amortization, and $0.7 million for the change in the estimated fair value of acquisition-related contingent consideration.

OTHER INCOME

Other income for the three months ended June 30, 2026 was $1.4 million compared to $1.1 million for the three months ended June 30, 2025. The increase in other income is due to lower interest income offset by lower foreign currency losses.

CONSOLIDATED INCOME TAXES

The Company continues to believe the full valuation allowance established against its total U.S. and U.K. deferred tax asset is appropriate as the facts and circumstances necessitating the allowance have not changed. For the three months ended June 30, 2026 and 2025, the Company recorded income tax expense of $0.1 million and $2.0 million, respectively. During the three months ended June 30, 2026 and 2025, the Company had an effective tax rate of 0.8% and (11.8)%, respectively. The increase in the Company's tax rate was primarily due to the recording of a uncertain tax position in 2025 and projected break-even results in foreign operations in 2026 versus projected losses in 2025.

Results of Operations

For the six months ended June 30, 2026 compared to June 30, 2025.

CONSOLIDATED NET REVENUES

The table below shows an outline of total consolidated net revenues for the six months ended June 30, 2026 and 2025:


	For the Six Months Ended June 30,
	Dollars				% Change		Percentage of Total Net Revenues
	2026		2025				2026		2025
Diagnostics (1)	$	36,217	$	36,911	(2)	%	62	%	60	%
Sample Management Solutions (2)	18,933		18,965		—		32		31
Other products and services	931		617		51		2		1
COVID-19 Diagnostics	19		485		(96)		—		1
Risk Assessment Testing (3)	—		1,866		(100)		—		3
Net product and services revenues	56,100		58,844		(5)		96		96
Non-product and services revenues (4)	2,464		2,329		6		4		4
Net revenues	$	58,564	$	61,173	(4)	%	100	%	100	%

(1)Includes HIV, HCV, Syphilis, SickleSCAN® and SureQuick® product revenues.

(2)Includes Genomics, Microbiome, and Colli-Pee® product revenues.

(3)Includes substance abuse testing product revenues.

(4)Includes funded research and development contracts, royalty income, and grant revenues.

Product and Services Revenues

Consolidated net revenues decreased 4% to $58.6 million for the six months ended June 30, 2026 from $61.2 million for the six months ended June 30, 2025.

Sales of the Company's Diagnostics products decreased 2% to $36.2 million for the six months ended June 30, 2026 from $36.9 million for the six months ended June 30, 2025. This decline is primarily attributable to lower international HCV revenues driven by reduced reimbursement subsidies in the Asian market and a large order shipped into Africa in the second quarter of 2025 that did not recur. Domestic HCV revenues also declined as a result of a large customer's HCV testing programs ending and not being renewed, as well as reduced funding associated with other programs. In addition, domestic HIV revenues decreased due to lower purchases under the Together Take Me Home program partially offset by higher international revenues associated with timing of customer orders. These decreases were partially offset by higher syphilis sales driven by new customers in the women's health market and the inclusion of SickleSCAN® revenues, a new revenue stream acquired through the BioMedomics, Inc. acquisition completed in November 2025.

Sample Management Solutions revenues remained largely flat at $18.9 million for the six months ended June 30, 2026 and 2025.

COVID-19 Diagnostics revenues decreased 96% to $19.0 thousand for the six months ended June 30, 2026 from $485.0 thousand for the six months ended June 30, 2025 due to lower overall demand for COVID-19 testing.

Risk Assessment testing revenues decreased to zero for the six months ended June 30, 2026 from $1.9 million for the six months ended June 30, 2025. The Company discontinued this line of business at the end of 2024 and the business wound down in early 2025.

Non-Product and Services Revenues

Non-product and services revenues increased 6% to $2.5 million for the six months ended June 30, 2026 from $2.3 million for the six months ended June 30, 2025 primarily due to an increase in funded R&D under certain BARDA contracts.

CONSOLIDATED OPERATING RESULTS

Consolidated gross profit margin increased to 42.9% for the six months ended June 30, 2026 from 41.6% for the six months ended June 30, 2025. The largest driver of the margin improvement is better absorption of fixed overhead costs due to operational efficiencies partially offset by higher scrap expense.

Consolidated operating loss for the six months ended June 30, 2026 was $17.8 million, compared to a $35.8 million operating loss reported for the six months ended June 30, 2025. Results for the six months ended June 30, 2026 benefited from a $22.5 million change in the estimated fair value of acquisition-related contingent consideration but were negatively impacted by the decrease in revenues and by higher operating expenses.

Research and development expenses increased 10% to $23.1 million for the six months ended June 30, 2026 from $21.0 million for the six months ended June 30, 2025 largely due to higher spend incurred for clinical trials for the CT/NG and Colli-Pee® devices.

Sales and marketing expenses remained largely flat at $13.4 million and $13.2 million for the six months ended June 30, 2026 and 2025, respectively.

General and administrative expenses increased 8% to $29.0 million for the six months ended June 30, 2026 from $26.8 million for the six months ended June 30, 2025, largely due to higher professional, consulting, and legal fees associated with the proxy statement, including stockholder activism costs.

All of the above contributed to the Company's operating loss of $17.8 million for the six months ended June 30, 2026, which included non-cash income of $22.5 million reflected in the change in the estimated fair value of acquisition-related contingent consideration, and non-cash charges of $5.1 million for stock-based compensation, and $4.7 million for depreciation and amortization. The Company's operating loss of $35.8 million for the six months ended June 30, 2025 included a non-cash charge of $5.9 million for stock-based compensation, $5.3 million for depreciation and amortization, and $1.2 million for the change in the estimated fair value of acquisition-related contingent consideration.

CONSOLIDATED OTHER INCOME

Other income remained largely flat at $2.9 million for the six months ended June 30, 2026 and 2025.

CONSOLIDATED INCOME TAXES

The Company continues to believe the full valuation allowance established against its total U.S. deferred tax asset is appropriate as the facts and circumstances necessitating the allowance have not changed. The Company has not achieved U.S. cumulative pre-tax earnings based on a rolling three year window as the Company has not achieved a level of sustained profitability that would, in its judgment, support the release of the valuation allowance. For the six months ended June 30, 2026 and 2025, the Company recorded income tax benefit and expense of $0.4 million and $1.5 million, respectively. During the six months ended June 30, 2026 and 2025, the Company had an effective tax rate of 2.5% and (4.7)%, respectively. The increase in the Company's tax rate was primarily due to the recording of a uncertain tax position in 2025 and projected break-even results in foreign operations in 2026 versus projected losses in 2025.

Liquidity and Capital Resources


	June 30, 2026		December 31, 2025
	(in thousands)
Cash and cash equivalents	$	160,582	$	199,278

Working capital	197,818		222,113

The Company's cash and cash equivalents decreased to $160.6 million at June 30, 2026 from $199.3 million at December 31, 2025. The Company has $84.6 million, or 53%, of its $160.6 million of cash and cash equivalents held by DNAG, the Company's Canadian subsidiary.

The Company's working capital decreased to $197.8 million at June 30, 2026 from $222.1 million at December 31, 2025. Working capital is primarily a function of sales, purchase volumes, inventory requirements, and vendor payment terms.

Analysis of the Company's Cash Flows

Operating Activities

During the six months ended June 30, 2026, net cash used in operating activities was $23.8 million. Cash flows from operations can be significantly impacted by factors such as timing of receipts from customers, inventory purchases, and payments to vendors. The Company's net loss of $16.1 million included non-cash charges of a change in the estimated fair value of acquisition-related contingent consideration of $22.5 million, stock-based compensation expense of $5.1 million, depreciation and amortization expense of $4.7 million, a loss on equity investment of $1.6 million, and other non-cash charges aggregating to $0.2 million.

Changes in the Company's working capital accounts contributed to cash and included an increase in accrued expenses and other liabilities of $2.9 million largely associated with higher compensation-related accruals, a decrease in prepaid expenses and other assets of $2.5 million resulting from lower deposits paid, an increase of $1.3 million in accounts payable associated with the timing of spend on consulting services and inventory purchases, and an overall decrease in inventory balances of $0.9 million due to an increase in inventory reserves associated with expired inventory and lower COVID-19 inventory levels due to decreased demand. These contributions to cash were offset by an increase in accounts receivable of $3.7 million due to timing of shipments and invoicing and a decrease in deferred revenue of $0.6 million as work on grant projects is completed and earned.

Investing Activities

Net cash used in investing activities was $3.3 million for the six months ended June 30, 2026, for purchases of property and equipment.

Financing Activities

Net cash used in financing activities was $8.5 million for the six months ended June 30, 2026, which was largely comprised of $7.0 million to repurchase common stock pursuant to the Company's stock repurchase plan and $1.5 million used for the repurchase of common stock to satisfy withholding taxes related to the vesting of restricted stock awarded to the Company's employees.

Resources

The Company's contractual obligations are included in Note 12 of its consolidated financial statements. The Company expects existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements over the next twelve months. The Company's cash requirements, however, may vary materially from those now planned due to many factors, including, but not limited to, the scope and timing of future strategic acquisitions, the progress of its research and development programs, the scope and results of clinical testing, the cost of any future litigation, the magnitude of capital expenditures, changes in existing and potential relationships with business partners, the timing and cost of obtaining regulatory approvals, the timing and cost of future stock purchases, the costs involved in obtaining and enforcing patents, proprietary rights and any necessary licenses, the cost and timing of expansion of sales and marketing activities, market acceptance of new products, competing technological and market developments, the impact of the current economic environment and other factors.

Critical Accounting Policies and Estimates

A more detailed review of the Company's critical accounting policies is contained in its Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC. No material changes have been made to such critical accounting policies during the six months ended June 30, 2026.

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There has been no material change in the Company's assessment of its sensitivity to market risk since its presentation set forth in Item 7A, "Quantitative and Qualitative Disclosures About Market Risk," in its Annual Report on Form 10-K for the year ended December 31, 2025.

Item 4. CONTROLS AND PROCEDURES

(a) Evaluation of Disclosure Controls and Procedures. The Company’s management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934) as of June 30, 2026. Based on that evaluation, the Company’s management, including such officers, concluded that the Company’s disclosure controls and procedures were effective as of June 30, 2026 to provide reasonable assurance that material information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act of 1934 was accumulated and communicated to the Company’s management, including the Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure and was recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission.

(b) Changes in Internal Control Over Financial Reporting. There was no change in the Company’s internal control over financial reporting that occurred during the three months ended June 30, 2026 that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

PART II. OTHER INFORMATION

Item 1. LEGAL PROCEEDINGS

NowDiagnostics Litigation

misappropriation and misuse of the Company's proprietary information and trade secrets by NowDx, Berry and Young in violation of the Federal Defend Trade Secrets Act and the Pennsylvania Uniform Trade Secrets Act. The complaint also alleges breach of contract and duty of loyalty by Young, unfair competition by NowDx, and tortious interference with contractual relations by Berry and NowDx. NowDx filed Counterclaims against the Company on January 13, 2025 and the Company filed its Answer to the Counterclaims on February 3, 2025. Young filed a Motion to Dismiss the claims against her, which was denied by the court on February 4, 2025. NowDx, Berry, and Young agreed to a preliminary injunction which the Court entered on February 27, 2025 and that remains in place. On February 11, 2026, the Court issued an order scheduling trial for January 17, 2027.

Item 1A. RISK FACTORS

There have been no material changes to the risk factors disclosed in Item 1A, entitled “Risk Factors,” in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 9, 2026.

Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS


Period	Total number of shares purchased		Average price paid per share		Total number of shares purchased as part of publicly announced plans or programs	Maximum number (or approximate dollar value) of shares that may yet be repurchased under the plans or programs (1)
April 1, 2026 - April 30, 2026	548,990		$	3.11	548,990	$	18,253,686
May 1, 2026 - May 31, 2026	170,407	(2)	$	3.01	97,808	$	17,960,005
June 1, 2026 - June 30, 2026	844	(2)	$	4.12	—	$	17,960,005
	720,241				646,798

(1)In March 2025, the Company's board of directors authorized a stock repurchase program (the “Repurchase Program”) effective March 21, 2025, whereby the Company may purchase up to $40.0 million in shares of its common stock over a period of up to two years. The amount and timing of share repurchases under the Repurchase Program may be carried out at the discretion of management through various methods in compliance with applicable state and federal securities laws.

(2)Includes shares retired to satisfy minimum tax withholdings, in connection with the vesting of restricted and performance shares, pursuant to the OraSure Technologies, Inc. Stock Award Plan.

Item 3. DEFAULTS UPON SENIOR SECURITIES

None

Item 4. MINE SAFETY DISCLOSURES

Not applicable

Item 5. OTHER INFORMATION

Rule 10b5-1 Trading Plans

The disclosure set forth in Part II - Item 2 above is incorporated herein by reference.

During the three months ended June 30, 2026, none of the Company's directors or officers adopted, amended, or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

Item 6. EXHIBITS


Exhibit Number		Exhibit

3.1		C ertificate of Amendment to Certificate of Incorporation dated June 3, 2026 (incorporated by reference to Exhibit 3.1 to the Company's Current Report on Form 8-K as filed on June 3, 2026 ).

10.1ˆ	10.1	A mended and Restated OraSure Technologies, Inc. 2000 Stock Award Plan (incorporated by reference to Exhibit 10.1 to the Company's Current R e port on Form 8-K as filed on June 3, 2026).

10.2†		C ooperation Agreement, dated April 16, 2026 , by and Betwe e n OraSure Technologies, Inc. and Altai Capital Management, L.P. and Altai Capital Management LLC (incorporated by refer ence to Exh i bit 10.1 to the Company's Current Report on Form 8-K as filed on April 17, 2026).

31.1*		Certification of Carrie Eglinton-Manner required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.

31.2*		Certification of Kenneth J. McGrath required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.

32.1*+		Certification of Carrie Eglinton-Manner required by Rule 13a-14(b) or Rule 15d-14(b) under the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2*+		Certification of Kenneth J. McGrath required by Rule 13a-14(b) or Rule 15d-14(b) under the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS		Inline XBRL Instance Document – the Instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

101.SCH		Inline XBRL Taxonomy Extension Schema Document

101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB		Inline XBRL Taxonomy Extension Labels Linkbase Document

101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document

104		Cover Page from Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in exhibits 101).

*Filed herewith

ˆ Management contract or compensatory plan or arrangement.

† Pursuant to Item 601(a)(5) of Regulation S-K, certain exhibits have been omitted and will be furnished supplementally to the Securities and Exchange Commission upon request.

+ This certification is deemed not filed for purposes of section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.


	ORASURE TECHNOLOGIES, INC.

		/s/ Kenneth J. McGrath
Date: August 7, 2026		Kenneth J. McGrath
		Chief Financial Officer
		(Principal Financial Officer)

		/s/Michele M. Anthony
Date: August 7, 2026		Michele M. Anthony
		Senior Vice President, Controller and Chief Accounting Officer
		(Principal Accounting Officer)