UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On May 23, 2024, Guardant Health, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration’s (the “FDA”) Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee has strongly recommended FDA approval of the Company’s Shield blood test to screen for colorectal cancer in adults age 45 and older who are at average risk for the disease.
The advisory committee panel members voted on three questions regarding the use of Shield in patients who meet the criteria specified in the proposed indication. They voted 8 to 1 favorably that there is reasonable assurance Shield is safe, 6 to 3 favorably that there is reasonable assurance Shield is effective, and 7 to 2 favorably that the benefits of Shield outweigh its risks.
The recommendation from the Advisory Committee will be considered by the FDA during its ongoing review of the premarket approval for the Shield blood test.
A copy of the press release is being filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press release of Guardant Health, Inc., dated May 23, 2024. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| GUARDANT HEALTH, INC. | ||||||
| Date: May 24, 2024 | By: | /s/ John G. Saia | ||||
| John G. Saia | ||||||
| Chief Legal Officer and Corporate Secretary | ||||||