Guardant Health Gets FDA Panel Recommendation for Cancer-Screening Blood Test
By Ben Glickman
Guardant Health said late Thursday that a regulatory advisory panel had recommended the approval of the company's blood test for cancer screening.
The Palo Alto, Calif.-based diagnostics company said that a panel of the U.S. Food and Drug Administration's Medical Devices Advisory Committee "strongly recommended" regulators approve Guardant's Shield test for colorectal-cancer screening, specifically in adults age 45 and up who are at average risk for disease.
The FDA is expected to make a decision on the product later this year.
Guardant Health shares were temporarily halted Thursday morning as the panel reviewed the company's premarket approval application.
Write to Ben Glickman at ben.glickman@wsj.com
(END) Dow Jones Newswires
May 23, 2024 19:40 ET (23:40 GMT)
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