U.S. FDA advisers back approval for Guardant's blood-based cancer test (updated)

Natera

23/05/2024 21:44

(Adds background in paragraphs 3 and 4)
       May 23 (Reuters) - Advisers to the U.S. Food and Drug
Administration on Thursday recommended for the approval of
Guardant Health's  GH.O  blood test to detect a cancer that
begins in the colon or rectum. 
    The panel voted seven-to-two in favor of benefits
outweighing risks when using the test called Shield for
colorectal cancer (CRC).
    If approved, Shield could become the second blood-based test
for CRC diagnosis in the United States after Epigenomics' Epi
proColon, which was approved by in 2016.
    CRC occurs in about 150,000 patients in the U.S. annually
and is the second-leading cause of cancer fatalities in the
country, with more than 50,000 deaths each year, according to
the FDA.

 (Reporting by Puyaan Singh and Leroy Leo in Bengaluru; Editing
by Arun Koyyur)
 ((Puyaan.Singh@thomsonreuters.com;))