US FDA staff says Guardant's test may fail to detect some pre-cancerous tumors

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S.

(Reuters) -The U.S. Food and Drug Administration's staff reviewers on Tuesday raised concerns that Guardant Health's blood test for a cancer of colon or rectum may fail to detect some types of tumors that can later become cancerous.

The reviewers, however, said the test may increase compliance with screening for colorectal cancer and help detect it in earlier stages, potentially helping cure patients and prolong survival.

Shares of the company fell 2.5% in the afternoon.

The comments come ahead of the FDA's meeting with outside advisers on Thursday. While the FDA typically takes decisions based on the advisers' recommendations, it is not obligated to do so.

If approved, the test, Shield, could become the second blood-based colorectal cancer test in the U.S.

Colorectal cancer occurs in about 150,000 patients in the U.S. annually and leads to more than 50,000 deaths each year, the FDA said.

Screening for colorectal cancer is a nearly $20 billion market in the U.S., and despite material progress, 60 million individuals remain unscreened, TD Cowen analyst Dan Brennan had written in a note in March.

Guardant's application for Shield was based on a study, which showed that the test detected 83% of colorectal cancers and 13% of advanced adenomas, the pre-cancerous tumors.

The low performance of detecting advanced adenomas could be in focus during the meeting and "it appears that FDA is seeking mitigation strategies" for it, Leerink Partners analyst Puneet Souda wrote in a note.

The U.S. Centers for Medicare and Medicaid Services, according to its guidelines, reimburses blood-based colorectal cancer tests with a minimum sensitivity of 74%, if they are approved by the FDA.

Epigenomics' Epi proColon was the first such test to get FDA approval in 2016, but was rejected for reimbursement by the CMS in 2021 due to its 68.2% sensitivity.

Epigenomics was bought by New Day Diagnostics last year and the test was renamed ColoHealth.

(Reporting by Puyaan Singh and Leroy Leo in Bengaluru; Editing by Sriraj Kalluvila and Shilpi Majumdar)