In a scene worthy of a medical drama, advisers to the U.S. Food and Drug Administration cast a crucial vote on Thursday, leaning 7-to-2 in favor of Guardant Health’s (NASDAQ:GH) blood test, Shield, for detecting colorectal cancer (CRC).
The FDA is expected to render its verdict on Shield later this year, with Guardant Health eagerly waiting for the green light. Should Shield receive approval, it will join the elite ranks of blood-based CRC tests, becoming only the second of its kind in the U.S. after Epigenomics’ Epi proColon, which debuted in 2016.
Guardant co-CEO AmirAli Talasaz hailed the advisory committee’s vote, saying it underscores the importance of offering a blood test to boost CRC screening rates among those at average risk.
CRC is no small fry, affecting around 150,000 Americans annually and ranking as the second-deadliest cancer in the country, claiming over 50,000 lives each year, according to the FDA.
While colonoscopy reigns supreme as the gold standard for colon cancer detection, its invasive nature makes it a hard sell. Alternatives like Exact Sciences’ (NASDAQ:EXAS) Cologuard, a fecal test, are available, but blood tests are seen as a more user-friendly option.
However, not all was rosy at the meeting. Panelists expressed concerns over Shield’s accuracy, noting it detected a mere 13% of precancerous tumors, known as advanced adenomas. FDA staff had flagged this issue in their briefing documents released earlier in the week.
Guardant’s Shield showed an 83% detection rate for colorectal cancers in studies, trailing behind Cologuard’s 92.3% sensitivity. “It’s better than nothing, but I don’t want to downplay the issue that this test is going to miss a lot of cancers,” said panel member Charity Morgan, a biostatistics professor at the University of Alabama.
Guardant Health executive Victoria Raymond acknowledged that Shield would need to be repeated every one to three years, but emphasized that “colonoscopy should be the prioritized option.”
Trading in Guardant Health shares was put on ice Thursday, adding a layer of suspense to the day’s events.