FDA panel backs Guardant’s colorectal cancer blood test for favorable risk-benefit

Key takeaways:

• FDA panel voted 8 to1 in favor of approval for Guardant Health’s blood test for colorectal cancer, citing reasonable safety and efficacy.
• Advisors reported that benefits of the blood test “outweigh the risks.”

An FDA advisory committee has voted strongly in favor of approval for Guardant Health’s blood test for colorectal cancer, intended for patients aged 45 years and older at average risk for disease.

The Molecular and Clinical Genetics Panel of the FDA’s Medical Devices Advisory Committee voted 8 to 1 that there was reasonable assurance that Guardant Health’s Shield blood test is safe, 7 to 2 that the benefits of Shield outweigh the risks and 6 to 3 that there was reasonable assurance that Shield is effective.

“The advisory committee’s strong support for the approval of Shield reinforces the crucial role that a blood test option can have in improving CRC screening rates for those at average risk,” AmirAli Talasaz, co-CEO of Guardant Health, said in a company press release. “Despite the importance of detecting colorectal cancer early, there are notable barriers that can deter average-risk Americans from completing existing screening methods. Shield effectively detects cancer at an early stage when it is most treatable. Providing people with this blood test alongside other non-invasive stool tests can increase the rate of colorectal screening and potentially reduce preventable CRC deaths.”

The panel based their decision on evidence from Guardant’s premarket approval application as well as results from the ECLIPSE trial, a prospective registrational study that compared the Shield test against screening colonoscopy in average-risk adults aged 45 to 84 years from sites across the United States.

Results of the ECLIPSE trial, published in The New England Journal of Medicine, reported that the Shield blood test demonstrated 83% sensitivity for colorectal cancer, 90% specificity for advanced neoplasia and 13% sensitivity for advanced precancerous lesions.

“Sadly, 76% of deaths caused by colorectal cancer occur in individuals who are not up to date with their screening,” Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and professor of medicine at Harvard Medical School, said in the release. “Clinical evidence and CRC screening guidelines acknowledge the value of offering choice to individuals at average risk for CRC and highlight the role of patient preference in test selection and CRC screening completion.”

Guardant emphasized that the FDA’s panel favorable recommendation of Shield’s safety and effectiveness aligns with the test’s intended use, and welcomed the panel’s “conclusion that its benefits as a primary non-invasive screening option outweigh any potential risks.”

The FDA is not required to follow the recommendations of its advisory panels, but it usually does, with an official FDA decision expected later this year.

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