Colorectal Cancer Test Gets AdComm OK as Primary Screening Tool

While Shield, Guardant’s blood-based colorectal cancer screening test, got an overall thumbs-up from an FDA advisory committee, members stressed that it’s no substitute for colonoscopy.

The nine-member committee supported Shield’s safety by 8-1, its effectiveness by 6-3 and its benefit-risk profile by 7-2.

“The data show that colonoscopy is clearly superior, and I don't think Guardant would argue with that,” said Charity Morgan, a biostatistician from the University of Alabama at Birmingham. “But [while] it's better than nothing for people who are going to get nothing, it's not better than colonoscopy.”

Guardant intends to market the test as a non-invasive alternative for patients who can’t access -- or refuse -- screening colonoscopy. A negative test would put them in a retest cycle of 1-3 years; a positive test would require colonoscopy follow up.

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