It was all smiles and congratulatory handshakes for Exact Sciences president and CEO Kevin Conroy this afternoon after a panel of physicians and medical experts unanimously endorsed the Madison, WI-based company’s colon cancer screening test for FDA approval.
The FDA advisory committee voted 10-0 on all three questions, indicating panelists’ belief that Cologuard—Exact’s non-invasive, stool DNA-based test for colorectal cancer—is safe, effective, and the benefits outweigh the risks.
The committee’s vote continues the positive momentum for Exact (NASDAQ: EXAS) following last week’s publication of the full results of the peer-reviewed study of Cologuard in the New England Journal of Medicine. The vote doesn’t mean FDA approval is a done deal, but the agency will take the panel’s discussion and recommendation into consideration when it makes a final decision.
“I think this is a very impressive study with very positive conclusions,” said advisory committee member Steven Skates, of Massachusetts General Hospital in Boston. “This is one of the biggest improvements in early detection [of colorectal cancer] that I’ve seen.”
The all-day meeting adjourned at 3:20 p.m. Eastern time, one hour and 40 minutes ahead of schedule, reflecting panelists’ lack of significant qualms with the study. At several points during the discussion, which Xconomy followed via webcast, panelists commended Exact for the thoroughness of the trial, which involved more than 10,000 patients at 90 healthcare centers nationwide. Panelists also praised Cologuard’s positive results that showed marked improvements in detecting colorectal cancer over the fecal immunochemical test (FIT), a commonly used, non-invasive colorectal cancer screener.
Skates and others did question the fact that Cologuard generated more false positives than FIT in the study. But after FDA officials gave their in-depth evaluation of the data, Skates said his concerns were alleviated because the tradeoff between sensitivity and specificity was “balanced and completely justified.”
Questions were also raised about … Next Page »