FDA Panel Gives Exact’s Colon Cancer Test Ringing Endorsement

Xconomy Wisconsin — 

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 quality control and product labeling. After all, Cologuard will require patients to take a sample of their stool at home and ship it to a lab for testing.

“How clear are the directions on the labels? Are they simple enough for people to follow?” asked Jo-Ellen De Luca, a non-voting panel member representing patients. She runs Colon Cancer Solutions, a nonprofit based in Spartanburg, SC.

The Cologuard labels were originally written for a seventh grade reading level, and the instructions were revised after the clinical trial so that people with a lower reading comprehension would be able to follow the directions, said Sandra Statz, Exact’s vice president focused on clinical, quality, and regulatory issues. The company has also made minor tweaks to its collection containers to decrease leakage, she said.

Much of the discussion focused on the design of a follow-up study, which Exact has proposed would test Cologuard’s performance in 1,830 patients in at least 20 clinical sites. Exact’s proposal would have patients take an initial Cologuard test. If that came back positive, they would undergo a colonoscopy. If it came back negative, they would perform a repeat Cologuard test three years later.

But some panelists suggested the follow-up study could also involve an FIT test, and that Exact might consider running the Cologuard test on patients annually in the study, instead of only at the outset and again three years later. FIT, for example, is recommended as an annual test.

Skates admitted more frequent testing would add costs to healthcare providers and patients. But the results might definitively show whether such testing will provide meaningful—or just marginal—improvements to patient health, he said.

“What an annual study will be able to provide is, what is that tradeoff?” Skates said. “The conclusion at the end could very well be that [Cologuard testing] every three years is sufficient.”