Exact Sciences’ Colon Cancer Test Clears Key Hurdle, FDA Next

Wall Street was pleased today with the newly published results of a pivotal study of Exact Sciences’ non-invasive screening test for colorectal cancer. Next step for the Madison, WI, company: FDA approval.

Exact (NASDAQ: EXAS) announced top-line data of its 10,000-patient study in April 2013, but the full results were officially published Wednesday in a peer-reviewed study in the New England Journal of Medicine (NEJM).

The “Deep-C” study, which took place at 90 healthcare centers throughout the U.S. and Canada, found that Exact’s Cologuard—a stool DNA-based screening test—was much more reliable at detecting colorectal cancer than the fecal immunochemical test (FIT), a commonly used, non-invasive colorectal cancer screener. But Cologuard also resulted in more false positives than FIT.

Exact intended to announce the details of the NEJM study after stock market close today, but a study collaborator accidentally released the data on Tuesday. That inadvertent misstep, reportedly by the Mayo Clinic, drove Exact’s stock price higher during regular and after-hours trading Tuesday, according to SeekingAlpha.com. The next day, Exact’s stock opened at $15.50 per share and rose as high as $15.60 per share, up from the $14.42 per share close on Tuesday. It closed at $14.45 per share today.

Next week, Exact faces an even more important test: An FDA panel is scheduled to review the company’s pre-market approval application.

“We are quite pleased with the results of the Deep-C study, and we look forward to discussing it with our [FDA] advisory committee next week,” Exact president and CEO Kevin Conroy said today in a conference call with investor analysts.

A few key data points from the study:

—Cologuard detected colorectal cancer 92 percent of the time, compared with 74 percent for FIT.

—Cologuard detected advanced pre-cancerous lesions 42 percent of the time, versus 24 percent for FIT.

—Cologuard detected polyps with high-grade dysplasia 69 percent of the time, compared with 46 percent for FIT.

—About 10 percent of study patients received a positive Cologuard result, but no cancer was subsequently found with a colonoscopy. That false positive rate was higher than FIT’s, which was about 4 percent.

Exact Sciences officials and study co-authors don’t appear to be overly concerned with … Next Page »

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Jeff Engel is a senior editor at Xconomy. Email: jengel@xconomy.com Follow @JeffEngelXcon

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