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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One response to “Exact Sciences’ Colon Cancer Test Clears Key Hurdle, FDA Next”

  1. Nice article. I think people are missing something Kevin brought up on the call about the false positives. Only 37% of them were in patients with clean colons. 23% were from people with hyperplastic polyps, and 40% were from people with non advanced adenomas (smaller than 1cm). In my opinion, finding non advanced adenomas and removing them really early is a really good thing. And both people with hyperplastic polyps and non advanced adenomas may be recommended by their doctor for more frequent colonoscopy to monitor.

    Of the people with clean colons, I am very interested to find out what kind of follow up could or will be done. If one looks into Ahlquist’s patents, it is known that cancers upstream in the GI Tract shared some DNA markers with CRC. Could it be, that some of the “clean colon” false positives had something detected from higher up the GI Tract? I would hope these folks are being followed up with over the next decade at regular intervals. Also hope they didn’t have a flat lesion that the Colonoscopy missed.