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Data from Exact Sciences' Clinical Trial Sends Stock Plunging

NEW YORK (GenomeWeb News) – Shares of Exact Sciences today fell as much as 30 percent after the company announced top-line data from a pivotal clinical trial for its colorectal cancer screening test.

Amid heavy trading, shares of the Madison, Wis.-based firm dipped to as low as $6.93 from Wednesday's closing price of $9.97, after results from the trial, called DeeP-C, failed to meet some internal targets.

Exact said in a statement that the test, called Cologuard, "met or exceeded all primary and secondary endpoints" in the study. The principal investigator on the trial, Thomas Imperiale, called the trial data "very promising. Cologuard may well be a future solution for identifying slow-growing polyps much before they develop into cancer."

Imperiale is a professor of medicine and associate director for research for the division of gastroenterology at Indiana University School of Medicine and a member of the IU Simon Cancer Center.

In the trial of 10,000 patients between the ages of 50 and 84 who were at average risk for colorectal cancer, Cologuard achieved 92 percent sensitivity for the detection of colorectal cancer and 42 percent sensitivity for the detection of precancerous polyps, including 66 percent sensitivity for polyps equal to or greater than 2 centimeters. Specificity for the test was 87 percent.

Mizuho Securities analyst Peter Lawson said in a research note that while Cologuard met Exact's internal goal of 85 percent sensitivity for the detection of colorectal cancer, its 87 percent specificity fell short of an internal goal of 90 percent. The 42 percent sensitivity for precancerous polyps also failed to meet an internal target of 50 percent.

However, Lawson noted that at 42 percent, Cologuard is still "superior to existing test methods such as [fecal immunochemical testing] or [fecal occult blood testing], which generally show precancer sensitivity in the 10-20 percent range."

Lawson added that the internal goals were set by Exact's management and aren't endpoints required for US Food and Drug Administration approval. "Management doesn't see the data affecting commercialization, reimbursement, pricing, or impacting the FDA decision, which was looking for non-inferiority to existing methods such as colonoscopy, FIT, and FOBT," Lawson wrote.

"We are extremely pleased with these results, which we believe strongly support the power and potential clinical use of the Cologuard screening test," Exact Sciences President and CEO Kevin Conroy said in the firm's statement.

Exact will submit data from the DeeP-C study as part of its premarket approval application to FDA. The company submitted the first module of the PMA submission in December and its second module in February. Exact has said it anticipates submitting the third module, which will contain clinical data from the company's DeeP-C trial, in May.

The firm plans on submitting Deep-C's complete dataset for publication in a peer-reviewed journal later this year, it said.

In afternoon trading on the Nasdaq, shares of Exact were down 11 percent to $8.90. More than 20 million shares of the company's stock exchanged hands, or 30 times the average daily volume of Exact trades during the past three months.

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