Exact Sciences Corp. (EXAS), a molecular diagnostics company, will announce preliminary, top-line results of its pivotal clinical trial of stool DNA colorectal cancer screening test on Thursday, April 18, 2013, prior to the market open.
In the trial, dubbed DeeP-C study, the accuracy of Exact Sciences' stool DNA colorectal cancer screening test is compared with that of traditional screening methods like colonoscopy and fecal immunochemical test.
The company's colorectal cancer screening test is a non-invasive test that works by identifying DNA changes, caused from cancerous tumors or precancerous polyps, in the cells that are shed from the lining of the colon into the stool. The test also includes a hemoglobin detection component which identifies the presence of blood in the stool, which is another possible indicator of colorectal cancer.
The results of the DeeP-C trial are expected to form the basis of the company's submission to the FDA for pre-market approval of the stool DNA colorectal cancer screening test.
According to the American Cancer Society, colorectal cancer is expected to cause about 50,830 deaths during 2013. Colorectal cancer is said to be the third leading cause of cancer-related deaths in the U.S. when men and women are considered separately, and the second leading cause when both sexes are combined.
Regular screenings are necessary to detect colorectal cancer since the disease hardly shows any symptoms in its early stage. More than 90% of all colorectal cancers are diagnosed after age 50, and therefore it is important for both men and women aged 50 and older to have a colon cancer screening test.
But with 40 percent of adults aged 50 and older in the U.S. not being screened for colorectal cancer, there remains a major unmet need for a new, patient-friendly colorectal cancer screening test, with an estimated potential of over $2 billion, according to Exact Sciences.
Shares of Exact Sciences have thus far hit a 52-week low of $8.87 and a 52-week high of $12.30. The stock closed Wednesday's trading at $9.97, down 2.64%. In extended trading, the stock was up more than 10% at $10.99.
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