Breakthrough: Cologuard, the Madison, WI, company's stool-based molecular diagnostic, is designed to detect early-stage colorectal cancer by screening for 11 different biomarkers that identify precancerous materials.
Background: Exact Sciences ($EXAS) can be bullish about pivotal trial results released in October involving more than 1,000 patient stool samples, in patients before colonoscopy being screened for early signs of cancer. As well, researchers screened patients 7 days after a colonoscopy who were found to have large precancers or colorectal tumors. The test was effective enough to pick up 98% of cancers and between 50% to 83% of precancers. A 12,700-patient trial is now under way to confirm those results.
Significance: Colon cancer is hard to detect and often isn't found until it is fairly advanced. Detecting tumors on the early side gives patients the best possible chance for successful treatment and tumor removal. Another diagnostic tool is another weapon that can make early colon cancer detection more likely.
Next steps: Exact Sciences filed part one of its premarket application with the FDA in December, submitting manufacturing and quality-control information. Two other PMA modules are expected in the coming weeks that will include analytical and clinical data. The company also had some success going public in August, raising $57.8 million based on anticipation over Cologuard.
Exact Sciences heads to the FDA with cancer diagnostic