Fresh off some promising data for its stool-based cancer diagnostic, Exact Sciences ($EXAS) is knocking on the FDA's door for full approval, filing part one of a three-step PMA for the assay.
Exact has filed all of its documentation related to manufacturing and quality control of Cologuard and will submit its analytical and clinical data next. Just how long the process will take remains unknown, and the company didn't respond to an email asking for more information Tuesday morning.
The diagnostic is designed to detect changes in DNA from stool samples to identify the early signs of colorectal cancer, using 11 biomarkers to screen for precancerous materials. In a study of about 1,000 patients, Exact's test identified 98% of colorectal cancers and 83% of precancers, and the company is in the midst of a 12,700-patient trial to confirm those results, planning to use the trial's data in its next PMA step.
Exact went public back in August, pulling in about $57.8 million on the promise of Cologuard's potential. CEO Kevin Conroy has said Exact is building up a war chest so that it can hit the ground running once the test is ready for the market.
- read Exact's release