Exact Sciences bags FDA approval and proposed CMS coverage for colorectal cancer screening test

Exact Sciences CEO Kevin Conroy

Exact Sciences ($EXAS) won FDA approval for its stool-based colorectal cancer screening test, charting a regulatory milestone and picking up proposed national coverage for its product along the way.

The Madison, WI-based company is reaping the benefits of a joint pilot program from the FDA and the Centers for Medicare and Medicaid Services (CMS) that allows the agencies to simultaneously review medical devices to reduce time between approval and Medicare coverage. Exact's Cologuard test is the first product to take part in the initiative, scoring regulators' blessings and a proposed coverage memorandum that could pave the way for full Medicare reimbursement. A final coverage determination is expected to be posted later this year after a public comment period, the company said in a statement.

Meanwhile, Exact will offer its test to U.S. healthcare providers for $599. The company plans on working with private insurers to issue coverage decisions for Cologuard and to make its screening test available to more patients over the age of 50 who are at average risk of colorectal cancer, CEO Kevin Conroy told FierceMedicalDevices.

"The goal will be to focus on the largest payers first that cover the most number of lives. In the meantime, patients will be able to get the test and our lab will bill the insurers and negotiate on behalf of the patient to secure reimbursement," Conroy said.

FDA approval for Cologuard is the cherry on top of a good year for Exact, as the company has worked continuously to build momentum for its colorectal cancer test. In March, the company celebrated results from a pivotal trial of Cologuard in 10,000 patients with colorectal cancer. The study, published in The New England Journal of Medicine, showed that the test displayed 92% sensitivity in detecting patients with colorectal cancer, versus 74% for a standard fecal immunochemical test.

Earlier this year, Exact won unanimous FDA panel approval for Cologuard, paving the way for the test's full regulatory clearance. In April, the company raked in nearly $120 million through a stock offering, funds the company planned to use for a final regulatory push and Cologuard's commercial launch.

But Exact Sciences is not the only diagnostics outfit making headway in early-stage colon cancer detection. In March, German company Epigenomics earned a 5-to-4 FDA panel vote for its Epi proColon test. The company bills its diagnostic as the first blood-based polymerase chain reaction IVD test for early detection of colon cancer. In May, Qiagen ($QGEN) inked a companion diagnostics deal with Amgen ($AMGN) to identify patients who would benefit from Vectibix, a first-line treatment for metastatic colorectal cancer.

Exact Sciences shares opened high at $18.50 and peaked at more than $19 but then closed on Tuesday at $17.47.

- here's Exact Sciences' statement
- get more from Xconomy
- here's FierceDiagnostics' take

Special Report: R&D advances in cancer Dx - Exact Sciences

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