NEW YORK (GenomeWeb News) – Exact Sciences will meet next week with officials from the Centers for Medicare and Medicaid Services to discuss the status of CMS’ review of the firm’s colorectal cancer screening technology, the company said today.
The company applied last August for a national coverage determination with CMS to try to get the stool-based CRC diagnostic covered under Medicare, but in October it was notified by the US Food and Drug Administration that the PreGen-Plus assay would require premarket approval.
"We have advised CMS of the status of our discussions with the FDA and, in an effort to preserve our future opportunity for a positive coverage decision, we requested that it consider not proceeding with the NCD until the FDA has acted," Exact Sciences President Jeffrey Luber said in a statement.
“We look forward to meeting with CMS to better understand its likely approach while we pursue FDA clearance for our DNA-based colorectal cancer screening technology," he added.
In October, the FDA’s Office of In Vitro Diagnostics Device Evaluation and Safety told Exact Sciences that it would need to review the PreGen-Plus because it deemed the test to be a medical device that required oversight and approval.
Exact Sciences did not provide an update today on the FDA’s review and company officials were not immediately available for comment.