BioCentury
ARTICLE | Product Development

Second (Ex)act

Why Exact Sciences expects smooth reimbursement path for its HCC test

June 6, 2018 12:24 AM UTC

Armed with Phase II data for its second DNA methylation test, Exact Sciences Corp. expects a repeat performance of the rapid launch trajectory its Cologuard colorectal cancer screening assay has enjoyed. Cologuard beat expectations for a molecular diagnostic thanks in part to a parallel review that allowed it to launch with a national coverage determination from CMS.

The company isn’t saying whether it expects to get an NCD upon launch of its new hepatocellular carcinoma (HCC) screening test. But it says relationships with payers it has built since launching Cologuard, combined with data suggesting much better performance than standard of care in a population at high risk for HCC should lead to reimbursement at least as fast as Cologuard’s...

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Exact Sciences Corp.