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CMS Finalizes NCD for Exact's Cologuard; Issues Preliminary Pricing in Line With Company Proposal

NEW YORK (GenomeWeb) – The Centers for Medicare & Medicaid Services has issued a final National Coverage Determination (NCD) for Exact Sciences' stool DNA colorectal screening test Cologuard, and has agreed with the company's proposal to reimburse testing at $502.

CMS pricing was higher than an estimate of $305 by Mizhuo Securities analyst Peter Lawson and $400 based on an investor survey. While the final coverage determination goes into effect immediately, the test pricing is preliminary. Final pricing from CMS is expected before year end following a comment period.

Exact Sciences' stock soared in Friday morning trade on the Nasdaq, rising 34 percent to $24.23.

"We believe this is a best-case scenario for Cologuard reimbursement," wrote Goldman Sachs analyst Isaac Ro in a note, who had estimated test pricing at $500. He added that the total addressable market for the test is "far bigger than expected." Exact had projected that Cologuard could be marketed to 100 million high and average-risk patients. Back in July, before the test garnered regulatory approval in the US, one analyst had pegged the market size to be closer to 41 million people.

Exact successfully completed the parallel review process, and in August it simultaneously received US Food and Drug Administration regulatory approval for Cologuard and a proposed NCD from CMS. The firm had submitted data to both agencies from the DeeP-C trial, which involved 10,000 patients.

The test is the first FDA-approved and Medicare-reimbursed non-invasive screening test for colorectal cancer that analyzes both stool-based DNA and blood biomarkers to detect cancer and precancer. According to the final NCD, CMS has deemed Cologuard to have sufficient evidence to cover it as a colorectal cancer screening test for asymptomatic, average-risk beneficiaries aged 50 to 85 years.