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Medicare Contractor Confirms Coverage for One Rosetta Genomics Test, Denies Coverage for Two Others

NEW YORK (GenomeWeb News) – A Medicare contractor has issued a final coverage determination confirming coverage for one of Rosetta Genomics' microRNA-based cancer diagnostics, but denying Medicare coverage for two of the firm's other tests, Rosetta announced today.

In a final revised local coverage determination for Biomarkers in Oncology, Novitas Solutions — the designated Medicare administrative contractor for Rosetta's assays — confirmed continued coverage for Rosetta's Cancer Origin Test for identifying cancer of unknown or uncertain primary, or CUP. Novitas originally reported a coverage determination last year and Medicare has been reimbursing $3,500 for the test.

The determination becomes effective on Aug. 1.

In a statement, Rosetta President and CEO Kenneth Berlin said Novitas' determination "affirms that our test is reasonable and necessary for providing an important niche in the pathologic diagnoses of CUP. With more than 200,000 patients per year presenting with cancer of unknown or uncertain primary, and who may benefit from our Cancer Origin Test, this coverage reflects the importance of determining the tumor origin in hard-to-diagnose metastatic cancers and CUP. This is particularly important as new, molecularly targeted cancer treatments are developed."

However, Rosetta also reported that Novitas continues to view the company's Lung Cancer Test and the Kidney Cancer Test as investigational, and Medicare will not reimburse for those two tests. The tests were formerly called the miRview mets2 lung and kidney assays.

"We continue to build the body of clinical data in support of the utility of our Lung Cancer Test and our Kidney Cancer Test in sub-classifying tumor types," Berlin said. "We believe that additional clinical data and peer-reviewed publications will support a favorable reimbursement decision for these tests in the future."

In afternoon trading on the Nasdaq, shares of Rosetta were up more than 6 percent at $4.07.

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