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After Medicare Nod for CUP Diagnostic, Rosetta Aims to Get Coverage for Other miRNA Tests

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Having just obtained Medicare coverage for its flagship microRNA-based diagnostic, Rosetta Genomics is gearing up to submit additional information to Medicare administrative contractor Novitas in hopes of getting reimbursement approval for its other miRNA tests, Gene Silencing News has learned.

Last week, Rosetta announced that Novitas would fully cover the miRview Mets 2 test for all Medicare beneficiaries in the US, marking the first time the company has gotten such coverage for any of its diagnostics (GSN 5/17/2012).

By analyzing the expression pattern of 64 miRNAs, the assay is designed to identify the source of tumors of unknown or uncertain primary origin. According to Rosetta, miRview Mets 2 can differentiate 42 different tumor types with an overall sensitivity of 85 percent and overall specificity of 99.3 percent.

Launched in late 2010, the test is part of a portfolio of five other miRNA diagnostics, which includes a first-generation version of miRview Mets; miRview Lung for the differentiation of lung primary tumors; miRview Squamous for the differentiation of squamous from non-squamous non-small cell lung cancer; miRview Meso for the differentiation of malignant pleural mesothelioma from carcinomas in the lung and pleura; and the newly introduced miRview Kidney for the differentiation of the main histological types of primary kidney tumors.

According to Rosetta President and CEO Kenneth Berlin, data that the company submitted to Novitas on miRview Mets 2 was well received, sufficiently establishing the medical necessity of the information the test could provide a clinician and garnering the reimbursement approval.

“Aside from getting a product on the market … [obtaining Medicare coverage] is the single most important event that can happen for a lab,” Berlin told Gene Silencing News.

“In cancer, in particular, Medicare patients represent a large percent of the population of patients who would be eligible for your test,” he said. Without coverage, doctors are less likely to order a test because they “don't want their patients to come back to them and say, 'Why did you order this several thousand dollar test on me and … my insurance isn't picking it up?'”

Knowledge that a test is covered, he noted, “takes away one of the key barriers for adoption.”

At the same time, private payors often take cues from Medicare, Berlin added. As such, the Novitas decision is expected to prompt other insurance companies to begin covering miRview Mets 2.

Taken together, these developments are critically important to a company like Rosetta, which is “just starting to walk up the revenue curve,” he said.

Indeed, Rosetta has thus encountered difficulties in selling its line of miRNA diagnostics, posting 2011 revenues of just $103,000, down from $279,000 the year before. But while Berlin said the Medicare coverage of miRview Mets 2 is expected to help boost these numbers, he declined to provide any specific revenue guidance.

He also did not give any indication as to when Rosetta's other diagnostics may get the reimbursement green light from Novitas, but said that the payor has already asked for information on the other tests.

And while miRview Mets 2 is the company's “most complicated test,” Berlin cautioned that the other miRview offerings may not necessarily face a shorter path toward Medicare coverage.

“You've [still] got to show they are important medically,” he said. “At the end of the day, [payors] don't want to be paying for tests that don't help in care pathways. If the test just gives additional information that the doctor isn't going to use, they don't want to pay for that.”

“You've got to show there is clinical utility for the test,” he said.

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