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New York State Clears Rosetta Genomics' Array-based Cancer of Unknown Primary Test

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Rosetta Genomics said last week that the New York State Department of Health has cleared its miRview mets2 diagnostic for testing on patient samples from the state.

Rosetta Genomics' miRview mets2 relies on a panel of 64 microRNA markers to distinguish 42 different tumor types for patients suffering from cancer whose primary origin is uncertain. Rehovot, Israel-based Rosetta Genomics launched the array-based test through its Clinical Laboratory Improvement Act-compliant facility in Philadelphia last year (BAN 3/23/2011).

New York is the only US state that requires an independent regulatory review process for laboratory-developed tests. With this approval, Rosetta Genomics said it can now offer miRview Mets2 in every US state.

CEO Kenneth Berlin said in a statement that there are about 200,000 cases of cancer of unknown primary in the US each year, and that there is a "pressing clinical need" for a test that can accurately identify the tumor of origin.

Rosetta Genomics earlier this year discussed a post-marketing validation study of the test, which showed that it exhibited 88 percent concordance with clinical presentation and pathology on a set of cancer-of-unknown-primary samples, exceeding the accuracy of its predecessor PCR-based assay, miRview mets (BAN 6/28/2011).

At the time, Rosetta also disclosed additional results showing that miRview Mets2 can be successfully performed on calcified bone, a common site for metastatic cancer.

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