NEW YORK (GenomeWeb News) – Rosetta Genomics today said that the New York State Department of Health has granted the firm approval to begin processing patient samples from the state for its miRview mets^2 test.
New York requires providers of laboratory-developed tests to receive approval from the state to process samples from patients within the state. It's the only state in the union to require that independent regulatory review process.
Rosetta's miRview mets^2 test is a microRNA-based assay that identifies the primary origin of tumors that have an uncertain unknown origin. It offers a panel of 42 identifiable tumor origins. In a study of 509 samples the test provided an accurate result in 85 percent of the samples, and in 82 percent of the cases a single tissue of origin prediction was given with an accuracy of 90 percent, said Rehovot, Israel-based Rosetta.
"With approximately 200,000 cases of cancer of unknown primary (CUP) and difficult to diagnose metastatic cancer per year in the US, there is a pressing clinical need for more accurate identification of the tumor of origin," Kenneth Berlin, president and CEO of Rosetta Genomics, said in a statement.