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Rosetta Genomics Gets Conditional Approval for Cancer Mutation Assays in NY State

NEW YORK (GenomeWeb) – Rosetta Genomics announced today that it has received conditional approval from the New York State Department of Health (NYSDOH) for its allele-specific PCR-based assays designed to test for BRAF, EGFR, KRAS, and NRAS mutations in lung, colon, and melanoma cancers.

While the four assays are CLIA certified, Rosetta said that that it requires additional licenses from the NYSDOH to offer the tests in the state. The company can now do so, but is required to provide any additional information requested by the agency within 60 days in order to receive final approval.

In February, Rosetta received conditional approval from the NYSDOH for the RosettaGX Reveal thyroid cancer diagnostic assay. And last August, it got NYSDOH clearance for its fluorescence in situ hybridization-based ROS1 lung cancer biomarker assay.