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Rosetta FISH Cancer Assays Receive NY Department of Health Clearance

NEW YORK (GenomeWeb) – Rosetta Genomics announced today that it has received conditional approval from the New York State Department of Health (NYSDOH) for certain of its multiple fluorescence in situ hybridization (FISH) cancer tests.

According to the company, the conditional approval covers its FISH tests for detecting DNA amplifications or rearrangements in various hematologic cancers in order to form a diagnosis and/or to evaluate prognosis or remission of disease. 

While the tests are performed at a CLIA-certified laboratory, additional licenses from the NYSDOH are required to offer the tests in New York. 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 May, Rosetta received conditional approval from the NYSDOH for its allele-specific PCR-based assays designed to test for BRAF, EGFR, KRAS, and NRAS mutations in lung, colon, and melanoma cancers. It has also recently received NYSDOH clearance for the RosettaGX Reveal thyroid cancer diagnostic assay and its FISH-based ROS1 lung cancer biomarker assay.