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Rosetta Genomics Receives Approval from New York State for BRAF, EGFR, KRAS and NRAS Mutation Detection Assays

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Additional Relevant Details Rosetta Genomics Ltd. (NASDAQ: ROSG) announces receipt of conditional approval from the New York State Department of Health (NYSDOH) for the Company’s multiple fluorescence in situ hybridization (FISH) tests for detection of amplifications or rearrangements of DNA in a number of hematologic cancers, such as leukemias, lymphomas and myelomas in order to form a diagnosis and/or to evaluate prognosis orremission of disease. NYSDOH approval was granted under the Company’s Molecular Oncology and Cellular Tumor Marker permit.The laboratory is CLIA certified and CAP accredited, yet New York requires an additional permit for each test from the NYSDOH for them to be offered to patients in the state. The NYSDOH also requires the Company to provide any additional information requested within 60 business days for final approval. With this conditional approval, these assays are now available in all 50 states.
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Catalyst Date
Occurred on:
Jun 21, 2016
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Related Keywords Heme Fish-based Assays, Clia Certified