Rosetta Receives Approval from NY State for Four PCR-Based Assays
News May 24, 2016
Rosetta Genomics has announced receipt of conditional approval from the New York State Department of Health (NYSDOH) for the Company’s allele-specific PCR (CAST PCR)-based assays to test for BRAF, EGFR, KRAS and NRAS mutations in lung, colon and melanoma cancers. NYSDOH approval was granted under the Company’s Molecular Oncology and Cellular Tumor Marker permit.
These four assays are CLIA certified, yet New York requires an additional license from the NYSDOH for CLIA-certified tests 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.
“We are delighted to be able to service clients across the State of New York with a full molecular menu for solid tumor analysis, thus allowing them to better determine appropriate treatment options for their cancer patients," stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.
“In addition to this expanded geographic access, recent managed care contracting initiatives have resulted in covered lives for these tests exceeding 155million in the U.S. These increases in access, along with the potential health and economic benefits of identifying specific mutations in lung, colon and melanoma cancers should help inform physician treatment decisions and enhance adoption into this multimillion-dollar market,” added Mr. Berlin.