Rosetta Genomics Ltd. has announced 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 or remission 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. “We are delighted to be able to service clients across the State of New York with a full FISH menu for liquid tumor analysis, thus allowing them to better determine appropriate treatment options for their patients with hematologic cancers," 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 155 million in the U.S. Our recognized expertise in FISH and our growing menu of tests serving the hematology-oncology and pathology markets will help strengthen our position with leading managed care plans as a provider of choice for high-quality FISH testing and should enhance our goal to sign additional participation agreements during the second half of 2016,” added Mr. Berlin.