Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Videos
Diagnostics
In Vitro Diagnostics
Return to: MDBR Home | Diagnostics | In Vitro Diagnostics

Rosetta Genomics receives approval from New York State for HEME FISH-based assays

MDBR Staff Writer Published 22 June 2016

Rosetta Genomics announces receipt of conditional approval from the New York State Department of Health (NYSDOH) for its 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.

Rosetta develops and commercializes a full range of microRNA-based and other molecular diagnostics. Rosetta's integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs.

Building on its strong patent position and proprietary platform technologies, Rosetta is working on the application of these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools.



Source: Company Press Release