PHILADELPHIA & REHOVOT, Israel--(BUSINESS WIRE)--Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and provider of microRNA-based and other molecular diagnostic testing services, announces 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 155 million 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.
About 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. In addition, the Company offers core FISH, IHC and
PCR-based testing capabilities in Pathology, Oncology and Urology that
provide additional content and platforms that complement Rosetta’s
microRNA and Next-Gen Sequencing offerings. RosettaGX Reveal™, a Thyroid
microRNA Classifier for the diagnosis of indeterminate thyroid FNA
smears, as well as the full RosettaGX™ portfolio of cancer testing
services are commercially available through the Company’s Philadelphia,
PA- and Lake Forest, CA-based CAP-accredited, CLIA-certified labs. For
more information visit www.rosettagx.com.
Forward-Looking Statement Disclaimer
Various statements in
this release concerning Rosetta’s future expectations, plans and
prospects including, but not limited to statements relating to our
receipt of final approval from the NYSDOH, health and economic benefits
to physicians and patients, and enhanced adoption of Rosetta assays in
the marketplace constitute forward-looking statements for the purposes
of the safe harbor provisions under The Private Securities Litigation
Reform Act of 1995. Actual results may differ materially from those
indicated by these forward-looking statements as a result of various
important factors, including those risks more fully discussed in the
"Risk Factors" section of Rosetta’s most recently filed Annual Report on
Form 20-F, as filed with the SEC. In addition, any forward-looking
statements represent Rosetta’s views only as of the date of this release
and should not be relied upon as representing its views as of any
subsequent date. Rosetta does not assume any obligation to update any
forward-looking statements unless required by law.