Rosetta Genomics Receives Approval from New York State for Four PCR-Based Assays
May 23 2016 - 8:00AM
Business Wire
BRAF, EGFR, KRAS and NRAS Mutation Detection
Assays Now Available in all 50 States
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 GenomicsRosetta 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 DisclaimerVarious 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160523005674/en/
Rosetta Genomics:Ken Berlin, 267-298-1159President &
CEOinvestors@rosettagx.comorRosetta Genomics
Investors:LHAAnne Marie Fields,
212-838-3777afields@lhai.com
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