Rosetta Genomics Receives Conditional Approval from New York State for Lung Biomarker
August 06 2015 - 9:00AM
Business Wire
Provides comprehensive profile of biomarkers
in lung cancer
Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and
provider of microRNA-based and other molecular diagnostics,
announces that the Company was granted conditional approval status
for its ROS1 lung cancer biomarker by Fluorescence in situ
Hybridization (FISH) assay from the New York State Department of
Health (“NYSDOH”) under the Company’s Molecular Oncology permit.
New York is the only U.S. state that requires an independent
regulatory review process for laboratory-developed tests. With this
conditional approval, Rosetta Genomics’ ROS1 by FISH assay is now
available in all 50 states. In making the assay available pending
final approval, the NYSDOH requires the Company to provide any
additional information they request within 60 business days.
“Through our recent acquisition of PersonalizeDx, we have a
best-in-class FISH testing program that provides informative FISH
results in 98% of cases with a rapid turnaround time of 3-4 days.
Combining the ROS1 lung cancer biomarker with FDA-approved ALK FISH
and EGFR PCR testing provides actionable genomic targets, which
enhances the oncologist’s treatment decision options,” stated
Kenneth A. Berlin, President and Chief Executive Officer of Rosetta
Genomics.
Rosetta Genomics offers a comprehensive test menu in lung
cancer. Treating physicians have an array of options to choose
from, whether they want to confirm primary lung cancer diagnosis,
clarify tumor subtype, perform a full oncogenomic profile or focus
exclusively on lung-specific biomarker targets via NGS, FISH, PCR
and/or IHC. Rosetta Genomics will continue to pursue New York State
approval for its entire menu of test offerings.
About Rosetta Genomics
Rosetta develops and commercializes a broad range of
microRNA-based and other high-value 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. Through the acquisition
of PersonalizeDx, the Company also offers core FISH, IHC and
PCR-based testing capabilities and partnerships in oncology and
urology that provide additional content and platforms that
complement the Rosetta offerings. Rosetta’s cancer testing services
are commercially available through the Philadelphia, PA- and Lake
Forest, CA-based CAP-accredited, CLIA-certified labs. For more
information visit www.rosettagenomics.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 Rosetta Genomics having a
best-in-class FISH testing program, Rosetta Genomics’ testing
turnaround times, Rosetta Genomics enhancing oncologist’s treatment
options and Rosetta Genomics achieving New York State approval for
any or all of its tests, 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
Annual Report on Form 20-F for the year ended December 31,
2014 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/20150806005394/en/
Rosetta GenomicsKen Berlin, 609-419-9003President &
CEOinvestors@rosettagenomics.comorInvestors:LHAAnne
Marie Fields, 212-838-3777afields@lhai.comorBruce Voss,
310-691-7100bvoss@lhai.com
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