Rosetta Genomics Receives Approval from New York State for First-of-its-kind Thyroid Cancer Diagnostic Assay
February 18 2016 - 9:00AM
Business Wire
Conditional Approval makes RosettaGX Reveal™
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 conditional approval status for RosettaGX
Reveal™, its novel microRNA classifier for the diagnosis of
indeterminate thyroid Fine Needle Aspirate (FNA) smears from the
New York State Department of Health (NYSDOH) under the Company’s
Molecular Oncology permit. RosettaGX Reveal is the only molecular
test in the thyroid market that has been validated in a
multicenter, international, blinded study using convenient,
routinely prepared cytology slides.
The assay is CLIA certified, but New York requires an additional
license from the NYSDOH for CLIA-certified tests to be offered to
patients in the state. With this conditional approval, RosettaGX
Reveal 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 that it may request within 60
business days.
“We are very pleased to have approval to market this important
cancer diagnostic for the benefit of physicians and patients in the
vast New York market," stated Kenneth A. Berlin, President and
Chief Executive Officer of Rosetta Genomics. “It is estimated that
nearly 550,000 FNAs are performed on thyroid nodules each year in
the U.S. and that approximately 740,000 are performed annually in
Europe. Interpretation of FNA samples is not always
straightforward, leading to an indeterminate result in up to 30% of
the samples. Many patients with indeterminate results undergo
surgery as a precaution despite the fact that up to 80% of these
cases are benign. This exposes patients to unnecessary surgical
risk and costs the healthcare system hundreds of millions of
dollars. Through an analysis of our validation study data, we
believe we can help prevent up to 75% of unnecessary thyroid
surgeries.”
“In addition to this expanded geographic access, recent managed
care contracting initiatives have resulted in covered lives for
RosettaGX Reveal exceeding 150 million in the U.S. These increases
in geographic and health insurance access, along with the potential
health economic benefits the RosettaGX Reveal assay can bring by
avoiding unnecessary surgeries, should enhance adoption into a
market valued at more than $350 million annually in the U.S. alone.
This market is one that continues to see accelerating penetration
of molecular classifiers such as RosettaGX Reveal, which we expect
to continue over the next several years,” 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. Through the acquisition
of PersonalizeDx, the Company now offers core FISH, IHC and
PCR-based testing capabilities and partnerships 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, respectively. 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 potential health economic benefits
of Rosetta tests, adoption of the Rosetta Genomics tests or
penetration of those tests into the marketplace, benefits to
physicians and patients, and Rosetta Genomics achieving New York
State final 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160218005856/en/
Rosetta GenomicsKen Berlin, President &
CEO267.298.1159investors@rosettagenomics.comorRosetta Genomics
Investor:LHAAnne Marie Fields(212) 838-3777afields@lhai.com
Rosetta Genomics (CE) (USOTC:ROSGQ)
Historical Stock Chart
From Aug 2024 to Sep 2024
Rosetta Genomics (CE) (USOTC:ROSGQ)
Historical Stock Chart
From Sep 2023 to Sep 2024