Rosetta Genomics Expands Molecular Diagnostics Test Menu with Launch of Three New Product Offerings
February 25 2016 - 8:00AM
Business Wire
HEME FISH, BRAF Lung and NRAS Colon Assays
Expand Oncology Franchise in Common Hematologic Cancers and Solid
Tumors
Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and
provider of microRNA-based and other molecular diagnostic testing
services, announces the launch of three high-value molecular
diagnostic offerings in order to better serve current and
prospective clients with a broader molecular test menu. HEME FISH,
a portfolio of disease-specific diagnostic, prognostic and
predictive test panels for the various hematologic malignancies,
BRAF mutation analysis for lung cancer and NRAS mutation analysis
for colon cancer are now available through the Company’s Lake
Forest, CA-based laboratory, which it acquired in 2015.
These tests further expand the Company’s robust solid tumor
service offering and provide clients with the ability to order the
Company’s new molecular testing services for their liquid
tumors.
HEME FISH encompasses 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. Rosetta is
expanding its portfolio in Hematology by leveraging years of
experience and recognized competence in FISH test development.
BRAF Lung and NRAS Colon are mutation analysis
assays that are performed by CAST PCR™ technology. These assays are
highly specific and sensitive and can detect as low as 0.5% mutated
DNA in a sample that contains large amounts of normal, wild-type
gDNA. Certain non-small cell lung cancer (NSCLC) patients who
harbor BRAF V600E mutations have been known to respond to targeted
BRAF kinase inhibitors. Colon cancer patients with NRAS mutations
are less likely to respond to Epidermal Growth Factor
Receptor-directed therapies, and NRAS has been included as an
important biomarker in the most recent version of the National
Comprehensive Cancer Network guidelines.
“Lung, colon and hematologic cancers are some of the most
prevalent cancers worldwide. The commercial launch of these three
high-value assays expands our diagnostic testing services in
oncology and provides an even more comprehensive menu of testing
services to the oncologists and pathologists we serve. Importantly,
each of these tests provides clinicians with information that can
enhance the diagnosis and treatment plans for their patients,”
stated Kenneth A. Berlin, President and Chief Executive Officer of
Rosetta Genomics. “These tests will be included as covered tests
with America’s Choice Provider Network and our current contracted
population of 210 million commercial and Medicare covered lives.
Furthermore, these additions to our broad molecular testing
portfolio enhance our competitive position by allowing us to
service more of the needs of our oncology and pathology customers.
”
“We are particularly excited about the revenue opportunity for
our HEME FISH panel of tests as the Centers for Medicare &
Medicaid Services recently announced significant reimbursement
increases for these tests effective January 1, 2016 and we already
have one large customer committed to ordering this panel on a
consistent basis. We expect this new offering to contribute to
Rosetta’s revenue growth in the clinical testing market this year
as well as over the next several years. In addition, our recognized
expertise in FISH and our growing menu of tests serving the
hematology-oncology and pathology markets will help strengthen our
position with leading managed care plans as a provider of choice
for high-quality FISH testing and should enhance our goal to sign
additional participation agreements in 2016,” 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 clinically meaningful
areas. 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. 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 third party payor contracts and
reimbursement rates 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/20160225005403/en/
Rosetta Genomics:Ken Berlin, 267-298-1159President &
CEOinvestors@rosettagenomics.comorRosetta Genomics
Investors:LHAAnne Marie Fields,
212-838-3777afields@lhai.com
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