Rosetta Genomics Expands High-Value Molecular Diagnostic Offering with Launch of OncoGxSelect™
July 28 2015 - 8:00AM
Business Wire
Provides oncologists with comprehensive genomic
profiling solution to optimize therapeutic decision-making in
prevalent lung cancers
Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and
provider of microRNA-based molecular diagnostics, today announced
that OncoGxSelect™, Admera Health’s latest next-generation
sequencing (NGS) oncology panel, has been approved for clinical use
by The New Jersey Department of Health (NJDH). OncoGxSelect™ will
be the sixth new product introduced by Rosetta Genomics in 2015.
The Company expects to launch its seventh new product, a
microRNA-based assay for accurate thyroid nodule classification, by
the end of this quarter.
OncoGxSelect™ leverages Admera Health’s industry-leading NGS
technology. It interrogates 5 genes associated with
highly-prevalent lung cancer types including KRAS, BRAF, EGFR, ROS1
and ALK. It detects point mutations, small insertion/deletions
(indels) and gene fusions to provide clinically actionable results.
OncoGxSelect™ is performed on a modest-sized pathology sample in
the standard format of FFPE (formalin fixed paraffin embedded)
tissue, the same as Rosetta’s other clinical microRNA-based
diagnostics. In lung cancer, the addition of OncoGxSelect adds to
an already broad, comprehensive lung-specific menu to assist in
answering the most difficult clinical questions that face
clinicians treating lung cancer patients.
While OncoGxSelect focuses on lung cancers, OncoGxOne™, another
of Admera Health’s NGS tests launched by Rosetta Genomics last
month, interrogates all types of genomic aberrations in 64 genes,
specifically 56 related to cancer targeted therapy and 8 related to
chemotherapy. This test covers all exons and 5’ and 3’ UTRs for
each gene, as well as all introns that harbor potential gene
translocation breakpoints.
With Rosetta Genomics’ comprehensive diagnostic testing
services, treating physicians now have an array of clinically
relevant options to choose from, whether they want to confirm
primary diagnosis, clarify tumor subtype, perform a full
oncogenomic profile or focus exclusively on lung-specific biomarker
targets via NGS, FISH, PCR and/or IHC.
"We are excited to launch OncoGxSelect™ as part of our
productive partnership with Admera Health. OncoGxSelect™ is
valuable to clinicians and patients struggling with a cancer
diagnosis as it directs the physician to the appropriate targeted
treatment, truly delivering personalized medicine,” said Kenneth A.
Berlin, President and Chief Executive Officer of Rosetta Genomics.
“Feedback from physicians has highlighted the importance of
offering a panel that is limited to those mutations that are truly
actionable. This is particularly helpful as it reduces the ‘noise
and distraction’ of variations of unknown significance.”
Mr. Berlin continued, “OncoGxSelect™ joins Rosetta’s expanding
product portfolio of molecular diagnostics and complements our
broad suite of tests for solid tumors. Combining comprehensive
genomic profiling and microRNA profiling offers a unique solution
to help clinicians optimize effective therapeutic decision-making.
We look forward to a successful commercial launch for OncoGxSelect™
and expect that over time it will become an important contributor
to our revenues.”
About Rosetta Cancer Testing Services
Rosetta Cancer Tests are a series of microRNA-based diagnostic
testing services offered by Rosetta Genomics. The Rosetta Cancer
Origin Test™ can accurately identify the primary tumor type in
primary and metastatic cancer including cancer of unknown or
uncertain primary (CUP). The Rosetta Lung Cancer Test™ accurately
identifies the four main subtypes of lung cancer using small
amounts of tumor cells. The Rosetta Kidney Cancer Test™ accurately
classifies the four most common kidney tumors: clear cell renal
cell carcinoma (RCC), papillary RCC, chromophobe RCC and
oncocytoma. Rosetta’s assays are designed to provide objective
diagnostic data. In the U.S. alone, Rosetta Genomics estimates that
200,000 patients a year may benefit from the Rosetta Cancer Origin
Test™, 62,000 patients from the Rosetta Kidney Cancer Test™ and
222,000 patients from the Rosetta Lung Cancer Test™. The Company’s
assays are offered directly by Rosetta Genomics in the U.S., and
through distributors around the world. In addition to its
proprietary products, the Company markets the Rosetta Genomics
OncoGxOne, PGxOne™ and EGFR and KRAS tests for Admera Health. With
the recent acquisition of PersonalizeDx, the Company now offers a
broader menu of molecular and other assays for bladder, lung,
prostate and breast cancer patients. For more information, please
visit www.rosettagenomics.com. Parties interested in ordering any
of these tests can contact Rosetta Genomics at (215) 382-9000 ext.
309.
About Admera Health
Admera Health is a molecular diagnostics company focused on
personalized medicine. Utilizing advanced genomic technologies and
bioinformatics analysis, Admera Health delivers cost-effective
clinical diagnostics spanning the continuum of care from its
established, CLIA-certified, CAP-accredited laboratory. Admera
Health is a GENEWIZ company. For more information, please visit
www.admerahealth.com.
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 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 and PersonalizeDx’s cancer testing
services are commercially available through the Philadelphia, PA-
and Lake Forest, CA-based CAP-accredited, CLIA-certified labs,
respectively. 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 without
limitation, statements relating to the success of the
commercial launch of OncoGxSelect™, the potential impact of that
product on Rosetta’s revenues, and the ability of that product to
help clinicians optimize effective therapeutic decision-making,
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/20150728005293/en/
Rosetta GenomicsKen Berlin, 609-419-9003President &
CEOinvestors@rosettagenomics.comorAdmera
HealthBrady Millican, 863-670-0928Vice
Presidentbrady.millican@admerahealth.comorInvestors:LHAAnne
Marie Fields, 212-838-3777afields@lhai.comorBruce Voss,
310-691-7100bvoss@lhai.com
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