Rosetta Genomics Launches OncoGxOne™
May 28 2015 - 09:06AM
Business Wire
Leverages Admera Health’s industry-leading,
next-generation sequencing technology
Provides oncologists with unique solution of
cutting-edge comprehensive genomic and microRNA profiling to
optimize therapeutic decision-making
Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and
provider of microRNA-based molecular diagnostics, today announces
the commercial launch of OncoGxOne, Admera Health’s next-generation
sequencing (NGS) panel that detects a vast number of genetic
alterations implicated in cancer to provide clear, concise and
actionable clinical recommendations from a single, comprehensive
test. OncoGxOne was recently approved as a Laboratory Developed
Test and is the fifth new product introduced by Rosetta Genomics in
2015.
OncoGxOne 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. OncoGxOne 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. OncoGxOne will compete
with currently available genomic profiling offerings through
next-generation sequencing platforms that can identify potentially
actionable cancer-driving mutations, which can be targeted by
specific therapies.
"We are excited to be launching OncoGxOne as it is valuable to
clinicians and patients struggling with a cancer diagnosis because
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.
“OncoGxOne joins Rosetta’s expanding product portfolio of
molecular diagnostics products and complements our suite of tests
including the Rosetta Cancer Origin Test™ for physicians managing
patients with either cancers of unknown or uncertain origin or
those not responding to current treatments due to the uncertainty
of diagnosis. 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 OncoGxOne with our
recently-expanded sales force and expect that over time it will
become an important contributor to our revenues,” concluded Mr.
Berlin.
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 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 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 Rosetta Genomics
Rosetta develops and commercializes a full range of
microRNA-based molecular diagnostics. Founded in 2000, 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. PersonalizeDx’s core
FISH, IHC and PCR-based testing capabilities and partnerships in
oncology and urology 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.
Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta’s future
expectations, plans and prospects, including without
limitation, statements that the commercial launch for
OncoGxOne will be successful and that over time it will become an
important contributor to Rosetta’s revenues, 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/20150528005848/en/
Company:Rosetta GenomicsKen Berlin, 609-419-9003President
& CEOinvestors@rosettagenomics.comorInvestor:LHAAnne
Marie Fields, 212-838-3777afields@lhai.comorBruce Voss,
310-691-7100bvoss@lhai.com
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