Rosetta Genomics to Launch Next-Generation Sequencing Panel from Admera Health

OncoGxOne™ leverages Admera Health’s industry-leading, next-generation sequencing technology

Will provide oncologists with unique solution of cutting-edge comprehensive genomic profiling and microRNA profiling to optimize therapeutic decision-making

PRINCETON, N.J. & REHOVOT, Israel--(BUSINESS WIRE)-- Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, today announces plans to introduce 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 (LDT) and this launch stems from Rosetta Genomics’ collaboration with Admera Health announced on October 30, 2014. OncoGxOne™ will be the fourth 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.

"OncoGxOne™ 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. “The addition of this exciting new product to our armamentarium of molecular diagnostics products 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. Awareness of the tissue origin of the cancer helps determine the significance of many specific mutations in directing the best therapy. We see the benefit of combining comprehensive genomic profiling and microRNA profiling as a unique solution to help clinicians optimize effective therapeutic decision-making, and look forward to our broad-based commercial launch of this valuable NGS-based test during this year’s second quarter,” concluded Mr. Berlin.

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; it is the treating physician’s responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, Rosetta Genomics estimates that 200,000 patients a year may benefit from the Rosetta Cancer Origin Test™, 65,000 from the Rosetta Kidney Cancer Test™ and 226,000 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 PGxOne™ test and the EGFR and KRAS sequencing services for Admera Health, as well as Precipio’s oncology tests, which include bone marrow and peripheral blood testing for hematological malignancies, such as leukemias and lymphomas. For more information, please visit www.rosettagenomics.com. Parties interested in ordering the test 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 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. Rosetta’s cancer testing services are commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab.

Forward-Looking Statement Disclaimer

Various statements in this release concerning Rosetta’s future expectations, plans and prospects, including without limitation, statements relating to the launch of OncoGxOne™ and the expected benefit of combining comprehensive genomic profiling and microRNA profiling, 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.

Company Contacts:
Rosetta Genomics
Ken Berlin, President & CEO
(609) 419-9003
[email protected]
or
Admera Health
Brady Millican, Vice President
(863) 670-0928
[email protected]
or
Investor Contacts:
LHA
Anne Marie Fields
(212) 838-3777
[email protected]
or
Bruce Voss
(310) 691-7100
[email protected]

Source: Rosetta Genomics Ltd.

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