Rosetta Genomics Ltd. Expands High-Value Molecular Diagnostic Offering With Launch Of Oncogxselect

Provides oncologists with comprehensive genomic profiling solution to optimize therapeutic decision-making in prevalent lung cancers

PRINCETON, N.J. & REHOVOT, Israel--(BUSINESS WIRE)--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.

“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”

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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