Rosetta Genomics Ltd. Launches OncoGxOne

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

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

“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 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.