Rosetta Genomics Ltd. Launches BRAF Mutation Assay

Provides additional information to ensure that oncologists can optimize treatment decisions for their cancer patients

PRINCETON, N.J. & REHOVOT, Israel--(BUSINESS WIRE)--Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and provider of microRNA-based and other molecular diagnostics, announces the launch of a molecular test for BRAF mutation analysis to help personalize therapy for melanoma and colon cancer patients. This newest assay will complement its broad offerings so that oncologists can optimize treatment decisions for their cancer patients.

“The BRAF assay adds to the growing number of testing services we provide, which further strengthens Rosetta Genomics as a leader in delivering personalized diagnostic testing.”

Rosetta Genomics’ BRAF mutation analysis test utilizes highly specific and sensitive Competitive Allele-Specific TaqMan® (CAST) PCR™ technology that can detect as little as 0.5% mutated DNA in a large, normal DNA sample. BRAF mutations occur in up to 50% of malignant melanomas, and several FDA-approved BRAF inhibitor therapies have been introduced to the market for use in patients with late-stage metastatic melanoma.

“We are proud to be launching our sensitive BRAF mutation analysis test as it enhances our portfolio of solid tumor profiling tests, which leverage a broad array of genomics platforms to enable personalized treatment of patients with cancer,” stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. “The BRAF assay adds to the growing number of testing services we provide, which further strengthens Rosetta Genomics as a leader in delivering personalized diagnostic testing.”

About Rosetta Cancer Testing Service

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 150,000 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, OncoGxLung, PGxOne^™ and EGFR and KRAS tests for Admera Health. With the 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 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 but not limited to statements relating to Rosetta’s BRAF assay increasing oncologists’ ability to optimize treatment decisions for their cancer patients, and the sensitivity of Rosetta’s BRAF assay, 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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