SOURCE: Rosetta Genomics, Ltd.

September 12, 2013 08:30 ET

Rosetta Genomics Granted U.S. Patent Allowance

Covers Methods of Use and Composition of Matter for Diagnosing Risk and Treatment Planning for Preeclampsia

PRINCETON, NJ and REHOVOT, ISRAEL--(Marketwired - Sep 12, 2013) - Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces that the U.S. Patent and Trademark Office granted the Company a Notice of Allowance in connection with U.S. Patent Application Number 12/864,424, titled "Methods and Compositions for Diagnosing Complications of Pregnancy."

The claims in the patent allowance refer to a method of use and composition of matter for determining the risk of developing preeclampsia and the development of a treatment strategy based on the expression of a microRNA known as microRNA-122a, or miR-122a.

"Preeclampsia is a serious condition that affects 3-5% of all pregnancies and contributes significantly to increased morbidity and mortality in both mothers and babies. Given the challenges of clinical recognition and the magnitude of impact when preeclampsia goes untreated, improved early diagnosis is vital to improve outcomes of pregnancy," noted E. Robert Wassman, MD, FAAP, FACMG, Rosetta Genomics' Chief Medical Officer. "In my experience, the reproductive field has been keenly feeling this unmet need, and to date all attempts to resolve this diagnostic and therapeutic challenge remain inadequate."

"We continue to pursue patent protection for our intellectual property and are pleased to receive this new patent allowance in obstetrics. Preeclampsia is a major cause of maternal, fetal and neonatal morbidity and mortality, and it continues to be one of the great challenges in obstetrics. A screening test in early pregnancy that identifies women at risk of developing preeclampsia would allow obstetricians to commence prophylactic treatments, and instigate high-risk surveillance protocols," stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "We remain committed to executing our intellectual property strategy and to expanding our leadership position in microRNA technology as it protects our current products, provides the foundation for new product development and offers multiple opportunities for potential development partnerships as well as transactions to monetize IP."

Rosetta's robust patent portfolio includes 32 issued patents, including 28 in the U.S. In addition, Rosetta has 44 patent applications pending, of which 25 are in the U.S.

About Rosetta Cancer Testing Services (formerly the miRview® product line)
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). Rosetta Mesothelioma Test™ diagnoses mesothelioma, a cancer connected to asbestos exposure. 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™, 60,000 from the Rosetta Mesothelioma 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. For more information, please visit Parties interested in ordering the test 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. Rosetta's cancer testing services are commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab. Frost & Sullivan recognized Rosetta Genomics with the 2012 North American Next Generation Diagnostics Entrepreneurial Company of the Year Award.

Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta's future expectations, plans and prospects, including without limitation, Rosetta's Cancer of Origin Test, Rosetta pursuing any product or service in the field of preeclampsia either on its own or via partnership, improving the ability of physicians to accurately diagnose CUP, the growth in number of samples being processed and billed at Rosetta's CLIA lab, Rosetta's development or commercialization of molecular diagnostics, the market acceptance of Rosetta's cancer testing services, particularly the Rosetta Cancer Origin Test™, Rosetta's capitalization of its microRNA platform, Rosetta's patent position and Rosetta's development of personalized medicine products and services 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, 2012 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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