SOURCE: Rosetta Genomics, Ltd.

November 06, 2013 08:30 ET

Rosetta Genomics Reports First Payment From the UK's National Health Service for the Rosetta Cancer Origin Test™

PRINCETON, NJ and REHOVOT, ISRAEL--(Marketwired - Nov 6, 2013) - Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces that the National Health Service (NHS) of the United Kingdom (UK), the world's largest publicly-funded health service, has made its first payment to the Company for use of the Rosetta Cancer Origin Test™ on a British citizen. The accurate identification of the primary tumor type in primary and metastatic cancer including cancer of unknown or uncertain primary (CUP) is important in guiding clinician treatment decisions to maximize patient outcomes. 

John Bridgewater, M.D., University College London Hospital, UCL Cancer Center, one of the UK's leading experts on CUP and the patient's treating physician, noted, "Cancers of unknown primary are a high priority in the UK health system as evidenced by the requirements to have CUP Clinics at all Cancer Centers. We are very pleased that the NHS has understood the importance of the Cancer Origin Test to better define the best therapeutic choices in these cases, and expect to continue to improve the care of our patients through utilization of this test."

"We are very pleased with this payment from the NHS, for although it does not signify a universal policy decision, it does represent a pathway for individual patients to gain access to this important test and shows that the NHS recognizes the clinical value of our Cancer Origin Test, in conjunction with the treating oncologist's assessment," stated E. Robert Wassman, M.D., Rosetta's Chief Medical Officer. 

There are approximately 12,000 new cases of CUP in the UK each year, representing approximately 5% of all cancer diagnosis. Historically, nearly all cases are fatal within one year and the median survival is between three and seven months for an unselected population1. The current option of a generic regimen of broadly targeted palliative chemotherapy is non-specific with correspondingly low response rates and duration. Multiple chemotherapy regimens have failed to improve this survival, suggesting that a single regimen approach to this collective group of heterogeneous cancers is unlikely to be successful2-4.

"Molecular profiling with Rosetta's Cancer Origin Test has demonstrated clinical validity in identifying cancer origins, which may provide valuable information for defining more specific treatment options. We continue to generate clinical data demonstrating improved outcomes that support the adoption of our microRNA test services in combination with molecularly-targeted therapies to treat CUP," said Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "This recent payment by the NHS is another important step in providing CUP patients in the UK with access to valuable clinical information that can guide treatment decisions and impact outcomes."

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). 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's development or commercialization of molecular diagnostics, the market acceptance of Rosetta's cancer testing services, particularly the Rosetta Cancer Origin Test™, Rosetta's development of personalized medicine products and services, Rosetta achieving and maintaining Medicare coverage for its' tests and Rosetta securing any future payments from international payors, including NHS, 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.

1. Shaw PH, Adams R, Jordan C, Crosby TD. A clinical review of the investigation and management of carcinoma of unknown primary in a single cancer network. Clinical Oncology 2007;19:87-95.
2. Culine S, Lortholary A, Voigt JJ, et al. Cisplatin in combination with either gemcitabine or irinotecan in carcinomas of unknown primary site: results of a randomized phase II study--trial for the French Study Group on Carcinomas of Unknown Primary (GEFCAPI 01). J Clin Oncol 2003;21:3479-82.
3. Gross-Goupil M, Fourcade A, Blot E, et al. Cisplatin alone or combined with gemcitabine in carcinomas of unknown primary: Results of the randomised GEFCAPI 02 trial. European Journal of Cancer 2012;48:721-7.
4. Hainsworth JD, Spigel DR, Farley C, Thompson DS, Shipley DL, Greco FA. Phase II Trial of Bevacizumab and Erlotinib in Carcinomas of Unknown Primary Site: The Minnie Pearl Cancer Research Network. J Clin Oncol 2007;25:1747-52.

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