New York State Grants Final Approval for miRview® lung; Expands Access for Rosetta Genomics' microRNA Diagnostic for Identification of Four Major Subtypes of Lung Cancer New, Targeted Therapies Make Accurate Classification of Lung Cancer Increasingly Important
PHILADELPHIA and REHOVOT, Israel, Nov. 6, 2012 /PRNewswire/ -- Rosetta Genomics (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic assays, announces that the New York State Department of Health has given the Company final approval for its miRview® lung assay following conditional approval issued in June 2012. With this final approval, Rosetta Genomics can continue to offer the miRview® lung assay in all 50 U.S. states. New York is the only U.S. state that requires an independent regulatory review process for laboratory-developed tests.
miRview® lung is the Company's proprietary microRNA-based assay that can accurately differentiate between the four main subtypes of lung cancer using small amounts of tumor cells.
"We are pleased to have final New York State approval for our micro-RNA-based miRview lung assay. This represents an important validation of our technology as many jurisdictions around the world recognize the rigor of review in the state of New York. With the introduction of targeted lung cancer therapies, along with new targeted drugs entering the clinical arena, accurate classification of lung cancer is becoming increasingly important to better assess efficacy profiles and to enhance treatment strategies," noted Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "We look forward to continuing to offer this important assay to the benefit of patients and physicians throughout the U.S. where, according to the National Cancer Institute, there are an estimated 226,000 new cases of lung cancer and an estimated 160,000 lung cancer related deaths expected in 2012."
About miRview® lung
miRview lung accurately identifies the four main subtypes of lung cancer with a sensitivity of 95%, using very small pre-operative biopsies such as fine needle aspirate and cytological samples. The assay differentiates neuroendocrine tumors from non-small cell lung tumors (NSCLC), and then further subtypes neuroendocrine tumors into small cell lung cancer and carcinoid; and subtypes NSCLC tumors into squamous and non-squamous.
About miRview® Products
miRview® products are a series of microRNA-based molecular diagnostic products offered by Rosetta Genomics. The miRview® mets² assay accurately identifies the primary tumor type in patients with primary or metastatic Cancer of Unknown or Uncertain primary (CUP). miRview® meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview® lung accurately identifies the four main subtypes of lung cancer. miRview® kidney accurately classifies the four most common kidney tumors: clear cell renal cell carcinoma (RCC), papillary RCC, chromophobe RCC and oncocytoma. miRview® 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 miRview® mets² test, 60,000 from miRview® meso, 54,000 from miRview® kidney and 226,000 patients from miRview® lung. 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 www.mirviewdx.com. 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 miRview® product line is 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, statements relating to the market acceptance of Rosetta's miRview® assays, particularly miRview® lung, as well as the increasing importance of accurate classification and subtyping of lung cancer and Rosetta's capitalization of its microRNA platform 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, 2011 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.
SOURCE Rosetta Genomics