Atlanta, GA 6/26/12 (StreetBeat) -- Rosetta Genomics (Nasdaq:ROSG), a leading developer and provider of microRNA-based molecular diagnostic assays, announced that the New York State Department of Health ("NYSDOH") has given the Company conditional approval for its miRview® lung assay for testing on patient samples from the State. New York is the only U.S. state that requires an independent regulatory review process for laboratory-developed tests. With this approval, Rosetta Genomics can offer miRview® lung in all 50 U.S. states. In making the assay available pending final approval, the NYSDOH requires the Company to provide any additional information they request within 60 business days. miRview® lung is the Company's proprietary microRNA-based assay that accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells.
"Lung cancer is the second most common cancer and is the primary cause of cancer-related death in both men and women in the U.S. With the introduction of targeted lung cancer therapies, such as Avastin® and Alimta®, and with other targeted drugs entering the clinical arena, accurate classification and subtyping of lung cancer is becoming increasingly important to better assess differential side effects and efficacy profiles and to enhance treatment strategies," said Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "With a sensitivity of 95% for very small sample sizes, such as cytological samples, we believe this assay can be a useful tool for pathologists and we are very pleased to have approval to market this important cancer diagnostic for the benefit of physicians and patients in New York."
About miRview® Products
miRview® are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview® mets and miRview® mets² accurately identify the primary tumor type in primary and metastatic cancer including Cancer of Unknown Primary (CUP). miRview® squamous accurately identifies the squamous subtype of non-small cell lung cancer, which carries an increased risk of severe or fatal internal bleeding and poor response to treatment for certain therapies. miRview® meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview® lung accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. miRview® kidney accurately classifies the four most common kidney tumors: Clear Cell Renal Cell Carcinoma (RCC), Papillary RCC, Chromophobe RCC and Oncocytoma. miRview® tests 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® mets and miRview® mets² test, 60,000 from miRview® squamous, 60,000 from miRview® meso, 54,000 from miRview® kidney and more than 1 million patients worldwide from miRview® lung. The Company's tests are offered directly by Rosetta Genomics in the U.S., and through distributors around the world. For more information, please visitwww.mirviewdx.com. Parties interested in ordering the test can contact Rosetta Genomics at (215) 382-9000 ext. 309.
About Rosetta Genomics
Rosetta Genomics develops and commercializes a full range of microRNA-based molecular diagnostics. Founded in 2000, the Company'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 Genomics is working on the application of these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools. The Company's miRview® product line is commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab. To learn more, please visitwww.rosettagenomics.com.
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