Rosetta Genomics Ltd. Announces New York State Approval for miRview(R) Lung
Published: Jun 26, 2012
PHILADELPHIA, PA and REHOVOT, ISRAEL--(Marketwire - June 26, 2012) - 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 visit www.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 visit www.rosettagenomics.com.
Various statements in this release concerning Rosetta's future expectations, plans and prospects, including without limitation, the Company potentially receiving final approval by the NYSDOH, 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 risks related to: Rosetta's approach to discover microRNA technology and to work on the application of this technology in the development of novel diagnostics and therapeutic tools, which may never lead to commercially accepted products or services; Rosetta's ability to obtain, maintain and protect its intellectual property; Rosetta's ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Rosetta's need and ability to obtain additional funding to support its business activities; Rosetta's dependence on third parties for development, manufacture, marketing, sales, and distribution of products; Rosetta's ability to successfully develop its products and services; Rosetta's ability to obtain regulatory clearances or approvals that may be required for its products and services; the ability to obtain coverage and adequate payment from health insurers for the products and services comprising Rosetta's technology; the ability to obtain a formal agreement for Medicare coverage and to maintain an equitable reimbursement valuation; competition from others using technology similar to Rosetta's and others developing products for similar uses; Rosetta's dependence on collaborators; and Rosetta's short operating history; as well as 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 Securities and Exchange Commission. 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.
Rosetta Genomics Ltd.
President & CEO
(215) 382-9000 ext. 326
Anne Marie Fields