REHOVOT, Israel and NEW YORK, October 30 /PRNewswire-FirstCall/ -- Rosetta Genomics, Ltd. , a global leader in microRNA-based diagnostics and therapeutics, announced today it has successfully completed the prevalidation phase for its first diagnostic test. Using a single microRNA, the test is designed to differentiate squamous from non-squamous lung cancer with high sensitivity and specificity.
Rosetta Genomics diagnostic tests are currently undergoing validation testing at Columbia University Medical Center at its Clinical Laboratory Improvement Amendments (CLIA) certified laboratory. The company expects three diagnostic tests to be launched in 2008 including a test for cancer of unknown primary, lung cancer vs. mesothelioma, and the squamous vs. non-squamous lung cancer test which has recently passed the prevalidation phase.
“The results we have seen so far for our microRNA-based diagnostic tests are very encouraging,” Said Amir Avniel, President and CEO of Rosetta Genomics. “Results of the prevalidation phase showed the test differentiated squamous from non-squamous lung cancer using microRNA biomarkers identified by us, with both high sensitivity and specificity. We expect the test to be available for clinical use in the first half of 08.”
About microRNAs
MicroRNAs (miRNAs) are recently discovered, naturally occurring small RNAs that act as protein regulators and have the potential to form the basis for a new class of diagnostics and therapeutics. Since many diseases are caused by the abnormal activity of proteins, the ability to selectively regulate protein activity through microRNAs could provide the means to treat a wide range of human diseases. In addition, microRNAs have been shown to have different expression levels in certain diseased versus normal tissues. As a result, these differences potentially provide for a novel diagnostic strategy for many diseases. MicroRNAs are thought to play a key role in the differentiation of cells into specific cell types performing various functions in the body.
About Rosetta Genomics
Rosetta Genomics is a leader in the development of microRNA-based diagnostics and therapeutics. 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 IP position and strategic alliances with leading biotechnology companies, Rosetta Genomics is working to develop a full range of diagnostic and therapeutic products based on microRNAs. The company’s primary focus is in the development of microRNA-based products to diagnose and treat different forms of cancer and other diseases
Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta’s future expectations, plans and prospects, including without limitation, statements relating to the role of microRNAs in human physiology and disease, and the potential of microRNAs in the diagnosis and treatment of disease, and the expected timing of validation and launch of our diagnostic tests 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 and develop novel diagnostics products, which is unproven and may never lead to marketable products; Rosetta’s ability to fund and the results of further pre-clinical and clinical trials; Rosetta’s ability to obtain, maintain and protect the intellectual property utilized by Rosetta’s products; Rosetta’s ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Rosetta’s 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 product candidates, all of which are in early stages of development; Rosetta’s ability to obtain regulatory approval for products; 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, 2006 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.
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