REHOVOT, Israel and JERSEY CITY, New Jersey, October 2 Rosetta Genomics, Ltd. (NASDQ: ROSG), a leader inthe development of microRNA-based diagnostic and therapeutic products,announced today the initiation of a clinical assessment study with the JohnsHopkins University School of Medicine. The study will compare RosettaGenomics' miRview(TM) squamous, which differentiates squamous from nonsquamous non small cell lung cancer, with available immunohistochemistrymethods.
"We are excited to be collaborating once more with the excellentscientists at Johns Hopkins University," said Dr. Dalia Cohen. "Having thismicroRNA-based test assessed for clinical validity by faculty at one of thecountry's top cancer research centers is viewed by us as a strong indicationto the interest this product and our technology are generating in theoncology world."
Differentiating squamous from non squamous cell lung cancer presents achallenge to physicians, but until recently this differentiation was notparticularly relevant from a therapeutic or prognostic standpoint since nodrug was designed for a specific NSCLC sub-type.
A recently approved angiogenesis inhibitor for NSCLC has been shown tohave severe side effects for squamous-cell lung cancer patients. Furthermore,this targeted therapy includes a black-box warning about substantially higherrates of severe or fatal hemorrhage among NSCLC patients with predominantlysquamous histology. This has led patients with squamous-cell histology to beregarded by many as inappropriate candidates for therapy with this drug. Inaddition, several other targeted drugs for NSCLC currently under developmentmay require this type of accurate differentiation due to different sideeffect profiles or different levels of efficacy.
Combining Rosetta Genomics' proprietary microRNA extraction technologyfrom FFPE samples, sensitive quantification platforms, and microRNA molecularbiomarkers identified by the company, Rosetta Genomics has developed a testwhich differentiates squamous cell carcinoma of the lung from non-squamousNSCLC. This test, which is the subject of the study to be conducted at JohnHopkins, is in the final stages of development and is expected to becommercially available by the fourth quarter of 2008.
In July, Columbia University Medical Center's (CUMC) High ComplexityMolecular Pathology Laboratory received the approval of the New York Stateregulators for a test differentiating Squamous NSCLC from other NSCLC. Thistest, which is based on Rosetta Genomics' technology, exhibited sensitivityof 96 percent and specificity of 90 percent.
MicroRNAs (miRNAs) are recently discovered, naturally occurring, smallRNAs that act as master regulators and have the potential to form the basisfor a new class of diagnostics and therapeutics. Since many diseases arecaused by the abnormal activity of proteins, the ability to selectivelyregulate protein activity through microRNAs could provide the means to treata wide range of human diseases. In addition, microRNAs have been shown tohave different expression in various pathological conditions. As a result,these differences may provide for a novel diagnostic strategy for manydiseases.
About Johns Hopkins University
Founded in 1876, the Johns Hopkins University was the first researchuniversity in the United States. The university's emphasis on both learningand research-and on how each complements the other-revolutionized U.S. highereducation. Today, Johns Hopkins has ventured from its home in Baltimore tocountries throughout the world-China, Italy and Singapore, among many others.It remains a world leader in teaching, patient care and discovery.
About Rosetta Genomics
Rosetta Genomics (Nasdaq: ROSG) is a leader in the field of microRNAs.Founded in 2000, the company's integrative research platform combiningbioinformatics and state-of-the-art laboratory processes has led to thediscovery of hundreds of biologically validated novel human microRNAs.Building on its strong IP position and proprietary platform technologies,Rosetta Genomics is working on the application of these technologies in thedevelopment of a full range of microRNA-based diagnostic and therapeutictools, focusing primarily on cancer and various women's health indications.The first microRNA diagnostic test applying Rosetta Genomics' technology hasbeen approved for clinical use by the State of New York, and the companyexpects it will be launched by licensed clinical laboratories in the UnitedStates in 2008.
Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta's futureexpectations, plans and prospects, including without limitation, statementsrelating to the role of microRNAs in human physiology and disease, thepotential of microRNAs in the diagnosis and treatment of disease, Rosetta'sability to successfully develop a test differentiating Squamous NSCLC fromother NSCLC and the expected timing of commercial launch of tests usingRosetta's microRNA technology, constitute forward-looking statements for thepurposes of the safe harbor provisions under The Private SecuritiesLitigation Reform Act of 1995. Actual results may differ materially fromthose indicated by these forward-looking statements as a result of variousimportant factors, including risks related to: Rosetta's approach to discoverand develop novel diagnostics and therapeutic tools, which is unproven andmay never lead to marketable products or services; Rosetta's ability to fundand the results of further pre-clinical and clinical trials; Rosetta'sability to obtain, maintain and protect the intellectual property utilized byRosetta's products; Rosetta's ability to enforce its patents againstinfringers and to defend its patent portfolio against challenges from thirdparties; Rosetta's ability to obtain additional funding to support itsbusiness activities; Rosetta's dependence on third parties for development,manufacture, marketing, sales, and distribution of products; Rosetta'sability to successfully develop its candidate tools, products and services,all of which are in early stages of development; Rosetta's ability to obtainregulatory clearances or approvals that may be required for its products andservices; the ability to obtain coverage and adequate payment from healthinsurers for the products and services comprising Rosetta's technology;competition from others using technology similar to Rosetta's and othersdeveloping products for similar uses; Rosetta's dependence on collaborators;and Rosetta's short operating history; as well as those risks more fullydiscussed in the "Risk Factors" section of Rosetta's Annual Report on Form20-F for the year ended December 31, 2007 as filed with the Securities andExchange Commission. In addition, any forward-looking statements representRosetta's views only as of the date of this release and should not be reliedupon as representing its views as of any subsequent date. Rosetta does notassume any obligation to update any forward-looking statements unlessrequired by law.Contact: Investors: Joshua Gordon, M.D., T: +1-201-946-0561, E: email@example.com ; Media: Ron Kamienchick, T: +1-646-509-1893, E: firstname.lastname@example.org .
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