The Study Will Correlate the Results of Rosetta Genomics' MicroRNA-Based CUP Assay With Diagnostic Work Conducted at M.D. Anderson Cancer Center Data on the Company's MicroRNA-Based CUP Assay and its High Sensitivity and Accuracy was Recently Published in the April Issue of Nature Biotechnology
REHOVOT, Israel and JERSEY CITY, New Jersey, August 11 /PRNewswire-FirstCall/ -- Rosetta Genomics, Ltd. (NASDQ: ROSG), a leader in the development of microRNA-based diagnostic and therapeutic products, announced today the initiation of a clinical validation study with The University of Texas M. D. Anderson Cancer Center (MDACC). The study will focus on Rosetta Genomics' microRNA-based test that identifies the primary site of cancer of unknown primary (CUP). The study will include one hundred patients who are diagnosed with CUP at MDACC, and who meet the eligibility criteria. Rosetta Genomics expects this test to be submitted for regulatory approval in the second half of 2008.
"The initiation of this validation study is an integral part of the commercialization roadmap for our diagnostic tests, as we advance them towards use in a clinical setting," said Amir Avniel, President and CEO of Rosetta Genomics. "We believe the initiation of this study for our CUP assay with a leading cancer research center such as M. D. Anderson attests to the critical unmet need this test addresses." CUP is a heterogeneous group of cancers that constitutes 3-5% of all cancers with a poor median survival of 6-10 months(1). Each year, approximately 70,000 patients in the United States are diagnosed with CUP. A patient is typically diagnosed with CUP only after undergoing a wide range of tests, including various imaging tests such as x-ray, CT, MRI, and PET, which often fail to identify the origin of the cancer.
Presently, the choice of treatment for metastatic cancer is largely dependent on the nature of the primary tumor. Patients with CUP pose a therapeutic dilemma and treatment is often empiric with a "trial and error" approach. In the era of rapidly growing effective cytotoxic and targeted therapies for known cancers, quicker and more accurate methods of identifying the tissue of origin of CUP cases would permit the use of these therapies, thereby improving the chances of achieving a response and possibly extending the patient's survival.
"The current gold standard diagnostic evaluation for CUP consists of a careful history and physical examination, laboratory tests, imaging studies, invasive studies when necessary, and thorough pathologic evaluation. This process is lengthy and exposes the patient to unnecessary toxicities," noted Dr. Gauri Varadhachary (M.D. Anderson - Please insert title). "Rosetta Genomics' microRNA-based CUP assay may present an alternative test to current diagnostic practices. This study aims to validate their assay as well as compare its performance with current tests for CUP."
MicroRNAs (miRNAs) are recently discovered, naturally occurring, small RNAs that act as master 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 in various pathological conditions. As a result, these differences may provide for a novel diagnostic strategy for many diseases.
About Rosetta Genomics
Rosetta Genomics (Nasdaq: ROSG) is a leader in the field of microRNAs. 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 proprietary platform technologies, Rosetta Genomics is working on the application of these technologies in the development of a full range of microRNA-based diagnostic and therapeutic tools, focusing primarily on cancer and various women's health indications. The first microRNA diagnostic test applying Rosetta Genomics' technology has been approved for clinical use by the State of New York, and the company expects it will be launched by licensed clinical laboratories in the United States in 2008.
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, the potential of microRNAs in the diagnosis and treatment of disease and the Company's ability to successfully develop CUP 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 and therapeutic tools, which is unproven and may never lead to marketable products or services; 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 candidate tools, products and services, all of which are in early stages of development; 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; 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, 2007 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.
(1) Bugat, R., et al., Summary of the Standards, Options and
Recommendations for the management of patients with carcinoma of unknown
primary site (2002). Br J Cancer, 2003. 89 Suppl 1: p. S59-66.
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