REHOVOT, Israel and NORTH BRUNSWICK, New Jersey, May 21 /PRNewswire-FirstCall/ -- Rosetta Genomics , a leading microRNA company, announced today it has signed a research agreement with Columbia University Medical Center to advance its lead cancer diagnostic. Under the terms of the agreement, Columbia University Medical Center will utilize its Clinical Laboratory Improvement Amendments (CLIA) certified laboratory to perform clinical validation of the Company’s lead diagnostics program for Cancer of Unknown Primary (CUP). This is Rosetta Genomics’ first agreement for clinical validation of one of its cancer diagnostic tests. The company is developing several microRNA-based diagnostics at its R&D facilities in Israel and the United States.
The Company’s CUP diagnostic, currently in the final stages of development, is designed to assist clinicians in identifying the origin of tumors which have metastasized throughout the body. A cancer “metastasizes” when it spreads from its site of origin to other places in the body. It is estimated that in 40,000 to 70,000 new cancer patients each year the site of origin of the tumor is not known at presentation nor is a definitive diagnosis of origin established. Without a definitive diagnosis, the clinician is unable to effectively and efficiently administer optimal therapies for these patients.
“Establishing a relationship with an experienced research team at a state-of-the-art CLIA approved laboratory is essential to the rapid advancement of our CUP diagnostic,” noted Dalia Cohen, PhD, Rosetta Genomics, Global Head of Research and Development. “We believe we have found the perfect mix of scientific expertise and capability at Columbia University Medical Center. Our proprietary diagnostic protocol for CUP has demonstrated encouraging results in terms of the large number of cancers which we may be able to identify from the metastases, as well as the overall high accuracy of the test.”
Under the terms of the agreement, Rosetta Genomics will provide Columbia University Medical Center with its proprietary protocol for diagnosing the primary origin of metastatic cancers, which will then be tested and validated using unknown (“blinded”) samples provided by the medical center.
“We look forward to starting the clinical validation of this microRNA-based diagnostic test for cancer of unknown primary,” said Dr. Mahesh Mansukhani, Associate Director of the Molecular Pathology Laboratory at Columbia University Medical Center, who will be leading the validation process. “Our CLIA certified lab has acquired extensive knowledge in validating, obtaining regulatory approval for, and performing various molecular diagnostic tests, such as this one. MicroRNAs have significant potential as powerful biomarkers in various cancers, and we are excited to be involved in the validation of a diagnostic based on these genes. We believe this endeavor is an important next step in bringing such cutting-edge diagnostics to patients and physicians.”
About microRNAs
MicroRNAs (miRNAs) are a recently discovered, naturally occurring form of RNAi. These small RNAs 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, microRNA expression levels have been shown to be correlated with various disease stats and to hold significant potential as diagnostics and prognostic markers
About Cancer of Unknown Primary (CUP)
Cancer of Unknown Primary (CUP) refers to a cancer where the type of the cancerous cells is not readily identified, or a diagnosis of origin is equivocal. This, in turn, makes it difficult for clinicians to administer the appropriate treatment. Cancer of Unknown Primary constitutes 3% to 5% of new cancer cases, and ranks as the fourth most common cause of cancer.
About Columbia University
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, nurses, dentists, and public health professionals at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. www.cumc.columbia.edu
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 infectious diseases. www.rosettagenomics.com
Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta’s future expectations, plans and prospects, including without limitation, statements relating to our ability to successfully develop a microRNA-based diagnostic test for CUP, the role of miRNAs in human physiology and disease, and the potential of microRNAs in the diagnosis and treatment of disease,, 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; obtaining, maintaining and protecting 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 it business activities; Rosetta’s dependence on third parties for development, manufacture, marketing, sales, and distribution of products; the successful development of Rosetta’s product candidates, all of which are in early stages of development; obtaining 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 most recent Registration Statement on Form F-1 on file with the Securities and Exchange Commission. In addition, any forward-looking statements represent Rosetta’s views only as of today 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.
Contact: Media & Investors Burns McClellan, Inc. Clay Kramer T: +1-212-213-0003 investor.relations@RosettaGenomics.com
Rosetta Genomics Ltd
CONTACT: Media & Investors: Burns McClellan, Inc., Clay Kramer, T:+1-212-213-0003, investor.relations@RosettaGenomics.com
