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," Cohen added.
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," he continued.