M. D. Anderson to Initiate Clinical Validation Study on Rosetta Genomics' MicroRNA-based Diagnostic Assay

Rosetta Genomics, Ltd. has announced 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."

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.