The New York State Department of Health Clinical Laboratory Evaluation Program has approved for clinical use the first molecular test for lung cancer based on the proprietary microRNA technology of Rosetta Genomics Ltd. (Nasdaq:ROSG). The test was developed and validated by Columbia University Medical Center, which CUMC is finalizing the commercial aspects of this test, after which it will announce its clinical availability to patients nationwide. Rosetta expects to begin marketing by year-end.
Rosetta's share rose 3.2% at the opening on Nasdaq today.
Rosetta president and CEO Amir Avniel said, "This is a landmark event for us, marking the first step in the transformation of Rosetta Genomics into a commercial diagnostics company. We expect our development engines to enable the launch of additional tests based on our technology that have the potential to improve patient care worldwide."
The test, performed on a sample of a patient's tumor, classifies squamous-cell carcinoma of the lung with sensitivity of 96% and specificity of 90%. This is the first test utilizing microRNAs' unique sensitivity and specificity as biomarkers that may offer a standardized and objective method for lung cancer classification.
Rosetta expects two additional tests based on its microRNA technology to be validated and submitted for regulatory approval during the second half of 2008 by laboratories in the US. One test is designed to differentiate mesothelioma, an asbestos-associated cancer that develops in the pleura, from adenocarcinomas that either arise in the lung or spread to the lung and pleura from other sites. Another test is designed to identify the origin of a metastasis in patients presenting with cancer of unknown primary.
Rosetta, a pioneer in developing microRNA as a diagnostic tool, is facing increasing competition from Asuragen Inc. and Regulus Therapeutics LLC. Earlier this year, Rosetta announced its plan to acquire Pennsylvania-based Parkway Clinical Laboratories, which will enable it to validate and register products.
Rosetta chief commercial officer Ronen Tamir added, "Once we complete the previously announced acquisition of Parkway Clinical Laboratories, we plan to complement Columbia University's commercial efforts by submitting the same type of test, developed and validated by Rosetta, for regulatory approval in the fourth quarter of 2008."
Published by Globes [online], Israel business news - www.globes-online.com - on July 22, 2008
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