Rosetta Genomics Ltd, Israel and Jersey City, NJ, reports its molecular test based on proprietary microRNA technology, developed and validated by Columbia University Medical Center (CUMC), has been approved for clinical use by the New York State Department of Health Clinical Laboratory Evaluation Program.

CUMC is finalizing the commercial aspects of the test and will announce its clinical availability to patients nationwide after details are finalized later this year.

"This is a landmark event for us, marking the first step in the transformation of Rosetta Genomics into a commercial diagnostics company," said Amir Avniel, the company’s president and CEO. "Our proprietary microRNA platform technologies, which this test is based on, have enabled Columbia University Medical Center’s high complexity molecular pathology laboratory to develop a highly sensitive and specific test, which is a key for optimal administration of targeted therapies for this devastating cancer.”

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%. The test uses microRNAs’ sensitivity and specificity as biomarkers, which may offer a standardized and objective method for lung cancer classification.

"We value our partnership with Columbia University Medical Center and we look forward to continuing this collaboration," noted Ronen Tamir, the company’s chief commercial officer. "At the same time, once we complete the previously announced acquisition of Parkway Clinical Laboratories Inc in Pennsylvania, we plan to complement CUMC’s commercial efforts by submitting the same type of test, developed and validated by Rosetta, for regulatory approval in the fourth quarter of 2008."

The advent of targeted, lung-cancer therapies directed at specific cellular alterations demands the most accurate classification possible for non-small cell lung carcinomas (NSCLC). A recently approved angiogenesis inhibitor (bevacizumab(1)) for NSCLC has been shown to be less effective against squamous-cell lung cancer. The targeted therapy includes a black-box warning about substantially higher rates of severe or fatal hemorrhage among patients with squamous NSCLC histology compared with non-squamous NSCLC, which has led squamous-cell histology to be regarded by many as an exclusion criterion for the drug. Several other targeted drugs for NSCLC currently under development may require this type of sensitive differentiation.

Some 185,000 people annually are diagnosed with non-small cell lung cancer nationwide, and an estimated 60,000 patients annually are potential candidates for targeted therapy with bevacizumab in the United States.

Data presented in peer-reviewed publications has shown that two blinded-expert observers, when asked to give an independent histological classification of NSCLC, agreed only 74.7% of the time.
The company expects two additional tests based on its microRNA technology to be validated and submitted for regulatory approval during the second half of 2008 by labs in the United States. 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.

MicroRNAs 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 a way to treat a wide range of human diseases. MicroRNAs have been shown to have different expression in various pathological conditions, and these differences may provide for a novel diagnostic strategy for many diseases.

The company’s integrative research platform combining bioinformatics and lab processes has led to the discovery of hundreds of biologically validated, novel human microRNAs. Building on its IP position and proprietary platform technologies, Rosetta is working on applying these technologies in the development of a range of microRNA-based diagnostic and therapeutic tools, focusing primarily on cancer and women’s health indications.

The first test based on the company’s technology, differentiating squamous from non squamous non-small cell lung cancer, is approved through CUMC’s high complexity molecular pathology lab, and the company expects two additional microRNA diagnostic tests with its technology will be validated and submitted for regulatory approval by licensed clinical labs in the United States in 2008.