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First Cancer Diagnostic Test Based on Rosetta Genomics' Proprietary MicroRNA Technology Receives Regulatory Approval
Date:7/22/2008

s' unique sensitivity and specificity as biomarkers that 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, Chief Commercial Officer at Rosetta Genomics. "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 4th quarter of 2008."

The advent of targeted lung cancer therapies directed at specific cellular alterations now 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. Furthermore, this 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. This has led squamous-cell histology to be regarded by many as an exclusion criterion for this drug. In addition, several other targeted drugs for NSCLC currently under development may require this type of sensitive differentiation.

Approximately 185,000 people are diagnosed with Non Small Cell Lung Cancer each year in the United States, with an estimated 60,000 patients per year 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 percent of the time. Furthermore, sensitivity for squamous cell carcinoma was only 70.9 percent(2). A second study(3) looking at classification of squamous cell carcinoma sh
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SOURCE Rosetta Genomics Ltd
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