Rosetta Genomics and Columbia University Medical Center announced last week that they have submitted the first cancer diagnostic test based on Rosetta Genomics proprietary microRNA technology for approval to the New York State Department of Health clinic.
The test is designed to differentiate squamous (scale-like) from non-squamous non-small cell lung cancer (NSCLC), classifying squamous cell carcinoma of the lung with sensitivity of 96% (correct positive results) and specificity of 90% (correct negative results). Accurate diagnosis is important for guiding treatment for non-squamous NSCLC with the drug Avastin. In keeping with FDA instructions, Avastin carries a warning about potential severe or fatal hemorrhage in patients with squamous NSCLC histology.
Ronen Tamir, Rosetta Genomics' Marketing and Communications VP, noted that U.S. laboratory standards program (CLIA) requires that the instrument meet certain standards of accuracy and reliability. New York, he said, is the only state in which laboratory testing approval is issued by the State Health Department, and recognized by all U.S.states. This means that with New York Health Department approval, the technological benefits will be available to oncologists throughout the U.S., through Columbia University Medical Center's molecular pathology laboratory, which developed the instrument.
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Tamir said that the NY Health Department's process is expected to continue over a period of up to six months.
The product will be marketed through the medical center, which has paid Rosetta royalties for the use of its microRNA technology. Tamir estimates that the cost of the test will be about $6,000. About 60,000 persons become ill with lung cancer every year in the U.S.
Rosetta developed the diagnostic technology based on microRNA, small molecules which are crucial to the regulation of protein activities in the body. Because many diseases are caused by disturbances in the regulation of protein activity, identification of the microRNAs is expected to be instrumental in the diagnosis of many diseases.
Tamir said that the importance of diagnostics in the development of new pharmaceuticals increases as drugs become more specialized. The firm intends to submit two additional diagnostic tools for approval later this year. One test is designed to differentiate mesothelioma, an asbestos-associated cancer that develops in the pleura, from other cancers that spread to the pleura from other sites. Another test is designed to identify the origin of a metastasis in patients presenting with cancer of unknown primary (CUP) origin.
Rosetta was floated on Nasdaq in February 2007 at $7 per share, and is now traded at $4.95 per share, reflecting a market cap of $59 million.
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