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Lung Cancer Diagnostic Test Secures Approval in NY

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http://www.fdanews.com/newsletter/artic ... eId=108756


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Diagnostic Test Based on MicroRNA Technology Receives Approval

The New York State Department of Health Clinical Laboratory Evaluation Program has approved a molecular test, based on Rosetta Genomics' microRNA technology, for clinical use.

When used on a sample of a patient's tumor, the test classifies squamous-cell carcinoma of the lung with sensitivity of 96 percent and specificity of 90 percent. It is the first test to use microRNAs as biomarkers and may offer a standardized and objective method for lung cancer classification, Rosetta said.

The test was developed and validated by Columbia University Medical Center.

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(FDAnews Device Daily Bulletin, July 23, 2008)


The information contained in these articles may or may not be in agreement with my own opinions. They are not posted as medical advice of any kind.

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