www.fdanews.com/articles/108756-diagnostic-test-based-on-microrna-technology-receives-approval
Diagnostic Test Based on MicroRNA Technology Receives Approval
July 22, 2008
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.