NEW YORK (GenomeWeb News) – Rosetta Genomics said today that the New York State Department of Health Clinical Laboratory Evaluation Program has approved the use of the firm’s microRNA-based test for differentiating squamous from non-squamous non-small cell lung cancer.
Rehovot, Israel-based Rosetta said that the test classifies squamous-cell carcinoma of the lung with sensitivity of 96 percent and specificity of 90 percent. It is Rosetta’s first molecular test to be commercialized.
Rosetta President and CEO Amir Avniel said in a statement that the firm’s microRNA platform has enabled its partner, Columbia University Medical Center, “to develop a highly sensitive and specific test, which is a key for optimal administration of targeted therapies” for lung cancer.
Rosetta said that CUMC is currently "finalizing the commercial aspects" of the test and will announce its clinical availability "once details are finalized later this year."
The firm is developing two other microRNA-based tests, one for mesothelioma and one for cancer of unknown primary, which it expects to be validated and submitted for regulatory approval in the second half of this year.