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Rosetta Receives Conditional Approval for Thyroid Test in NY State

NEW YORK (GenomeWeb) – Rosetta Genomics announced today that it has received conditional approval from the New York State Department of Health (NYSDOH) for the RosettaGX Reveal thyroid cancer diagnostic assay.

The test is designed to analyze the expression of microRNA biomarkers in indeterminate thyroid fine needle aspirate smears to differentiate benign thyroid nodules from malignant ones.

Although the test is CLIA certified, Rosetta said that it requires an additional license from the NYSDOH to offer the test in the state. With the conditional approval, Rosetta may sell the test in New York pending final approval from the health department. 

In August, Rosetta received NYSDOH clearance for its fluorescence in situ hybridization-based ROS1 lung cancer biomarker assay.