The New York State Department of Health has granted final approval to Rosetta Genomics for its RosettaGX Reveal, which is designed to aid in diagnosing indeterminate thyroid cases. Rosetta previously received conditional approval for the test in early 2016. The assay evaluates thyroid nodules that were classified as cytologically indeterminate after a fine needle aspiration (FNA) biopsy. It involves RNA extraction and microRNA profiling on an existing FNA smear, classifies the nodule as benign, suspicious for malignancy, or positive for medullary carcinoma. This information helps providers to determine whether a patient needs a thyroidectomy.
The test has a turnaround time of 7 days and has a 94% success rate in obtaining results from single smear specimens. It is also the first thyroid test that works on existing FNA smears, so no additional FNA passes are necessary to evaluate the nodule’s status. Rosetta’s analysis of its validation study data shows that the test could help prevent up to 75% of unnecessary thyroid surgeries.