Rosetta Genomics announces additional performance data from the recently-completed, blinded validation study of RosettaGX Reveal, its microRNA-based diagnostic assay for the classification of indeterminate thyroid nodules.
The "gold standard" for diagnosis is agreement among the three pathologists involved in the study. When compared to this "gold standard," new data demonstrate particularly strong performance in Bethesda classes III and IV of the Bethesda System for Reporting Thyroid Cytopathology (TBSRTC), where the risk of malignancy is low, yet many of these patients are still sent to surgery.
The Company expects these data to be published in a peer-reviewed journal in the coming months.
The high sensitivity, specificity and Negative Predictive Value, as presented at the recent International Thyroid Congress (ITC), along with the strong performance data in Bethesda classes III and IV, are important because patients with indeterminate nodules often have their thyroid surgically removed despite the fact that most of these nodules prove to be benign.
Based on the results from a multi-center, blinded validation study, RosettaGX Reveal could prevent more than 70% of these unnecessary surgeries.
The strong performance demonstrated by the RosettaGX Reveal validation study provides physicians with a high level of confidence when considering whether to forego surgery in cases where a patient has an indeterminate thyroid nodule.
RosettaGX Reveal was launched at the ITC. It is a simple and reliable diagnostic assay that offers a valuable tool for the classification of pre-operative thyroid samples, including those that are presently indeterminate according to cytological evaluation, and is the only assay that can utilize cytology smears.
This assay is the first commercial test that interrogates the same thyroid cells that the cytopathologist viewed for the initial indeterminate diagnosis, which provides a significant level of convenience versus other tests as it eliminates the risks, morbidity and unnecessary pain associated with a second fine needle passage into the patient’s neck.
"As we continue to analyze and parse the data from our multi-center, blinded validation study for RosettaGX Reveal, our confidence grows in its exceptional performance and in our belief that it will be a very competitive assay," said Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.