RosettaGX Reveal
The first thyroid test that works on stained FNA smears, No Additional FNA Pass Required.
99% NPV, 98% Sensitivity (for agreement set) RosettaGX Reveal performance was determined in a multi-center, blinded validation study. 99% NPV and 98% sensitivity (n=150), Bethesda Class III, IV, V) was determined, with 3/3 Pathologists agreeing on diagnosis. 94% success rate in obtaining results from single smear specimens. Additionally, Reveal can be performed on a variety of stain typesSlides are imaged and archived for future retrieval
The accurate diagnosis of thyroid nodules can be challenging, with 15-30% of Fine Needle Aspiration (FNA) samples classified as indeterminate.1 Patients with indeterminate nodules are often referred to surgery, though most of these nodules prove to be benign.
With the advancement of molecular testing with RosettaGX Reveal, physicians are armed with more information than ever about whether surgery is necessary for their patients. This microRNA-based diagnostic assay evaluates cytologically indeterminate thyroid nodules and can help prevent over 75% of unnecessary surgeries for patients with initial indeterminate results.