ATHENS, Ohio--(BUSINESS WIRE)--Diagnostic HYBRIDS announces the FDA clearance, for marketing under the 510(k) pre-notification process, of the Thyretain TSI Reporter BioAssay. Thyretain is an in vitro diagnostic use test that specifically detects auto-antibodies called thyroid stimulating immunoglobulins (TSI) in patient serum. Thyretain is the first FDA-cleared test that specifically detects TSI and is to be used as an aid in the differential diagnosis of Graves’ disease, an autoimmune thyroid disorder. The Thyretain TSI Reporter BioAssay Kit is available for commercial use after a recently completed, 2-phase multi-site, clinical trial of the product in nearly 600 patients.
