Thyretain TSI Reporter BioAssay test for detecting auto-antibodies attains the FDA clearance

October 07, 2015

???When used earlier when hyperthyroidism is first suspected, this assay may provide primary care physicians and patients alike reliable diagnostic information when classic symptoms of goiter or thyroid-related eye disease (ophthalmopathy) are absent,??? said Jeff Houtz, Senior Product Manager for Thyretain. Houtz further noted that earlier diagnosis of Graves?? disease may lead to an increased awareness and consideration of medical therapy before a decision to radio-ablate the patient??s thyroid is chosen.

Graves?? disease affects 1-2% of the population, and mostly appears in women in their forties. Thyretain will enable physicians to detect TSI in the bloodstream and assist them in confirming the diagnosis of Graves?? disease sooner than with standard thyroid test panels only.

According to Elaine Moore, MT (ASCP), ???this new bio-assay for TSI from Diagnostic Hybrids offers greater specificity as it only detects the TSI present in a patient??s serum, aiding in a more accurate early diagnosis of Graves?? disease, and with further studies may be shown useful for evaluating the patient's response to therapy, and predicting remission from disease.??? Moore is a Graves?? disease patient and author of ???Graves?? Disease, A Practical Guide.???

The Thyretain TSI Reporter BioAssay will be made available through major commercial reference laboratories in the U.S., and in select hospital systems, within forty-five days.