ATHENS, Ohio — The U.S. Food and Drug Administration has cleared for market a new thyroid test by Diagnostic HYBRIDS, the diagnostic test developer that has an office and laboratory in Cleveland, Ohio.
The test, called Thyretain TSI Reporter BioAssay, detects antibodies in patient serum that indicate Graves’ disease, an autoimmune disease that affects mostly women in their 40s. Graves’ disease results in an overactive thyroid gland and can be difficult to diagnose because its symptoms mimic those of many other disorders.
“Thyretain is a rapid and reliable bioassay that provides a definitive assessment that could lead to earlier diagnosis of Graves’ disease and better patient management,” said Dr. Frank Schwartz,  professor of endocrinology, J.O. Watson Chair for Diabetes Research, and director of the ARHI Diabetes Center at the Ohio University College of Osteopathic Medicine, in the Diagnostic HYBRIDS release.
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Graves’ disease often is treated by destroying all or part of the thyroid gland through a process called “radio-ablation,” Diagnostic HYBRIDS said. The diagnosis usually comes after several tests, and the radio-ablation treatment is irreversible. 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, the company said.
Thyretain is one of several diagnostic tests that Diagnostic HYBRIDS expects to launch this year. The Athens-based company develops and markets diagnostic and analytical products for a range of viral respiratory diseases, herpes virus infections, and other other viral and thyroid diseases.
