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Quidel Gets CE Mark for Autoimmune Thyroiditis Assay

NEW YORK (360Dx) – Quidel said Wednesday that it has received CE marking for its Thyretain TBI Reporter BioAssay used in the qualitative detection in serum of autoantibodies that block thyroid-stimulating hormone receptors.

Quidel’s assay employs a patented technology to detect thyroid-blocking immunoglobulin (TBI) and enables highly complex laboratories to diagnose autoimmune thyroiditis in a few days. Until now, a method to detect it has not been available in the market, the firm said.

"We've developed a test that can truly make a difference in the lives of those who are suffering from [autoimmune thyroiditis], a disease that can take years to diagnose," Douglas Bryant, president and CEO of Quidel, said in a statement.

Autoimmune thyroiditis, or Hashimoto's disease, is a chronic inflammatory disorder of the thyroid gland caused by abnormal blood antibodies and white blood cells attacking and damaging healthy thyroid cells.

Thyroid-blocking immunoglobulin, or TBI, blocks the thyroid-stimulating hormone from binding to its own receptor, and stops the intracellular signaling cascade required for the production and secretion of thyroid hormones.  

Quidel said that the CE-marked assay is available for sale in Europe, but not yet available in the US.