Thermo Fisher Scientific Receives FDA Clearance for EliA Anti-Thyroglobulin and Anti-Thyroid Peroxidase Tests for Autoimmune Thyroid Disease

PHILADELPHIA--(BUSINESS WIRE)--– AACC 2016 – Thermo Fisher Scientific Inc., the world leader in serving science, today announced that it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) for two new EliA IgG tests for detecting anti-Thyroglobulin (anti-TG) and anti-Thyroid Peroxidase (anti-TPO) autoantibodies in serum or plasma. The CLIA-moderate laboratory tests are performed on the fully-automated Phadia 250/2500/5000 Laboratory Systems.

Thyroid autoimmunity comprises a number of distinct but pathogenically related autoimmune disorders of the thyroid gland, such as Graves’ disease or Hashimoto’s thyroiditis. Among other things, these diseases are characterized by the presence of autoantibodies, such as anti-Thyroid Simulating Hormone (TSH) receptor, anti-thyroglobulin (TG) or anti-thyroid peroxidase (TPO). More than 98 percent of Hashimoto’s thyroiditis patients have autoantibodies directed to TG or TPO or both.

EliA anti-TG and anti-TPO tests quantitatively measure a patient’s autoantibodies to thyroglobulin or thyroid peroxidase, providing information that helps clinicians in the diagnosis of autoimmune thyroid diseases. These new EliA tests, formerly offered as ImmunoCAP tests, provide higher sensitivity with similar or higher specificity. Optimized sensitivity and specificity minimizes false negative or positive results, and maximizes detection of patients with serious disease.

For more information on the EliA Autoimmunity Assays and Phadia Laboratory Systems, call 800.346.4364.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $17 billion and more than 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.