PORTAGE, Mich.--(BUSINESS WIRE)--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 TSH receptor, thyroglobulin (TG) or thyroid peroxidase (TPO). More than 98 percent of thyroiditis patients have autoantibodies directed to either 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 develop comprehensive disease management plans for their patients with autoimmune thyroid disease. These new EliA tests, formerly offered on the ImmunoCAP technology platform, are now designed to provide higher sensitivity and wider measuring ranges to laboratories and clinicians, both of which are important in gaining serologic insights for autoimmune thyroid disease management.
For more information on the EliA Autoimmunity Assays and Phadia Laboratory Systems, please visit the Thermo Scientific product page for Thyroid Diseases.
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.