FDA Clears Siemens’ New Differential Graves’ Disease Assay

The IMMULITE 2000/2000 XPi TSI assay is the first automated and semiquantitative TSI assay available for Graves’ disease.

Siemens Healthcare’s new TSI assay makes diagnosis of Graves’ disease (GD) faster and more accurate due to its specificity for GD and rapid turnaround time. Graves’ disease is a common cause of hyperthyroidism worldwide. Though many factors can trigger hyperthyroidism, GD is the result of thyroid-stimulating immunoglobulins (TSI) triggering the uncontrolled production of thyroid hormones in the body. Unlike other currently available diagnostic tests, the IMMULITE 2000/2000 XPi TSI assay detects the presence of thyroid-stimulating antibodies only, making the differential diagnosis of GD faster and more accurate.

While some TSI assays are manual and may take hours to complete, the IMMULITE 2000/2000 XPi TSI assay is fully automated and produces results in only 65 minutes. The assay’s specificity and speed enable a more accurate diagnosis of GD patients, leading to faster treatment and improvement in patients’ quality of life. Incorporating the TSI assay into existing diagnostic algorithms can reduce overall direct costs of GD diagnosis by up to 43% and the net cost of avoiding misdiagnosis by up to 85%.