FDA Clears Siemens’ New Differential Graves’ Disease Assay

Apr 08, 2016

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%.1


For more information about the IMMULITE 2000/2000 XPi TSI assay, visit usa.siemens.com/TSI.



Contact for journalists

Lance Longwell
Siemens Healthcare
Phone: (610) 448-6341; Email: lance.longwell@siemens.com
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Siemens AG (Berlin and Munich) is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. The company is active in more than 200 countries, focusing on the areas of electrification, automation and digitalization. One of the world’s largest producers of energy-efficient, resource-saving technologies, Siemens is No. 1 in offshore wind turbine construction, a leading supplier of gas and steam turbines for power generation, a major provider of power transmission solutions and a pioneer in infrastructure solutions as well as automation, drive and software solutions for industry. The company is also a leading provider of medical imaging equipment – such as computed tomography and magnetic resonance imaging systems – and a leader in laboratory diagnostics as well as clinical IT. In fiscal 2015, which ended on September 30, 2015, Siemens generated revenue of €75.6 billion and net income of €7.4 billion. At the end of September 2015, the company had around 348,000 employees worldwide. Further information is available on the Internet at www.siemens.com.


1McKee A, Peyerl F. TSI assay utilization: impact on costs of Graves’ hyperthyroidism diagnosis. AJMC. 2012;18(1):1-15.