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FDA clears TSI assay for Graves’ disease

Siemens Healthcare’s thyroid-stimulating immunoglobulin assay for the diagnosis of Graves’ disease, a common cause of hyperthyroidism, has been cleared by the FDA. The Immulite 2000/2000 XPi TSI assay detects the presence of thyroid-stimulating antibodies only, making the differential diagnosis of Graves’ disease faster and more accurate, according to the company. Incorporating the TSI assay into existing diagnostic algorithms can reduce overall direct costs of Graves’ disease diagnosis by up to 43 percent and the net cost of avoiding misdiagnosis by up to 85 percent (McKee A, et al.Am J Manag Care. 2012;18[1]:e1¬–e14). The assay is fully automated and produces results in 65 minutes.

 

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