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FDA-cleared Graves’ disease assay, 5/16

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May 2016—Siemens Healthcare Immulite 2000/2000 XPi TSI assay for the diagnosis of Graves’ disease is FDA cleared. The assay detects the presence of thyroid-stimulating antibodies only, is fully automated, and produces results in 65 minutes. The test’s specificity and speed enable a more accurate diagnosis of Graves’ disease patients, leading to faster treatment and improvement in patients’ quality of life, the company says. Incorporating the thyroid-stimulating immunoglobulins 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).

Siemens Healthcare, 877-229-3711

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