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News From the Food and Drug Administration
September 17, 2019

New Indications for Lyme Disease Tests

JAMA. 2019;322(11):1036. doi:10.1001/jama.2019.13901

Four existing laboratory tests used to confirm a clinical diagnosis of Lyme disease recently received FDA market clearance for new testing indications that may help streamline the diagnostic process.

Lyme disease is caused by the bacterium Borrelia burgdorferi, which is transmitted by infected Ixodes scapularis ticks. The Centers for Disease Control and Prevention received 42 743 reports of confirmed and probable Lyme disease cases in 2017, up more than 17% from 2016. With rising temperatures, the incidence is predicted to increase by about 21% in the United States by mid-century.

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