FDA clears new indications for existing Lyme disease tests

FDA clears new indications for existing Lyme disease tests

Silver Spring, MD (STL.News) – Today, the U.S. Food and Drug Administration cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease.  The tests cleared today are the first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run concurrently or sequentially, rather than the current two-step process in which a separate protein test called a Western Blot must be run after the initial EIA test.

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