FDA Clears New Indications for Lyme Disease Diagnostics

The FDA has OK’d four diagnostic tests with new indications for diagnosing 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 Western Blot test, the agency said.

The new assays are easier to interpret in the laboratory due to the streamlined methods for running the tests, CDRH said.