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FDA Clears Lyme Disease Tests Using New Testing Paradigm

By David Roza
August 1, 2019 at 11:30 AM
FDA on Tuesday (July 30) cleared four tests to help diagnose Lyme disease using a new testing paradigm that FDA says will make the results easier for clinicians to interpret and lead to faster diagnoses so that patients can be treated sooner. The clearance marks the first time a test has been indicated to follow the new testing paradigm, which involves two tests called enzyme immunoassays (EIA) run concurrently or sequentially. “These tests may improve confidence in diagnosing a patient...


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