The FDA is moving to regulate Lyme testing, specifically to discontinue tests that aren’t approved ELISA or Western Blots.

The FDA is considering barring laboratory developed testing for Lyme disease.  This means that testing such as the urine LDA/PCR test through IgeneX won’t be available anymore because it isn’t compliant with the IDSA two tier testing approach of an ELISA and then a Western blot.

Here is an article from Lyme Policy that has the detail.

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