I am extremely upset to see this, as are many Lyme patients. Lorraine Johnson does a great job explaining why this is bad for Lyme patients as well as innovation in the laboratory field. We need less government involvement in medical tests, not more. We have seen what the CDC and FDA have both done to mess Lyme up, and they are still brave enough to keep going.
Please see this article http://lymedisease.org/news/lymepolicywonk/fda-and-lyme-tests-is-it-simply-vested-interests-protecting-vested-interests.html by Ms. Johnson as she says it better than I could.