A new chapter in the Lyme disease controversy opened in September 2011 when Advanced Laboratory Services, Inc, announced the commercial availability of a new culture test for Borrelia burgdorferi. Some Lyme patient advocacy groups and physicians began encouraging patients to have the $595 test, but others are concerned about the early commercialization of the still-unvalidated test. This concern may result in changes to how the US Food and Drug Administration (FDA) regulates so-called "homebrew" or laboratory-developed tests (LDTs).
Physicians on all sides of the Lyme disease arena agree that a reliable culture test for active Borrelia infection would be a breakthrough. They differ on whether it is a good idea to market a blood test to consumers before it has been validated, peer-reviewed, published, reviewed by the FDA, or widely vetted by infectious disease experts with experience in Borrelia infections.
Joseph J. Burrascano Jr, MD, senior vice president of medical affairs and medical director for Advanced Research Corporation, voiced the complaint of many in the field that the 2-tier Lyme disease test approved and used by Centers for Disease Control and Prevention (CDC) relies on a serologic assay that can only indicate possible past exposure.
"What is very much needed.....
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