The Trouble with Lyme Testing

LYMEPOLICYWONK: The CDC, the FDA and Lyme Disease Lab Tests: Two-Tiered Tests, IGeneX, the C6, and the New Culture Test

The CDC website now states that before the CDC will recommend new tests, “their performance must be demonstrated to be equal to or better than the results of the existing procedure, and they must be FDA approved.” But is FDA approval required for diagnostic tests? No, FDA approval is only required for tests that are marketed to other labs. Single lab tests, like those offered by IGeneX and Advanced Laboratory Services (ALS) do not require FDA approval. Instead, federal law requires that they undergo a rigorous validation process established by the Centers for Medicare and Medicaid Services (CMS) and Clinical Laboratory Improvement Amendments (CLIA). CMS and CLIA require developers to prove that their tests are accurate, precise, sensitive, and specific prior to marketing. Both IGeneX and ALS diagnostic tests are CLIA and CMS approved. Why is the CDC asking for more than compliance with federal regulations?

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Source: (formerly CALDA)

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