The Food and Drug Administration and the Centers for Disease Control and Prevention have released a warning about overly inclusive Lyme tests "whose reliability and clinical usefulness have not been adequately established.” The warning noted that some laboratories performed the test on inappropriate specimens and "have not been validated and published in peer-reviewed scientific literature"
Some tests are exempted from the FDA approval process because they are considered “laboratory developed tests” (LDTs). LDTs are developed, manufactured, and provided by a single laboratory for specific diseases. They cannot be marketed to the public, and must be ordered by a doctor. Although labs must comply with Clinical Laboratory Improvement Amendments, there is no independent evaluation of the accuracy or validity of a test. This regulatory gap frees labs from scientifically establishing that a test correctly diagnoses a disease, leaving patients and doctors to decide for themselves which ones are legitimate.
Patients should be wary of tests and laboratories that may not have established reliability or clinical usefulness.
Justin T. Berger is a Partner at Cotchett, Pitre & McCarthy, LLP, where he handles high-profile cases of corporate fraud, including representing whistleblowers in qui tam actions under the federal and California False Claims Acts ...