So the Quacks are going to win one here. LDT’s are the refuge for pseudo-science.
The FDA has announced that is postponing possible plans to regulate laboratory-developed tests (LDTs) until it it determines what might be acceptable to the incoming administration and Congress. [Firth S. FDA delays guidance on lab-developed tests. MedPage Today, Nov 21, 2016] (LDTs are tests designed, manufactured, and performed by a single CLIA-certified lab.) Although the FDA has the authority to regulate them, it has provided very little oversight of such tests. At present, LDTs do not have to be proven clinically valid. Many are valuable and evidence-based, but, as noted by attorney Jann Bellamy:
LDTs have become the perfect vehicle for pseudoscientific practitioners, like naturopathic “doctors,” chiropractors, and “Lyme literate” and “integrative” physicians, who can test their patients for non-existent conditions and then proceed to “treat” them, sometimes with hundreds of dollars-worth of medically unnecessary dietary supplements. Where the practitioner lacks the legal authority to order lab tests (for example, in states where naturopaths are not licensed), he can simply tell the patient which direct-to-consumer test to order from a lab. Because bogus tests are not covered by insurance, the patient pays out of pocket, sometimes with a markup added by the practitioner. [Bellamy J. Dubious lab tests get reprieve after FDA backs off regulatory plan. Society for Science-Based Medicine Blog, Nov 27, 2016]