Laboratory-developed tests (LDTs) are designed, manufactured, and performed by a single CLIA-certified lab. While the FDA has the authority to regulate LDTs, it has
"consistently and accurately identifies, measures or predicts: 1) a disease or condition in an individual; or 2) characteristics related to the clinical status of the individual."
Thus, LDTs have become the
In 2014, the
- Incorrect diagnoses of autism – Exposed children to ineffective treatments, and potentially harmful treatments
- Incorrect diagnoses of Lyme disease – Exposed patients to unnecessary antibiotics
- Incorrect information about heavy metal toxicity in the body – Patients were exposed to unnecessary, and potentially harmful therapies
Oversight would include pre-market review for higher-risk LDTs, such as those used to guide treatment decisions. The vast majority of LDTs are not based on pseudoscience and there were concerns from legitimate medical groups who thought the added expense of regulation would adversely affect them. For example, a non-profit lab running rarely-used tests for university hospitals and the government was opposed to new regulations. Tellingly, though,
The FDA's recent decision to stop work on LDT regulation, according to the
"FDA's announcement is unsurprising in the wake of the unexpected election results. While this announcement is framing the current status of the draft guidances as delayed, given the current political landscape, these draft guidances are dead for all intents and purposes. Republican members of Congress have been among some of the harshest critics of FDA's proposal to expand regulatory oversight of LDTs. FDA did say it would 'continue to work with stakeholders, our new administration, and Congress to get our approach right.' FDA also said, 'We plan to outline our view of an appropriate risk-based approach in the near future.' Nevertheless, with a Republican President committed to less regulation and Republican majorities in both the House and Senate, we believe FDA's efforts to issue far-reaching LDT guidance is moribund for many years."
Fortunately, the bloggers think there are other avenues the FDA can pursue to reign in LDT proliferation.
When the FDA originally announced its intent to more effectively regulate LDTs, it said
"LDT's are important to the continued development of personalized medicine, but it is important that in vitro diagnostics are accurate so that patients and health care providers do not seek unnecessary treatments, delay needed treatments, or become exposed to inappropriate therapies."