Tag: direct to consumer testing
Too many lab tests still escape FDA review, threatening patient safety
Even as the lab testing market grows, too many tests escape FDA review based on a meaningless categorization that has nothing to do with patient safety. Congress should pass the VALID Act of 2021, allowing the FDA to adequately regulate direct-to-consumer and other lab tests with the potential to harm the public.
Trump administration announces some COVID-19 tests can skip FDA review, providing new opportunities for dubious lab tests
The Trump administration unexpectedly announced that the FDA will no longer regulate some lab tests, including those for COVID-19. In addition to potentially allowing unreliable COVID tests on the market, the decision creates an opening for more bogus CAM tests.
Everlywell: At-Home Lab Tests That Don’t Make Sense
EverlyWell offers 34 at-home tests for everything from IgG tests for food sensitivities to a Sleep and Stress test. Most of them make no sense and are likely to mislead customers.
Experts slam CAM lab tests, call for better regulation
Experts review the evidence and find that common CAM lab tests have "little or no clinical benefit" and are "a potential risk to patient safety." Regulatory reform is urgently needed to protect the public.
Can DNA testing predict your response to drugs?
Can your genes really predict how you will metabolize certain medications? The FDA has approved the first direct-to-consumer test that claims to do this. How meaningful are the findings?
Direct-to-Consumer Genetic Testing: Road Map or Tarot Cards?
A topic of growing interest (and concern) at SBM is laboratory and diagnostic test pseudoscience. Bogus tests are everywhere, and Kimball Atwood recently discussed several of them. But over the past several years, diagnostic tests have emerged that appear to be science-based and offer gene-level insights into your health. And these tests don’t even require a physician’s visit – just a swab...