The Food & Drug Administration has undertaken a major update of its approach to regulating clinical diagnostic tests. Under the new rules, Lab Developed Tests (LDTs) will now be regulated as “devices” and required to undergo pre-market review. (Image: Elenabsl/Shutterstock)
The
Food and Drug Administration has issued new rules aimed at bolstering the
agency’s oversight and regulation of the diagnostic testing field.
Specifically,
the FDA is taking aim at Laboratory-Developed
Tests (LDTs),
which are defined as in vitro medical tests designed, manufactured, and
processed by a single clinical laboratory. Historically, LDTs were unique,
highly targeted tests developed within large hospital systems for use solely
within those systems. More recently, however, many LDTs have entered the market
for wider commercial use.
Under
prior rules established in the late 1970s, the FDA took a lenient “general enforcement discretion” approach to LDTs. That meant these tests were not subject to pre-market
approval, nor to the more intensive scrutiny the agency applies to medical
devices and test methods intended for more general use in diverse clinical
settings.
The statistics have been clear and consistent for decades: autoimmune conditions are at least three times more common among women than men. Some studies suggest it’s more like a factor of four. For specific diseases like Lupus, the disparity is 9-fold. For Sjogren’s syndrome, it’s 19 to 1. This appears to be an objective biological […]
The presence of micro- or nano-plastic particles in carotid atheromas significantly raises the risk of myocardial infarction, stroke, or death from any cause within 3 years. That’s the blunt conclusion of a new multi-center study headed by researchers at the Department of Advanced Medical & Surgical Science, University of Campania, Naples, and involving more than […]
Risk assessment is a foundation of good clinical
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Joel Evans, MD, is Chief Medical Officer at geneType, and is a board-certified OB/GYN and international lecturer. He is the Director of The Center for Functional Medicine in Ridgefield, CT, and Chief of Medical Affairs for the Institute for Functional Medicine. Dr. Evans is renowned for his passion for mind-body medicine. His special interest in breast cancer led him to serve as the Medical Director of the Keep A Breast Foundation. Dr. Evans brings decades of applied research about cancer risk and prevention to his patients, and to the functional medicine community.
