Monday, April 1, 2024

FDA LDT Rule: ASM Weighs In (Amer. Soc. Microbiology)

At multiple points in the current FDA-LDT regulation process, American Society of Microbiology has weighed in with serious concerns.  Here's the latest, from March 18, 2024.   (See right sidebar at the webpage for more ASM links).

ASM writes in part,

  • From tuberculosis to dengue to malaria, we have no option but to use LDTs to detect pathogens of major public health importance. In the era of growing antimicrobial resistance, our reliance on LDTs to detect highly antibiotic-resistant superbugs will only increase. 

  • The FDA’s proposed rule will erode our capacity to respond to emerging pathogens or even the next pandemic—and it will come at a time when we need more, not less, front-line innovation. In our work, we’ve long seen LDTs at the leading edge of patient care, whether it’s life-or-death diagnoses, outbreak containment or access to testing.