A Time for Reflection and Support for the FDA In times of hardship, silence can be deafening and disheartening. For decades, the U.S. Food and Drug Administration has stood as a pillar of public health – working tirelessly to ensure that the food we eat, the drugs we take, and the medical devices we rely […]

LDT Oversight: Let’s Fix the Gaps, Not Fight in Court I recently read a very interesting post using a “frozen dinner” vs “restaurant” metaphor to differentiate between in vitro diagnostic (IVD) test kits and laboratory developed tests (LDTs). (https://lnkd.in/gYv6ZHGJ). It suggests that IVD test kits are akin to frozen dinners (i.e., mass-produced with standardized instructions

The Hidden Risks of Poorly Validated Lab-Developed Tests: What Patients and Providers Need to Know With the recent court decision vacating the FDA’s rule on Lab-Developed Tests (LDTs), many laboratories will continue operating without additional federal oversight. While this may seem like a win for innovation and accessibility, it also raises serious concerns about test