AABB Advocates for Balanced Regulation of Laboratory-Developed Tests

AABB joined a coalition of patient advocates, laboratory professionals and public health organizations to support appropriations report language directing the Food and Drug Administration to pause implementation of the final rule regulating laboratory-developed tests (LDTs) as medical devices and to collaborate with Congress on modernizing the regulatory framework for LDTs.  

In the letter, the organizations highlighted the critical role of LDTs in diagnosing and treating conditions such as cancer, rare diseases and infections. They also cautioned that FDA’s final rule would impose excessive financial burdens on laboratories and has the potential to stifle innovation and compromise patient care.