For a long time now I have been pushing FDA to provide evidence to back up its claim that LDTs have introduced risk to patient populations. That evidence has now been provided, and it is compelling.

FDA has just published a case for LDT regulation based on 20 case studies of patient risks due to poor performing LDTs. I have yet to review the report in detail, but the initial scan seems to make a strong case for greater regulatory oversight of LDTs.