FDA Issues Final Rule to Regulate LDTs: Bill Morice, M.D., Ph.D.

[@TheSensation19]

The ruling reads as though labs are now allowed to not ask for consent before givin them experimental treatments. Can you elaborate on that claim?

[@jfitzpatrick6108]

Does this mean it would be "illegal", i.e. a criminal offense for John Doe to possess PCR Grade Water or any other substance designated "RUO"?

[@mennowitteveen3313]

This profoundly saddens me. I was thinking of starting a company to use DNA sequencing to diagnose rare conditions. However this completely breaks the business model.