Each day the Mayo Clinic Diagnostic lab receives thousands of biological specimens from all over the country. These are then sorted and tested for a variety of health conditions, the results of which inform doctors which course of actions to take for their patients.
Labs like Mayo have been performing and reporting results for hundreds of diagnostic tests. But the FDA may further scrutinize this process in the future for all US laboratory developed tests (LDTs). This change was largely brought on by a recent report of 20 case studies in which LDTs from around the country did not meet FDA requirements.
While well intentioned, Mayo and other diagnostic labs argue new FDA proposed regulations would create a huge backlog during the review process. They are concerned that this could severely hinder medical testing and innovations.
Ultimately, any decision should be guided by what's most beneficial to patients. How this will unfold is still to come.