The announcement in 2012 by the Food and Drug Administration (FDA) that they were concerned about the safety of laboratory-developed tests (LDTs) and intended to exercise regulatory authority created a great degree of uncertainty in the various Clinical Laboratory Improvement Amendments (CLIA)-certified labs, which in some cases were deriving the bulk of their income from such testing. This was followed in 2014 with a proposed framework for regulation of these tests and the entities offering them to patients. While this issue is still in the comment phase at the time of this writing, it seems certain based on the nature of comments received so far that stricter regulation of LDTs poses a potential for significant cost to many laboratories offering these tests.

This scenario also illustrates the need to be engaged in the advocacy process and to adroitly choose partnerships in the process to be effective. The various alliances in the health-care world in this debate may include various patient safety groups, the drug and pharmaceutical companies with FDA-approved or in the pipeline companion diagnostic tests (CDTs), the digital pathology companies and other novel device companies whose equipment has been operating under the LDT framework for various purposes, the large reference labs serving multiple institutions as well as smaller labs primarily serving single institutions, and the physicians operating the labs and receiving results therefrom. Also in the picture is the entity that has previously been the sole regulatory gate in the LDT process—Centers for Medicare/Medicaid Services (CMS) with CLIA certification.