Moderator Scott Gottlieb, MD, asked John L. Fox, MD, MHA, what the FDA will regulate regarding the laboratory-developed tests (LDTs), and whether or not these regulations will improve the way the test is run or will affect the laboratory regulations.
“The truth in the matter is that is how a lot innovation in oncology has always unfolded. Local institutions that have expertise in one area promulgate the diagnostic test and use it responsibly. You wouldn’t want to shut that down,” Dr Gottlieb explained.
University-based research centers and programs will not stop using LDTs for their patients, Dr Fox said. However, the individual hospitals who spent millions and are doing their own analyses will get shut down because they cannot survive just performing on patients, he added.
Dr Fox then described the larger issues that the FDA faces in regulating LDTs. The first is the gap in the ability of most clinicians to take the test results and communicate it to their patients, and to use those results in clinical decision-making. There are companies out there that sell their services by interpreting LDT results and putting them in a format that physicians can understand and he considers this is the weak link as there is an inability to see how these tests are being used in the real world.
Dr Fox would also like for payers to be able to track outcomes for the patients. The European Union has an infrastructure that provides an overview that allows the collection of stage of information, and tracks illnesses, treatments, and outcomes. The United States does not currently have this system and Dr Fox does not expect the FDA will be the entity to fix that.
Dr Gottlieb predicted that what the FDA regulations would do is make it more difficult for these tests to come to market. Eventually, he expects, capital will become necessary to continue these tests, and in order to get this capital, the use case will need to be demonstrated and its data developed.