Guest:
Elaine Lyon, President, AMP; Director of Genetics Division, ARUP
Bio and Contact Info
Listen (5:53) How do you determine clinical validity?
Listen (5:41) Whole genome or exome?
Listen (5:41) LDPs not LDTs
Listen (5:40) Having both CLIA and FDA regulation too onerous
Listen (3:25) Not convinced that FDA cleared means a better test
Listen (2:32) Opting out of incidental findings
Elaine Lyon has become a key figure in genomic medicine. As the Medical Director of Molecular Genetics at ARUP Laboratories, she's at the bench developing clinically relevant genetic tests. Serving a term as President of AMP, or the Association for Molecular Pathology, she is a popular speaker on the diagnostics conference circuit and is certainly able to talk from an overall industry perspective. She joins us as part of our series Regulation and Genomic Medicine.
Beginning with questions about her work in the lab, the interview quickly moves on to Elaine's thoughts on regulation. Recently, Elaine co-authored a paper arguing that we should not be calling the tests laboratory developed tests, or LDTs, but rather laboratory developed processes, or LDPs. Her point is that the test is not the product, but rather the report that's delivered to the physician. She says we should be focusing on the process of genetic testing because a lot depends on the professionalism of the lab tech doing the test. As a process, Elaine continues her argument, the products are not actually in the domain of the FDA.
As guests have noted on this show before, the diagnostics industry has suffered from low quality testing. There are the three issues of analytic validity, clinical validity and clinical utility. It's been argued that regulation by the FDA can improve the quality of the testing. Elaine is doubtful of this argument.
"I am not convinced that simply having an FDA cleared test means it's a better test," she says.
She feels that more regulation is just too onerous. Rather than having two separate governmental regulatory bodies--CLIA and the FDA--examining and approving the testing, Elaine says that we should enhance CLIA.
Elaine warns that at a time when labs are not getting reimbursed like they used to, adding FDA regulation will increase the cost of genetic testing. This may mean that labs won't be able to offer these tests at a time when the technology is dramatically better.
We end with a discussion about the recommendations coming out of the recent ACMG meeting.
Podcast brought to you by: Myraqa Clinical Research: The CRO for Point of Care and PMA Diagnostics.
