Big Changes for Molecular Diagnostics as FDA Moves on Lab Developed Tests
By Aaron Krol
September 23, 2014 | Nearly two months have passed since the FDA announced its intention to start regulating laboratory developed tests, or LDTs, by mid-2015. These tests, which are designed, made and performed entirely in a single laboratory, have a huge footprint in the American healthcare system, and have often been on the front lines of innovation in areas like personalized medicine and cancer diagnostics. They are also the only in vitro diagnostic tests, or IVDs, that aren’t required to submit data to the FDA proving their safety and accuracy, although the labs that perform them do need to be certified under the Clinical Laboratory Improvement Amendments (CLIA).
In the nearly forty years that LDTs have enjoyed this policy of “enforcement discretion,” they have grown from a small but vital niche used mainly by hospital labs to diagnose rare diseases, to an industry where big players like Myriad Genetics and Genomic Health can post profits in the hundreds of millions of dollars. Conventional IVD manufacturers have been crying foul, and the FDA agrees that its LDT policy has led to some perplexing outcomes. “It certainly calls into question why a company would go through the entire regulatory process, if they can just open their own clinical lab,” says Katie Serrano, from the FDA’s Office of In Vitro Diagnostics. “And we’ve seen cases where they have done exactly that. The larger manufacturers have said, to heck with this PMA [premarket approval] process, we’re just going to open our own CLIA lab.”
At the same time the FDA declared that enforcement discretion was coming to a close, it also released an oversight framework explaining what it will require of labs that run LDTs, and the timeline for implementation. (For details of the proposed regulations, see “FDA Announces Plans to Regulate Laboratory Developed Tests.”) As mandated by Congress, the FDA has extended 60 days’ notice before officially issuing this framework as a draft guidance, but that period ends on September 29, and so far, the document appears likely to be issued more or less as written.