By Howard Coleman, Genelex CEO
The week of May 9 saw scores of scientists, researchers and clinical laboratory professionals descend on the nation’s capital for the annual American Clinical Laboratory Association (ACLA) conference.
ACLA serves as a voice in Washington D.C. for clinical laboratories nationwide. A key topic of this year’s conference was the U.S. Food and Drug Administration’s (FDA) initiative to regulate laboratory developed tests (LDT), like the ones Genelex provides, as “medical devices.”
Legal and other experts representing ACLA have expressed strong doubts about the FDA’s authority to regulate LDTs. At Genelex, we stand with them. We believe the FDA’s regulatory authority does not apply to laboratory-developed tests (LDTs) and that moving forward with such regulation as we currently understand it would be expensive, limit accessibility to these tests and harm patients.
We welcome efforts by the FDA to improve their regulatory processes, but such improvements must be based on strong evidence for a problem. For example, the FDA needs to provide a similar level of evidence for the basis of their concerns with LDTs as they would expect when presented with novel medical technologies or treatments.
Secondly, we encourage the FDA to do a cost-benefit analysis to determine if regulating LDTs as they propose will be worth the potential limitations new rules could place on LDT accessibility. This ought to be taken into consideration, given that well-respected organizations, such as the College of American Pathologists, already set standards for such testing.
As ACLA president Alan Mertz wrote earlier this year:
“LDTs are regulated under a strict and comprehensive framework that also allows laboratories to develop tests quickly and to update them regularly as research and medicine advances, giving patients access to the most current diagnostic testing available. Diagnostic innovation and improved patient outcomes, which have thrived under the current regulatory framework, would be threatened by the FDA device regulatory framework.”
We applaud the work of the U.S. Senate Committee on Health, Education, Labor and Pensions, which oversees the FDA, and encourage them to make LDT regulation discussions a priority.
Howard Coleman co-founded Genelex in 1987 and serves as chairman and CEO. He holds a BS in clinical science and a BA in psychology and studied at the University of Washington and Fred Hutchinson Cancer Research Center.
