AMP recommends regulations on lab developed tests to the FDA

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The Association for Molecular Pathology (AMP) has made recommendations to the FDA to review the oversight of laboratory developed tests (LDTs) as they continue to play essential and formative roles in delivery of preventative care, diagnosis and disease management.

Elaine Lyon, PhD, chair of the AMP professional relations committee, presented comments at the FDA's Center for Devices and Radiological Health public meeting on the oversight of LDTs in College Park, Md.

"AMP believes that LDTs are an essential and central component of medical practice. Without LDTs, the practice of medicine that we know today would be severely reduced in scope," Lyon said.
AMP believes that a regulatory model should not interfere with the practice of medicine, and there is a lack of review of current and proposed oversight models. In its remarks, the association encouraged the FDA to collect data and assess the effectiveness of existing oversight models prior to implementing new approaches, as it will be extremely important to demonstrate that any proposed oversight system would lead to improved health outcomes.

AMP said it believes that LDTs in all disciplines of laboratory medicine should be subject to the same oversight mechanisms, and that molecular or genetic tests should not singled out for heightened scrutiny simply due to the heritable nature of nucleic acids. AMP does agree that some tests may require greater scrutiny and may warrant additional regulatory review. However, Lyon expressed concern about the impact on low volume tests.

To advance the field of molecular pathology, any new oversight policy should also work to address the barriers to test development. Specifically, AMP believes the recognition and implementation of advances in medical research may be hindered by a lack of certified reference materials and encourages the government to support the development of these materials at the National Institute of Standards and Technology.

A major hurdle for laboratories is the reimbursement of diagnostic tests. Escalating costs for test development, performance, interpretation and reporting, compounded with additional costs to satisfy new regulatory requirements could result in the elimination of important clinical tests. In considering revisions to the current oversight processes, AMP urged FDA to realize the potential ramifications on test availability due to economic considerations.

Lastly, AMP recommended that the FDA convene an external advisory committee composed of individuals with expertise in the relevant diagnostic areas to assist in identifying the appropriate risk classifications.

"As the FDA considers its approach to regulating LDTs, AMP encourages the agency to consider the unanticipated effects that significant modifications to the current oversight system could represent for clinical laboratories," Lyon concluded. These unanticipated effects include the possibility that laboratories may be compelled to discontinue services and/or potentially lose flexibility to rapidly introduce and continually improve tests, all of which would adversely impact delivery of effective care to our patients.