Andrew Fish, executive director of AdvaMedDx, issued the following statement on today’s House Energy & Commerce Health Subcommittee hearing on the regulation of diagnostic tests and laboratory operations:
“Diagnostic tests are a cornerstone of modern health care, advancing personalized medicine and driving patient care at all stages – from initial diagnosis and prognosis to treatment and follow up. AdvaMedDx commends Health Subcommittee Chair Joe Pitts (R-Pa.) and Ranking Member Gene Green (D-Texas) for holding today’s hearing on ensuring effective regulation of these vital medical technologies.
“Diagnostic tests present the same risks for patients regardless of where they are developed and must be regulated accordingly. Whether developed by a manufacturer or a laboratory, increasingly complex tests are playing a more and more crucial role in health care decision-making by patient and physicians. The FDA’s role in ensuring the accuracy and reliability of all diagnostic tests – as it does now for tests developed by manufacturers – is more important than ever.
“Serious patient harm can arise from reliance on test results that do not have the accuracy or clinical relevance claimed by their developer, including unnecessary treatments, with their accompanying costs and side effects; treatment delays; and even failure to obtain appropriate treatment.
“FDA oversight of all diagnostics tests – under a risk-based framework – is crucial to ensuring patient safety, and FDA is the only agency with the current regulatory appropriate expertise and resources to provide effective oversight of this rapidly evolving area of health care. Proposals to create a new regulatory system at CMS dedicated solely to laboratory developed tests would duplicate resources, perpetuate disparate treatment of similar tests, and create additional confusion for patients and physicians.
“We commend FDA for its work in developing its draft guidance on regulation of laboratory developed tests, which emphasizes the importance of a risk-based approach.
“AdvaMedDx looks forward to working with Congress, FDA, patient and physician groups, the laboratory community, and all stakeholders to implement a risk-based regulatory approach to all diagnostics that supports new advances in technology and promotes patient care by supporting timely access to innovative tests.”