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Danielle Blake
September 20, 2016

AdvaMedDx Statement on Senate HELP Committee Diagnostic Test Hearing

WASHINGTON, D.C. – Andrew Fish, executive director of AdvaMedDx, issued the following statement on today’s Senate HELP Committee hearing on laboratory testing in the era of precision medicine:

“AdvaMedDx commends the Senate HELP Committee for holding today’s hearing on ensuring effective regulation of diagnostic tests, particularly laboratory-developed tests (LDTs). As a cornerstone of modern health care, diagnostics support effective and efficient patient care and are advancing precision medicine.

“To ensure consistent and effective oversight of all diagnostics, AdvaMedDx supports FDA oversight of tests developed by both manufacturers and laboratories under a risk-based approach that promotes public health and innovation. FDA oversight is essential to ensuring that all diagnostic tests – including LDTs – are subject to premarket review, required demonstration of clinical validity, systematic adverse event reporting and other critical regulatory safeguards.

“As diagnostics have increased in complexity and become even more integral to decision making in the treatment of patients with serious and life-threatening diseases, it is even more important to close the regulatory gap between tests developed by manufacturers and those developed by laboratories. Inaccurate and insufficiently validated tests can pose serious harm to patients and the public health, including unnecessary treatments, with their accompanying costs and side effects; treatment delays; and even failure to obtain appropriate treatment.

"AdvaMedDx supports congressional efforts to improve oversight of LDTs, as well as FDA exercising its authority to finalize long-awaited guidance in this area, which should not be precluded by legislative action. Delay in finalizing a regulatory oversight framework for LDTs does not benefit patient safety or innovation. We stand ready to engage with all stakeholders in exploring ways to improve oversight of all diagnostics which are a cornerstone of modern medicine."