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Mark E. Brager
January 8, 2015

AdvaMedDx Statement on FDA LDT Public Workshop

Risk-based Approach Will Support Innovation, Patient Safety

WASHINGTON, D.C. – Andrew Fish, executive director of AdvaMedDx, issued the following statement today on FDA’s public workshop on a Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs):

“AdvaMedDx commends FDA for holding this meeting and gathering stakeholder comment on the appropriate regulation of LDTs. These increasingly complex tests are playing a more and more crucial role in health care decision-making by doctors and patients, and it is vital that FDA take steps to ensure their safety and effectiveness.

“Current oversight of laboratories by the Centers for Medicare and Medicaid Services (CMS) under CLIA – the Clinical Laboratory Improvement Amendments of 1988 – is not a substitute for FDA regulation that assures the safety and effectiveness of diagnostic tests. Many critical features of FDA oversight have been absent for LDTs under the CLIA laboratory program, and only FDA has the appropriate expertise and resources for necessary oversight of LDTs.

“AdvaMedDx and its member companies support a risk-based approach to FDA regulation of LDTs. LDTs are increasingly being used to diagnose and guide the treatment of potentially life-threatening conditions. We believe FDA oversight of diagnostic tests – including companion diagnostics, regardless of the manufacturer – is essential to patient safety.

“This view is shared by a number of patient groups and professional societies that have expressed concern regarding the current lack of FDA oversight in this area.

“A test presents the same risk for patients regardless of whether it is developed by a manufacturer or a laboratory. Potential harms to patients whose tests return incorrect results include unnecessary treatments, with their accompanying costs and side effects, treatment delays, and even failure to obtain appropriate treatment – all of which present concerns for patient care.

“The current diagnostics oversight paradigm results in a tremendous public health gap and highly disparate treatment of tests that are the same from the perspective of patient risk and safety, simply on the basis of where they are developed. This is bad public policy, provides an opportunity to use tests in clinical settings that have insufficient clinical data, and stifles investment in high quality products that are assured to be safe and effective for patients.

“AdvaMedDx looks forward to working with FDA, patient and physician groups, the laboratory community and all stakeholders to implement a regulatory approach to LDTs that supports new advances in technology and promotes patient care by supporting timely access to innovative tests.”

A copy of Andy Fish’s prepared remarks for the FDA LDT meeting are available here.


AdvaMedDx member companies produce innovative, safe and effective in vitro diagnostic tests that facilitate evidence-based medicine, improve quality of patient care, promote wellness, enable early detection of disease and reduce overall health care costs. Functioning as an association within AdvaMed, AdvaMedDx is dedicated to the issues facing in vitro diagnostic companies both in the United States and abroad.