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Mark E. Brager
September 30, 2014

AdvaMedDx Statement on FDA LDT Draft Guidance

WASHINGTON, D.C. – Andrew Fish, executive director of AdvaMedDx, released the following statement regarding the release of draft guidance by FDA on the regulation of laboratory-developed tests (LDTs):

“AdvaMedDx appreciates FDA’s release of draft guidance on a risk-based approach to the regulation of LDTs and looks forward to reviewing and providing comments. LDTs are increasingly being used to diagnose and guide the treatment of potentially life-threatening conditions. FDA’s risk-based oversight of diagnostic tests – including companion diagnostics, regardless of the manufacturer – is essential to patient safety. A number of patient groups and professional societies have expressed concern regarding the current lack of FDA oversight in this area.

“AdvaMedDx’s membership supports a modernized risk-based approach to the review process for diagnostics. Such a review process can support new advances in technology and promote patient care by supporting timely access to innovative technologies.”


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.