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Wanda Moebius
July 31, 2014

AdvaMedDx Commends FDA's Issuance of LDT Draft Framework

WASHINGTON, D.C. – Andrew Fish, executive director of AdvaMedDx, released the following statement regarding FDA’s congressional notification and draft framework on the regulation of laboratory-developed tests (LDTs):

“AdvaMedDx welcomes the publication of the draft framework on a risk-based approach to the regulation of LDTs and looks forward to reviewing the draft guidance when it is issued. These types of tests are increasingly being used to diagnose and guide the treatment of potentially life-threatening conditions, and FDA oversight of higher risk 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 and flexible approach to the review process for diagnostics. Such a review process should create a reasonable pathway to market and advance patient care by promoting timely access to innovative technologies.

“We look forward to working with FDA to address this important public health matter, and together with our members, we will provide substantive comments on the draft guidance after it is published to help ensure the development of an efficient regulatory process for all diagnostics that supports patient access to safe and effective tests.”


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.