AdvaMedDx Statement on FDA LDT Draft Guidance

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AdvaMedDx Statement on FDA LDT Draft Guidance

September 30, 2014

Andrew Fish, executive director of AdvaMedDx, released the following statement regarding the release of draft guidance by FDA on the regulation of laboratory-developed tests (LDTs):

“AdvaMedDx appreciates FDA’s release of draft guidance on a risk-based approach to the regulation of LDTs and looks forward to reviewing and providing comments.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.”

For more information, please contact: Wanda Moebius @ (202) 434-7240