Advisory Committee on Organ Transplantation

U.S. Department of Health and Human Services

Recommendations 53 & 54

The Advisory Committee on Organ Transplantation (ACOT) met on August 23-24, 2011, in Washington, DC, and unanimously agreed on the following two recommendations:

Recommendation 53: The ACOT recommends that the Secretary redefine Vascularized Composite Allografts (VCA) as “organs” under the National Organ Transplant ACT.

Recommendation 54:  The ACOT recommends to the Secretary that the FDA recognize and accept laboratory-developed testing performed in CLIA-certified, high-complexity histocompatibility laboratories.

Background
The ACOT concludes that the FDA’s investigational-use-only (IUO) and research-use-only (RUO) guidance document for laboratory-developed testing has serious unintended consequences for the field of transplantation, including:

• Reduced access to transplantation for sensitized candidates
• Reduced deceased donor availability for non-renal candidates without “virtual crossmatches”
• No desensitization or post-transplant monitoring except on research protocols
• The inability to provide high-resolution matching for HSCT transplantation