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.
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