Sandra Rosen-Bronson - Comment

I STRONGLY URGE YOU TO RECONSIDER THE DECISION TO DO AWAY WITH OR STRINGENTLY REGULATE THE USE OF LDTs AT A NATIONAL LEVEL. As a health care professional I appreciate the mission and dedication of the FDA. However, I feel that patients needing solid organ or stem cell transplantation would suffer immeasurably should FDA oversight be extended to those LDTs used to judge the compatibility of donor-recipient pairs. The fields of histocompatibility and immunogenetics have been at the forefront of translational research and medicine since the 1960s. Tests were developed for typing of histocompatibility antigens (HLA), detection of anti-HLA antibodies in patient serum, and crossmatching of donors and recipients to determine compatibility. The flexibility to adapt tests and reagents into the histocompatibility field and validate them against clinical outcome has enabled LDTs to become the engine that drives transplantation today. The NOTA 2005 Final Rule gave several mandates to the transplant community and through the accuracy and efficiency provided by these LDTs, most of these mandates have been met. Without the flexibility to adapt research-use tests into clinical laboratory assays, the major advancements achieved in organ allocation, diagnosis of rejection, and improved graft survival would not have occurred. The transplant community recognizes the need for standards and guidelines for developing and using LDTs and the agencies that accredit histocompatibility labs have stringent guidelines for their use in patient care. To penalize the off-label use of reagents as LDTs would remove any incentive a vendor or laboratory would have in developing tests for transplant patient management. It would undo the progress we have made in transplanting the most sensitized patients and improving the efficiency and equitability of organ allocation.