Donna P Lucas - Comment

The fields of histocompatibility and immunogenetics have been at the forefront of translational research and medicine since the 1960s. Serological 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. All of these tests used reagents originally intended for research. Over time, it was shown by clinical studies that more sensitive techniques were needed. The ensuing research which focused on finding more sensitive and accurate technologies wouldn’t have been possible if researchers had not been allowed to adapt Research Use Only reagents and kits (RUO’s) and Analyte Specific Reagents (ASR) to solve specific problems in determining transplant compatibility and then translate them into actual patient care. The flexibility to adapt tests, reagents, and observations from the literature into the histocompatibility field and then validate them against clinical outcome has enabled LDTs to become the engine that drives solid organ and stem cell transplantation today. Techniques such as flow cytometry, polymerase chain reaction, DNA sequencing, and microbead array assays have given laboratories the ability to determine the best possible donor for a recipient and give that recipient the best possible chance for a successful transplant and increased life expectancy. Again, none of these LDTs were initially developed for the transplant community but their potential for transplant patient care was seen and they were adapted for use in histocompatibility testing. In order to accomplish this, the LDTs had to be validated in accordance with the rigorous guidelines and standards of laboratory accrediting agencies. Without the flexibility to adapt and develop research-use tests into clinical laboratory assays, the major advancements would not have occurred. I respectfully urge you to reconsider the decision to stringently regulate LDTs.