America’s Blood Centers (ABC) is advocating for Congress to allow a blood center LDTs exemption in LDTs regulations. Specifically, ABC has submitted comments in response to the request for information (RFI) for reforms to diagnostics regulation from Sen. Bill Cassidy, MD (R-La.), ranking member of the Senate Committee on Health, Education, Labor, and Pensions. The blood center LDTs exemption comment letter from ABC urged that an exemption for laboratory developed tests (LDTs) used by blood centers should exist to exclude such LDTs, “from any reforms to diagnostics regulation since these tests do not fall within the categories of laboratory services and diagnostic products that Congress and FDA are looking to regulate.”
The blood center LDTs exemption comments explained that, “[b]lood centers have significant safeguards in place when developing and utilizing LDTs. Their laboratories work within the Clinical Laboratory Improvement Amendments (CLIA) regulations to create the reagents and procedures. Additionally, blood center laboratories ensure the quality and validity of tests through the existing regulatory framework and safeguards.” ABC also stated in the blood center LDTs exemption comments that, “LDT procedures in blood centers are already highly regulated. They are usually performed in urgent, life-saving situations and are always performed for patients being treated in a healthcare setting. Given the oversight and inspection already in place for blood centers, adding an additional layer of regulation is unnecessary.”
The blood center LDTs exemption RFI response from ABC described how safe and effective, “[b]lood centers’ LDTs are.” ABC also noted in the blood center LDTs exemption comments, “the importance of ongoing efforts to mass screen donors as part of several LDT Red Cell Genotyping (RCG) platforms used by blood centers across the country. These RCG platforms are able to provide more targets for rare blood groups…Without the ability to mass screen donors for these rare blood types, blood centers would not be nearly as successful as they are today in finding the right blood for these patients with difficult transfusion requirements.”
ABC concluded the blood center LDTs exemption comments by explaining that, “[i]f blood centers’ LDTs are included in reforms to diagnostics regulation, there will be significant patient harm due to delays in care and the lack of patient access to medically necessary tests…The unique nature of a biologic substance taken from a donor can sometimes require extensive matching to ensure a recipient patient does not have a dangerous transfusion reaction. If these tests are unavailable, physicians must still make a prompt decision about the transfusion, and they will have less information available to them to determine the safest course of action. Suppose blood centers are required to follow the proposed regulatory framework for LDTs. In that case, many of these tests will not be available, and/or patient access to the tests will be seriously delayed, potentially causing significant patient harm.”
ABC will continue to provide updates of its advocacy efforts on this issue. An archive of all ABC letters and comments is also available.
The RFI and Congressional interest in the regulation of LDTs comes in response to the September 2023 U.S. Food and Drug Administration’s (FDA) Laboratory Developed Tests (LDTs) proposed rule. ABC previously submitted comments to the LDTs proposed rule in December 2023.