A Joint Statement Presented Before the Food and Drug Administration's Blood Products Advisory Committee
18 March 2014
The Immucor PreciseType™ HEA Molecular BeadChip, and Similar Assays
M. Allene Carr-Greer, director, Regulatory Affairs, AABB
The use of molecular testing for red cell, platelet, and neutrophil genotypes to provide a molecular phenotype has been a part of the blood community for a number of years. The first edition of Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens was published by AABB in the fall of 2008 and became effective on July 1, 2010. The second edition is now in effect. Standards were developed recognizing that testing is performed with the use of non-licensed assays – Research Use Only (RUO) and laboratory developed tests (LDTs). These assays substantially improve our ability to serve a large and complex population of recipients, especially the chronically transfused and alloimmunized, for example sickle cell disease patients. The expeditious availability of licensed assays will add a layer of quality assurance that is currently lacking.
AABB, the American Red Cross and America's Blood Centers worked together on the AABB Workgroup on Labeling with Historical Antigen Typing Results. We presented a statement at the December 2012 BPAC on Labeling of Red Blood Cell Units with Historical Antigen Typing Results. This interorganizational workgroup looked at the clinical utility of molecular and serological testing, how these test methods are often complementary and explicitly recognized that resource conservation – driven by the absence of, expense for and frequently poor quality and/or specificity of antisera – dictates the wide use of unlicensed molecular assays in current clinical practice.
Today you have heard a discussion of several issues related to the Immucor PreciseType™ HEA Molecular BeadChip Assay, manufactured by BioArray Solutions LLC. Our comments are not particular to this assay; they relate to issues that need to be addressed as the Immucor product, and other similar assays are licensed for use in blood center and transfusion service laboratories.
The following issues are important.
How will the availability of a licensed assay affect the ability of establishments to use LDTs and commercial RUO assays?
- The road to licensure has been a long one and we anticipate it will be some time before all establishments have the option of using a licensed assay. LDTs and RUOs must remain acceptable for use while other assays are being brought forward.
- LDTs must remain an acceptable option for the investigation of unusual alleles that will likely not be immediately available on FDA-approved commercial platforms.
We do not believe there should be a requirement for confirmation of the results from a licensed molecular phenotyping system with alternate assays/methods on an index sample.
- The results of a licensed assay should stand on its own merit as do the results of licensed serologic reagents.
- As mentioned previously, the group of experts who worked on the interorganizational labeling workgroup were motivated in large part by scarce resources that were being used to retype all subsequent donations from repeat donors.
Licensed assays should have appropriate claims (clarity in labeling), inclusive of limitations and exceptions, similar to information provided in package inserts of licensed serological reagents. Data should be made available on the frequency of discrepancies between genotype-predicted phenotype and serologic phenotype and their resolution.
AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries
Founded in 1962, America's Blood Centers is North America's largest network of community-based, independent blood programs. The network operates more than 600 blood donor centers providing over half of the U.S., and a quarter of the Canadian blood supply. These blood centers serve more than 150 million people and provide blood products and services to more than 3,500 hospitals and healthcare facilities across North America. America's Blood Centers' U.S. members are licensed and regulated by the U.S. Food and Drug Administration. Canadian members are regulated by Health Canada.
The American Red Cross shelters, feeds and provides emotional support to victims of disasters; supplies about 40 percent of the nation's blood; teaches skills that save lives; provides international humanitarian aid; and supports military members and their families. The Red Cross is a not-for-profit organization that depends on volunteers and the generosity of the American public to perform its mission. About 5.6 million units of whole blood are collected from roughly 3.3 million Red Cross volunteer donors, separated into 8 million transfusable blood products and supplied to approximately 2,700 hospitals and transfusion centers across the country for patients in need.