Categories: "Medical and Research Devices"
Reference #: 2016-033
A kit and method for genotyping of both alleles of the glycosyltransferase gene controlling A, B and O antigens using “next generation sequencing”. HLA genotyping may also be performed in the same single run, thereby providing more complete information for use in donor selection matching for transplantations and transfusions.
A kit that is more rapid and provides more complete information for use in donor matching
selection for solid organ transplantations, blood and hematopoietic stem cell transfusions.
- Next-generation sequencing provides for routine separation of alleles and reduction of ambiguity, thereby allowing for more rapid donor selection
- Ability to combine two analytes, ABO and HLA, into one assay, thereby providing more complete information for use in the donor selection process
Methods of the invention can be used in multiplex format to process simultaneously, genomic DNA
from multiple individuals
A significant challenge for donor registries is how to identify the factors that are important for unrelated
donor selection in a rapid, cost effective manner. HLA assignment is the primary step in making this
determination, however there are thousands of HLA alleles and various polymorphisms that occur within
them, thus increasing ambiguity and necessitating secondary assays. Next-generation DNA sequencing separates alleles and reduces ambiguity. In addition to HLA testing, ABO typing must also be performed in the donor selection process. The present invention provides for both HLA and ABO allele analysis and typing in a single run.
STAGE OF DEVELOPMENT
Utility patent application pending