NEW YORK (GenomeWeb) – GenDx has obtained CE-IVD certification for its entire AlleleSEQR product line for human leukocyte antigen (HLA) typing.
AlleleSEQR uses PCR amplification and Sanger sequencing to test for several types of HLA genes that are involved in immune response and have bearing on stem cell or organ transplant success or rejection. There are test kits for HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1.
The Utrecht, Netherlands-based firm said in a statement that getting the CE-IVD certification is the final step of acquiring the AlleleSEQR product line from Quest Diagnostics subsidiary Celera Genomics, a process begun in May 2015. As of Jan. 1, GenDx is fully responsible for manufacturing, distributing, and supporting all AlleleSEQR products worldwide.
"An important part of CE-marking process was to demonstrate that AlleleSEQR products manufactured by GenDx have equivalent performance as the products previously manufactured by Celera," the firm said in a statement. "On request, the validation report is available for end users."
The firm also said it has made agreements with the firms that provide the subcomponents of the kits, including Roche, Affymetrix, and Thermo Fisher Scientific's Life Technologies.