Skip to main content
Premium Trial:

Request an Annual Quote

GenDx Lands CE Mark for Sanger Sequencing HLA Typing Product Line

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.

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.