HistoGenetics selects MiSeq sequencing system from Illumina for use in CLIA laboratory

Illumina, Inc. (NASDAQ:ILMN) today announced that HistoGenetics, the leader in high-resolution sequence-based human leukocyte antigen (HLA) testing services, has selected the MiSeq sequencing system for use in its CLIA laboratory. HistoGenetics will deploy multiple MiSeqs to supplement its existing Sanger sequencing workflow to sequence HLA genes with high accuracy and speed. In addition to their utility in tissue matching for transplants, HLA gene variations have known associations with a wide variety of autoimmune diseases, infectious diseases, and some cancers.

“We anticipate building on our leadership position and established success by leveraging the MiSeq platform”

Despite their importance, HLA genes have not been routinely typed at higher resolution because of the technical challenges of accurately discriminating between these highly related genes and their many alleles. HistoGenetics, one of the largest HLA typing laboratories in the world, has previously implemented Sanger sequencing as the sole method for higher resolution HLA typing. With its deployment of MiSeqs, HistoGenetics will lead the transition from Sanger sequencing to next-generation sequencing for HLA typing.

"We anticipate building on our leadership position and established success by leveraging the MiSeq platform," said Dr. Nezih Cereb, Chief Executive Officer and Co-founder of HistoGenetics. "Based on our experience with other technologies, we think the MiSeq's quality data output and simple workflow, combined with Illumina's commitment to work collaboratively, is the ideal solution to enable us to provide our customers with the superior results and turnaround time they require."

HistoGenetics currently provides two levels of resolution with HLA sequencing-based testing, including high-level and registry-level resolution. At high resolution, the most comprehensive level, all ambiguities are resolved in the antigen recognition sites, and new and rare alleles missed by other methods typically can be found. The American Society for Histocompatibility and Immunogenetics and the National Marrow Donor Program require this level of testing for stem cell transplants. At the registry level, which is used for unrelated donor registries (such as the Be The Match Registry^TM) and cord blood banks, a majority of ambiguities are resolved.

"By introducing the MiSeq, we will be able to provide gold-level high resolution typing to pre-transplant work-ups, as well as to registry donors, and improve the turnaround time for sample processing," added Dr. Cereb.

HistoGenetics' turnaround time for typing services is currently as short as three days for urgent samples. To date, HistoGenetics has typed more than 3 million samples and performed more than 13 million sequence-based typings that led to the discovery of more than 16,000 samples carrying a new variant of an HLA allele.

"Next-generation sequencing has the potential to transform HLA genotyping, and we believe Illumina's technology is well-positioned to help drive that change," said Matt Posard, Senior Vice President and General Manager of Illumina's Translational and Consumer Genomics business. "The MiSeq can make a significant difference in terms of accuracy and speed for production-scale HLA typing. We look forward to a successful relationship with HistoGenetics."