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. 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.” About Illumina Illumina ( www.illumina.com) is a leading developer, manufacturer, and marketer of life science tools and integrated systems for the analysis of genetic variation and function. We provide innovative sequencing and array-based solutions for genotyping, copy number variation analysis, methylation studies, gene expression profiling, and low-multiplex analysis of DNA, RNA, and protein. We also provide tools and services that are fueling advances in consumer genomics and diagnostics. Our technology and products accelerate genetic analysis research and its application, paving the way for molecular medicine and ultimately transforming healthcare. About HistoGenetics, LLC HistoGenetics ( www.histogenetics.com) is the global leader in HLA sequence-based typing (SBT). As a pioneer the field, the company has provided its services for donor registries, donor centers, cord blood typing, transplant centers, HLA laboratories and pharmacogenomics applications. To date, HistoGenetics has performed more than 13 million SBTs and discovered 16,000 samples carrying new alleles. The company was founded by Dr. Soo Young Yang, who serves as Chairman, and Dr. Nezih Cereb, Chief Executive Officer. Forward-Looking Statements This release may contain forward looking statements that involve risks and uncertainties. Important factors that could cause actual results to differ materially from those in any forward-looking statements are detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We do not intend to update any forward-looking statements after the date of this release.