Immucor and Sirona Genomics Announce CE Mark for MIA FORA™ NGS HLA Typing Solution

Approval enables European HLA laboratories and those beyond Europe requiring CE mark to adopt differentiated Next Generation Sequencing (NGS) solution for HLA typing

10 Feb 2016
Lois Manton-O'Byrne, PhD
Executive Editor

Industry news

Immucor, Inc., a global leader in transfusion and transplantation diagnostics, in collaboration with Sirona Genomics, has announced CE Mark approval for its MIA FORA NGS offering for HLA typing.

“Since the launch of our MIA FORA NGS product last month, feedback from the HLA community has been overwhelmingly positive,” stated Michael Mindrinos, Ph.D., President and co-founder of Sirona. “With its manual and automated workflows, MIA FORA NGS is a versatile offering that can be used in HLA laboratories large or small. We are excited to be working with Immucor and HLA laboratories around the world to help bring the improved resolution from next generation sequencing to stem cell and solid organ typing.”

MIA FORA NGS is a high resolution HLA typing solution that enables accurate, comprehensive coverage and analysis of 11 HLA genes. The offering, which is adapted for use on the Illumina MiSeq® NGS platform, can be automated or run manually.

“European regulatory clearance is a significant milestone for MIA FORA NGS and is the result of strong teamwork between Immucor and Sirona Genomics,” stated Keith Chaitoff, Immucor’s Chief Marketing Officer. “We believe MIA FORA NGS is a differentiated product that is improving patient outcomes by helping to provide transplant recipients with better matched stem cells and solid organs. We are excited to now be able to offer this product to our customers requiring CE mark.”

Today’s announcement follows the worldwide launch of MIA FORA NGS in December 2015. A higher volume test kit for registry HLA typing is expected to launch this year. MIA FORA is available RUO in the U.S.

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ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.Next Generation SequencingNext-generation sequencing (NGS), also known as whole-genome sequencing, high-throughput sequencing and massive parallel sequencing, produces and analyses thousands to millions of nucleotide sequences at once. Sequencing systems operate via varying technologies depending on the manufacturer, including sequencing by synthesis, ligation, pyrosequencing, ion semiconductor and single-molecule real-time sequencing. For NGS, library preparation is paramount to successful sequencing. In this section, explore a range of library preparation kits, from targeted, amplicon-based or hybridization-based kits including epigenomic, transcriptomic and genomic workflows to fragmentation kits. Find the best next-generation sequencing products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.ImmunophenotypingStem Cell ResearchStem cells have the ability to produce identical daughter cells as well as progeny, which commit and differentiate. Stem cell research has exciting prospects of biomedical applications in cellular disease modeling, pharmaceutical screening, and regenerative medicine.