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
NORCROSS, Ga., February 3, 2016 – Immucor, Inc., a global leader in transfusion and transplantation diagnostics, in collaboration with Sirona Genomics, today 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.
About MIA FORA NGS
MIA FORA, which roughly translates from Greek to “once,” allows HLA laboratories to achieve high resolution matching with no need for secondary testing to resolve ambiguities – results in one pass. The MIA FORA NGS sample preparation kit for long-range PCR and library preparation is user friendly with all-in-one master mixes, one PCR set up protocol, one amplification condition for all genes and a unique gene balancing program. Users also have the option to automate front end sample handling – the only one system to offer this labor efficiency with a benchtop footprint, which also helps to reduce manual errors and optimize patient results.
MIA FORA NGS provides superior whole gene coverage of all major HLA gene regions, including whole gene coverage for HLA-A,B, C, DPA1, DQA1, and DQB1; all exons and introns for HLA-DRB1,3,4,5 except partial coverage for exon 6 and intron 1; and all exons and introns between exons 2 and 4 for HLA-DPB1.
The MIA FORA NGS analysis software is uniquely built from the ground up specifically for HLA NGS typing. With an intuitive user interface, the MIA FORA NGS software is the only available product using three algorithms for accurate genotyping calls, a proprietary database for accurate mapping and alignment, and a smart flagging system that enables users to make accurate allele calls rapidly.
About Sirona Genomics
Sirona Genomics was spun out of the Stanford Genome Technology Center (SGTC) at Stanford University with a focus on developing next generation sequencing typing applications specifically for the HLA System. Based in Mountain View, CA, the company was founded by Ron Davis, Ph.D., Director of the SGTC and Professor of Biochemistry and Genetics at Stanford University; Mark Davis, Ph.D., Director of Stanford Institute for Immunity, Transplantation and Infection, and Professor of Microbiology and Immunology at Stanford University; Michael Mindrinos, Ph.D., former Associate Director of the SGTC; Marcelo Fernández-Viña, Ph.D., Professor for the Department of Pathology at Stanford University Medical School, co-Director of the Histocompatibility, Immunogenetics and Disease Profiling Laboratory at Stanford University; Sujatha Krishnakumar, former Life Science Research Associate at SGTC; and Chunlin Wang, former Senior Research Scientist at SGTC.
Founded in 1982, Immucor is a global leader in transfusion and transplantation diagnostics that facilitate patient-donor compatibility. Our mission is to ensure that patients in need of blood, organs or stem cells get the right match that is safe, accessible and affordable. With the right match, we can transform a life together. For more information on Immucor, please visit our website at www.immucor.com.