Holotype HLA Now CE-IVD in Europe - Omixon

Omixon announce today that Holotype HLA™ has been approved as a CE Marked IVD for sale in Europe, and will be available from April 2016 to all European customers as IVD, while remains RUO in the USA. Holotype HLA is the most globally recognized Next Generation Sequencing (NGS) Assay and Software combination product for the Illumina® MiniSeq, MiSeq and NextSeq that provides the most accurate high-resolution genotyping available in a single pass with no reflexive testing.

“While other companies either have no CE Mark or have only approved components of their NGS workflow, Omixon set out to CE Mark the entire combination product of assay and software as an IVD in Europe” says Omixon’s CEO Tim Hague. Additionally, Mr Hague adds, “Deciding to obtain the CE Mark based on a claim for two-field accuracy was ambitious but crucial, as this milestone allows Omixon to significantly enhance its reputation as the global leader in NGS-based HLA genotyping”.

During the process of securing the CE Mark approval of the EU Notified Body, Omixon performed a Performance Evaluation Study (PES), to demonstrate accuracy, reproducibility, repeatability and other other key performance characteristics. The results of the PES demonstrated Sensitivity at 97.78% and two-field Genotyping Accuracy at 99.86%.“The results of our PES were fantastic on all of the key metrics”, says Dr. Peter Meintjes, Chief Commercial Officer at Omixon. “European regulatory clearance for Holotype HLA is a significant validation of our unique method for HLA genotyping by NGS and these results clearly demonstrate the superiority of our approach”.

Among the early adopters of Holotype HLA, Dr. Brendan Clarke at Leeds St. James University Hospital notes “the gaining of the CE mark for the Omixon Holotype kit is welcome news and a significant step towards enabling our confident use of the method in the clinical setting of our clinical transplant program”. Additionally, Dr. Juergen Zingsem of Universitätsklinikum Erlangen notes, “it’s wonderful to learn that Omixon has achieved the CE mark now. As we’ve been using Holotype HLA for several months with flawless results, our hospital administration will be as happy as we already are seeing us working with the CE marked Holotype HLA system”.

Omixon ran the most comprehensive Early Access Program of any provider, with reproducibility demonstrated across 26,000 alleles in 24 labs, many of them novices to NGS. Omixon has trained over 70 laboratories with Holotype HLA and more than a dozen labs are in clinical production globally, including Leeds St James University Hospital, the Cleveland Clinic, several labs of the French Blood Service and the Danish Bone Marrow Donor Registry. Additionally, Holotype HLA has been in clinical routine at The Children’s Hospital of Philadelphia (CHOP) since 2013, where over 2500 clinical patient samples have been typed. Five early peer-reviewed manuscripts have already been published, making Holotype HLA the most tested, most trusted, most implemented, most cited and most highly recommended NGS product for HLA genotyping.

Today’s announcement follows the exclusive licensing announcement between Omixon and CHOP in Summer 2014, the global launch of Holotype HLA in Fall 2014 and the worldwide Early Access Program in 2015.