Press Release
June 11, 2024
Budapest, Hungary
Omixon Receives IVDR approval for NanoTYPE™ CE IVDR
Pioneering Transplant Diagnostic with the First CE IVDR Kit based on Oxford Nanopore Technologies
Omixon has received In Vitro Diagnostic Regulation (IVDR) approval of NanoTYPE™, an innovative high resolution multiplex 11 loci human leukocyte antigen (HLA) amplification kit. These assays are among the first HLA genotyping kits to be approved under the new, more comprehensive regulation that came into force in May 2022. It confirms Omixon’s NanoTYPE meets the established safety, efficacy, and quality requirements for approval. Compatible with Oxford Nanopore’s MinION™ and GridION™ platforms, NanoTYPE addresses a thriving $200 million market in molecular transplant diagnostics. Outside transplantation HLA genotyping plays an increasing role in immuno-oncology, disease association and as companion diagnostics.
NanoTYPE represents a significant step forward in HLA typing, offering a notable contribution to the field by enabling laboratories to thoroughly characterize histocompatibility antigens at the protein coding level. This technology provides valuable insights for pre-transplantation procedures. Unlike some current Next-Generation Sequencing (NGS) technologies, NanoTYPE features a simplified workflow that doesn’t require significant infrastructure investment. Its quick sample preparation process and capacity to handle smaller sample series help improve laboratory efficiency.
Attila Berces, CEO of Omixon Biocomputing said that “NanoTYPE not only represents the simplest NGS HLA genotyping workflow without large investment, but also the shortest turnaround time and scalability from one to many samples.”
Gregory Werner, Omixon’s VP of Product Innovation, illuminates the transformative potential inherent in the NanoTYPE solution: “Beyond the intrinsic benefits of long-read sequencing and the adaptability introduced by reusable consumables, the portability and affordability of nanopore sequencers redefine access to cutting-edge laboratory solutions. What was once a privilege reserved for well-funded laboratories has now become attainable for emerging and developing countries, opening doors to the establishment of national registries at an economical cost. This significance is further underscored as we advance to validate other sequencing platforms from ONT such as the PromethION 2 Solo and integrated (P2). This evolution allows the simultaneous processing of up to 96 samples on one flow cell, with results reported the next day.”
Dr. Emma Stanton, Senior Vice President for Clinical, Oxford Nanopore Technologies, said: “We are excited to see the approval of the NanoTYPE™ CE IVDR kit, an important innovation in the field of HLA genotyping. This marks an important step forward in transplant diagnostics, showcasing the potential of Oxford Nanopore’s sequencing technology. Our vision to integrate nanopore sequencing into clinical care is rapidly becoming a reality, and this milestone is evidence of that progress. We are excited about the future impact this will have on patient outcomes.”
Having undergone a successful introduction to selected laboratories in January 2021, NanoTYPE has already genotyped over 10,000 samples under Research Use Only (RUO) status in the US. The product’s genotyping performance was rigorously evaluated in a clinical validation study l conducted in 2023, involving four laboratories in Europe and encompassing a total of 400 samples. The clinical performance study, an integral part of the documentation required for CE IVDR certification, demonstrated an impressive 99.6% accuracy.
Omixon Biocomputing is thrilled to bring NanoTYPE CE IVDR to market, marking a transformative milestone in transplant diagnostics.
ABOUT OMIXON
Omixon is a global transplantation diagnostic company with a mission to provide histocompatibility laboratories with innovative technologies to improve transplant outcomes. Omixon is headquartered in Budapest, Hungary, with operations in the United States, Brazil and the Netherlands serving more than 100 laboratories worldwide.
Building on multidisciplinary competences in bioinformatics, software engineering, molecular biology and regulatory science, Omixon transforms molecular biology innovations into state-of-the-art products in transplant diagnostics.
Omixon was the first to successfully introduce a Next-Generation sequencing (NGS) based HLA genotyping kit and software in 2014 by bringing Holotype HLA assay and HLA Twin software to market. HLA Twin is a leading software for high-resolution HLA genotyping and is used in more than 100 laboratories worldwide.
Omixon was the first to release a high resolution HLA genotyping product NanoTYPE HLA with less than 5 hours turnaround time on the Oxford Nanopore sequencing platform complemented by NanoTYPER analysis software.
Omixon is the first to bring to market a donor-derived cell-free DNA kit HoloGRAFT for laboratories with donor-informative genetic markers with primer and probe sequences that are absent in the patient genotype by design.
ABOUT OXFORD NANOPORE TECHNOLOGIES
Oxford Nanopore Technologies’ goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for real-time, high-performance, accessible and scalable analysis of DNA and RNA. The technology is used in more than 120 countries to understand the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses and whole environments. Oxford Nanopore Technologies products are intended for molecular biology applications and are not intended for diagnostic purposes. www.nanoporetech.com
INQUIRIES: marketing@omixon.com
