Omixon to Launch HoloGRAFT ONE, A Research-Use-Only Donor-derived Cell-free DNA Kit and Software for Post-transplant Monitoring

 Press Release
June 1, 2024
Boston, Budapest

Omixon to Launch HoloGRAFT ONE, a Research-Use-Only Donor-derived Cell-free DNA Kit and Software for Post-transplant Monitoring.

Boston, Budapest, June 1, 2024 – Omixon, announced the launching of HoloGRAFT ONE, its research-use-only transplant monitoring kit of donor-derived cell-free DNA based on proprietary genetic markers to distinguish donors from patients and using digital PCR.

HoloGRAFT is an innovative test intended for research applications to measure the absolute and relative quantity of donor-derived cell-free DNA in transplant recipients based on genetic segments present in the donor but absent in the patient, called copy-number variants. Several studies are ongoing to validate the clinical performance of the HoloGRAFT assay. Most recently Karin Boer presented results on 182 monitoring samples from kidney transplant recipients at the European Federation of Immunogenetics meeting in Geneva.

HoloGRAFT ONE is a new product formulation that significantly improves the ease-of-use of the product. In the case of digital PCR transplant monitoring tests, the user is required to select a subset of reagents that represent donor-informative genetic markers. This requires re-thawing and refreezing the corresponding reagents, and such subsetting is subject to human error. Omixon introduces HoloGRAFT ONE as single-use, dry reagents in a strip-of-12-tube format, which enables laboratories to use one strip to generate one report eliminating the need for selecting, thawing, refreezing patient-specific subsets of reagents.

“HoloGRAFT has tremendous benefits compared to alternative methods, states Attila Bérces, founder, and CEO at Omixon, as this is the only test with direct, absolute quantification of donor-specific genetic markers in the cell-free DNA derived from the transplant recipient’s plasma. This new formulation of the test will allow laboratories to experience the technical benefits of HoloGRAFT in an easy-to-use manner.”

“HoloGRAFT’s analytical workflow is much quicker, has higher throughput, and is less expensive than NGS-based methods, states Doug Bost, VP Post-transplant monitoring at Omixon. “You can go from sample to answer in less than three hours, for a fraction of the cost of sequencing tests; and this finally addresses the unmet need of dd-cfDNA tests which can truly be used in routine, frequent monitoring.”

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, the Netherlands and Brazil 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 company to successfully introduce NGS-based HLA typing kit and software in 2014 by bringing Holotype HLA™, an NGS based HLA genotyping product, and HLA Twin™ software to market.

Omixon Twin delivers the most accurate high-resolution HLA genotyping and is used in more than 60+ 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 the first donor-derived cell-free DNA kit HoloGRAFT ONE™ for laboratories with donor-informative genetic markers with primer and probe sequences that are absent in the patient genotype by design.

Inquiries: holograft@omixon.com