Xenotransplantation Partnerships

Xenotransplantation

The shortage of donor organs remains one of the most significant barriers in organ transplantation, as many patients die before a suitable organ becomes available, while others are not eligible for transplantation based on clinical criteria. Xenotransplantation offers the potential to reduce organ scarcity and expand patient access to transplantation opportunities. At the same time, these advances introduce new challenges in monitoring graft health and infection risk. Emerging molecular diagnostic tools may be used to mitigate these risks.

Karius supports research and development of xenotransplantation across academia and industry by providing microbial cell-free DNA based testing to detect pathogens associated with infectious disease in both porcine organs and recipients. Leveraging our pioneering liquid biopsy technology, Karius created a Xeno Assay to detect over 400 microbes from both porcine and human origin from plasma samples. A summary of the validation is outlined below.

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A modified version of the Karius Test was first applied in the landmark genetically modified pig-to-human heart transplant published in The New England Journal of Medicine¹, with a subsequent case analysis in The Lancet underscoring the infectious disease considerations and viral monitoring challenges associated with clinical xenotransplantation². publications highlight the potential value of incorporating metagenomic sequencing for xenotransplantation.^3,4

Our collaborative research and development is focused on the characterization of the broader nucleic acid compartment in plasma, reporting on RNA pathogens, immunosuppression biomarkers, as well as signs of tissue injury, to offer a comprehensive frameworks for monitoring both infectious and rejection risks in xenotransplant recipients. Through these efforts, we hope to support the safe and effective translation of xenotransplantation into clinical practice.

To learn more about how to partner with Karius in Xenotransplantation and the broader development of porcine-derived products, reach out at partnership@kariusdx.com.

https://kariusdx.com/about-us/partnerships

References

1. Griffith BP, Goerlich CE, Singh AK, et al. Genetically Modified Porcine-to-Human Cardiac Xenotransplantation. N Engl J Med. 2022;387(1):35-44. doi:10.1056/NEJMoa2201422
2. Mohiuddin MM, Singh AK, Scobie L, et al. Graft dysfunction in compassionate use of genetically engineered pig-to-human cardiac xenotransplantation: a case report. Lancet. 2023;402(10399):397-410. doi:10.1016/S0140-6736(23)00775-4
3. Fishman JA, Mueller NJ. Infectious Diseases and Clinical Xenotransplantation. Emerg Infect Dis. 2024;30(7):1311-1318. doi:10.3201/eid3007.240273
4. Fishman JA, Denner J, Scobie L. International Xenotransplantation Association (IXA) Position Paper on Infectious Disease Considerations in Xenotransplantation. Xenotransplantation. 2025;32(2):e70001. doi:10.1111/xen.70001