Earlier detection of graft rejection

STOCKHOLM—Swedish molecular diagnostics company Devyser Diagnostics AB shared news of the receipt of a grant through the Eurostars-2 program worth EUR 750,000. Devyser intends to use the funding to further develop its next-generation sequencing (NGS)-based test for monitoring graft status and early diagnosis of organ rejection in kidney transplant recipients.

“The Eurostar funding is very encouraging and enables us to finalize the development of this unique test approach with the potential to significantly reduce the rejection rate in organ transplants, starting in kidneys. The grant is also a clear validation of our technology and test method,” said Fredrik Alpsten, CEO of Devyser Diagnostics.

The University Hospital of Zurich is Switzerland's largest organ transplantation center, and has performed more than 900 adult kidney transplants since 2008. The hospital collects sequential serum samples post-transplantation, including donor and recipient pre-transplant DNA samples, and has created a biobank of samples from transplant recipients together with the clinical Transplant Immunology Laboratory.

“We are very excited to have entered this joint development project with Devyser. Their products are made ideal for routine diagnostics, being simple, reproducible, and low prone to user-generated errors. By combining Devyser’s specialist competence in developing diagnostic kits for complex DNA testing, with our experience and expertise within transplantation, we will be able to conclude the development and have the test evaluated in the best possible clinical environment,” Jakob Nilsson, director of Transplant Immunology in the Department of Immunology at University Hospital Zürich, commented in a press release.

Devyser is developing its NGS-based test under the ENVISAGE project, a consortium between Devyser and the University Hospital of Zurich. The NGS test detects and quantifies donor-derived cell-free DNA (dd-cfDNA) in plasma for maximum sensitivity and specificity, according to Devyser, and providing clinicians with precise information of graft and patient status. The duration of the project is 36 months, beginning January 2021.

More than 139,000 organ transplantations are performed worldwide each year, and rejection is a leading complication, particularly in the case of kidneys—according to Devyser, more than 60 percent of kidney grafts are lost due to the recipient's immune system rejecting the donor organ. The company notes that thus far, graft monitoring by testing dd-cfDNA has not been feasible, but Devyser hopes to use the ENVISAGE project and Eurostars funding to produce a certified in-vitro diagnostics kit—complete with reagents, protocols, and software for data analysis—that is fit for routine use.

“As our assay detects rejection at its onset, the earliest possible medical intervention could be facilitated, increasing the likelihood that the graft is accepted by the patient. At a higher level, our NGS-based test will allow routine testing at a low cost for the healthcare system, and thereby support higher utilization of donor grafts,” explained Ulf Klangby, COO of Devyser.

Initially, the test will be optimized and validated specifically for kidney transplants, but boosting its sensitivity and specificity up to 99.99 percent “will make the test universal for detection and quantification of chimerism in recipients of any type of solid transplant, with any kind of grafts,” Devyser stated in a press release.