NEW YORK – Swedish molecular diagnostics firm Devyser Diagnostics said on Tuesday that it has received a €750,000 ($909,000) grant through the Eurostars-2 program to develop a next-generation sequencing assay for monitoring graft status and early detection of rejection in kidney transplant recipients.
The firm has launched a three-year project called ENVISAGE with the University Hospital of Zurich, the largest organ transplant center in Switzerland, to further develop the test. The goal is to launch an in vitro diagnostic kit, including reagents, protocols, and data analysis software, for routine testing.
Devyser's NGS platform detects and quantifies donor-derived cell-free DNA in plasma, providing information to support long-term graft and patient survival.
"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," Ulf Klangby, chief operating officer of Devyser, said in a statement. "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."
While Devyser will initially optimize and validate the NGS test for kidney transplants, the firm believes that improving the test's sensitivity and specificity will help detect and quantify chimerism in patients with any type of solid transplants.
"[Devyser's] products are made ideal for routine diagnostics, being simple, reproducible, and [not very] prone to user-generated errors," Jakob Nilsson, director of transplant immunology at University Hospital of Zurich, said in a statement. "By combining Devyser's specialist competence in developing diagnostic kits for complex DNA testing with our experience and expertise within translation, we will be able to conclude the development and have the test evaluated in the best possible clinical environments."
Devyser received CE marking for its NGS-based hereditary breast cancer and ovarian cancer assay last July.