Devyser advances U.S. clinical strategy with first patient enrolled in Devyser Accept cfDNA study
Devyser today announced the enrollment of the first patient in its Devyser Accept cfDNA clinical trial, a key milestone in the company’s efforts to bring a targeted next-generation sequencing solution for kidney transplant monitoring to the U.S. diagnostic market.
The multicenter, prospective observational study will enroll up to 400 kidney transplant recipients across six of the leading U.S. transplant centers. The objective is to generate clinical evidence supporting the validation of the Accept cfDNA NGS assay by comparing cfDNA-based rejection signals with traditional kidney biopsy results.
Accept cfDNA is a targeted next-generation sequencing assay designed to measure donor-derived and recipient-derived circulating cell-free DNA. By leveraging genetic differences, specifically short insertions and deletions (indels), the assay aims to offer a sensitive, minimally invasive indicator of rejection risk, potentially reducing the need for biopsy-based assessments.
“Initiating enrollment in this study marks an important step toward our FDA submission pathway,” said Jan Wahlström, CEO, Devyser. “Accept cfDNA has the potential to transform how clinicians monitor transplant health, making high-quality post-transplant surveillance more accessible and less invasive.”
The study, registered under NCT07006831, is titled “A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population” and can be found on ClinicalTrials.gov.