Devyser’s NGS products for monitoring of kidney and stem cell transplanted patients receive IVDR approvals
Devyser’s novel test for detecting donor-derived cell-free DNA in blood samples from kidney-transplant patients and its product for screening and follow-up of stem cell transplanted patients fulfill IVDR requirements in Europe. These tests are the first post-transplant monitoring NGS products to be approved under the new, more comprehensive regulation that came into force in May 2022 and confirm Devyser’s two NGS products meet the established safety, efficacy, and quality requirements.Thermo Fisher Scientific, Devyser’s commercialization partner for these products, can now market and sell