NEW YORK – Swedish molecular diagnostics firm Devyser Diagnostics said on Monday that it has received In Vitro Diagnostics Regulation (IVDR) approval for two of its kidney and stem cell transplant monitoring tests.
The approved assays are the company's One Lambda Devyser Chimerism test for early detection of stem cell transplant rejection and the One Lambda Devyser Accept cfDNA test for detecting donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients.
Earlier this year, Devyser signed an agreement to grant Thermo Fisher Scientific exclusive rights to commercialize the two tests in Europe and North America, while retaining rights to offer them to labs in the US through its service laboratory.
"With the European IVDR approvals in place, we are excited to partner with Thermo Fisher, the leading innovator in transplant diagnostics, in order to market and sell these products in Europe," Fredrik Alpsten, CEO of Devyser, said in a statement.
The Stockholm-based company also received IVDR approval for its fetal aneuploidy diagnostics test last year.