Skip to main content
Premium Trial:

Request an Annual Quote

Devyser Receives IVDR Certification for Kidney, Stem Cell Transplant Monitoring NGS Tests

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.

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.