World’s First CE-Certification for Whole-Genome Cancer Dx Software

IVDR certification for the Hartwig Medical Foundation’s OncoAct software covers a workflow that spans raw sequencing to treatment and clinical trial linkage.

Netherlands-based Hartwig Medical Foundation has received CE certification under the European In Vitro Diagnostic Regulation (IVDR) for OncoAct, its whole-genome sequencing.

OncoAct covers the full diagnostic workflow, from raw whole-genome sequencing data to clinical reporting and therapy guidance. Hartwig says it is the first software to receive IVDR CE certification for whole-genome cancer diagnostics in solid tumors.

Announced July 2, “this certification confirms that […] OncoAct, meets the highest European standards for quality, safety and performance. It is an important recognition of the work we have done together with our clinical partners and, ultimately, a step forward for hospitals and patients who can benefit from more comprehensive cancer diagnostics,” Robert Jan Lamers, managing director of Hartwig Medical Foundation, said in a statement.

OncoAct’s analysis capabilities include genome-wide detection and reporting of somatic and germline variants, complex biomarkers including microsatellite instability and homologous recombination deficiency, high-resolution HLA typing, pharmacogenomics, virus detection, and tissue-of-origin prediction. Findings are automatically linked to standard-of-care treatments and relevant clinical trials.

Hartwig said the certification is intended to support broader hospital adoption of WGS-based molecular diagnostics.