New CE-Certified Software Advances Whole-Genome Cancer Testing

European hospitals are increasingly using comprehensive tumor genomics to guide therapy, but routine whole genome sequencing (WGS) requires validated, regulation-compliant workflows. A newly CE-certified software solution now integrates end-to-end WGS analysis and reporting for solid tumors in a single workflow, supporting clinically actionable results and therapy guidance.

OncoAct from Hartwig Medical Foundation (Amsterdam, Netherlands) has received CE certification under the European In Vitro Diagnostic Regulation (IVDR) as a WGS-based software solution for solid tumor cancer diagnostics. Positioned as the world’s first CE-certified IVDR solution for complete whole-genome cancer diagnostics in solid tumors, OncoAct supports the full diagnostic workflow, from raw WGS data to clinically actionable reporting and therapy guidance, within one integrated CE-certified environment. The designation applies to solid tumor use and spans the complete path from sequencing through report generation.

The software enables genome‑wide detection and reporting of all clinically relevant somatic and germline variants, as well as complex biomarkers such as microsatellite instability (MSI) and homologous recombination deficiency (HRD). It also provides high‑resolution human leukocyte antigen (HLA) typing, pharmacogenomics, viral detection, and tissue‑of‑origin prediction. All capabilities are delivered within a single environment that links findings to downstream clinical decision support.

Assessment of OncoAct was conducted by independent clinical and software experts from DEKRA. The certification confirms that the complete analysis and reporting workflow complies with European IVDR requirements for safety, performance, and reliability. The recognition follows years of scientific innovation, rigorous validation, and collaboration with clinical partners.

The CE certification is intended to support hospitals in future‑proof implementation of WGS and the broader adoption of molecular diagnostics for patients with cancer. Because the analysis and reporting workflow has been externally validated, laboratories can reduce local validation efforts and more readily meet IVDR compliance. This alignment is designed to ease operationalization of comprehensive, genome‑wide testing in routine care.

“This certification confirms that our software solution, 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,” said Robert Jan Lamers, Managing Director of Hartwig Medical Foundation.

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Hartwig Medical Foundation