Original from: Hartwig
We are proud to announce that Hartwig Medical Foundation has received CE certification under the European In Vitro Diagnostic Regulation (IVDR) for Hartwig Medical OncoAct (OncoAct), our software solution for cancer diagnostics based on Whole Genome Sequencing (WGS) in solid tumors.
OncoAct is the world’s first CE-certified solution under IVDR for complete whole-genome cancer diagnostics in solid tumors. It supports the entire diagnostic workflow—from raw whole genome sequencing data to clinically actionable reporting and therapy guidance—within one integrated, CE-certified workflow.
This certification reflects years of scientific innovation, rigorous validation and close collaboration with leading clinical partners. It underlines the quality and robustness of our tools and products required for use in a routine diagnostic setting.
“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,” says Robert Jan Lamers, Managing Director of Hartwig Medical Foundation.
One complete workflow
What sets OncoAct apart is the completeness of the solution. The software covers the full diagnostic workflow, from raw whole genome sequencing data to genome-wide detection and reporting of all clinically relevant somatic and germline variants, complex biomarkers such as MSI and HRD, high-resolution HLA typing, pharmacogenomics, viral detection and tissue-of-origin prediction.
In addition, all findings are automatically linked to standard-of-care treatments and relevant clinical trials, providing clinicians with one integrated workflow from raw data to therapy guidance and supporting better-informed treatment decisions.
The assessment of OncoAct was carried out by independent clinical and software experts from DEKRA. The certification confirms that the complete analysis and reporting workflow complies with the European IVDR requirements for safety, performance and reliability.
Ready for broader implementation
The CE certification supports hospitals in the future-proof implementation of WGS and the broader adoption of molecular diagnostics for patients with cancer. Because the complete analysis and reporting workflow has been externally validated, hospitals can reduce their local validation efforts and more easily comply with the European IVDR requirements.
Source: Hartwig receives CE certification for OncoAct, the first complete IVDR-certified whole-genome cancer diagnostics solution
