Waiv Achieves Dual CE Marking Under IVDR, Propelling AI Precision Testing for Breast and Colorectal Cancer for Clinical Routine

Waiv, formerly Owkin Dx, a company advancing AI precision testing, today announced that two of its AI precision tests, RlapsRisk^® BC for breast cancer prognostic risk profiling and MSIntuit^® CRC for colorectal cancer MSI screening, have each received CE marking under the European In Vitro Diagnostic Regulation (IVDR), authorising clinical deployment across EU member states.

Improving Patient Outcomes Through AI-Driven Precision Testing

RlapsRisk BC predicts breast cancer relapse risk directly from standard histopathology slides, and has the potential to deliver genomic-level risk profiling insights to any pathology lab, without extensive further testing. By identifying high-risk patients earlier, it enables more informed, personalized treatment decisions, helping clinicians target aggressive therapies where needed while sparing lower-risk patients from unnecessary treatment.

MSIntuit CRC applies an AI-enabled precision approach to colorectal cancer by offering rapid, scalable Microsatellite Instability (MSI) screening from H&E slides. By integrating into routine testing workflows, MSIntuit CRC rapidly identifies and rules out non-MSI patients, with the aim of streamlining the testing process for the entire patient population with improved turnaround times and optimized resource use. MSI status is a critical biomarker for identifying patients likely to benefit from immunotherapy, and faster detection can accelerate access to more targeted treatments.

A Major Milestone Under Europe’s Most Rigorous Diagnostic Regulation

Meriem Sefta, CEO and Co-Founder, Waiv.

“Securing CE-IVD marking under IVDR is a defining moment for Waiv. This certification reflects not only the scientific and clinical rigor behind our models, but also dedicated work to translate AI innovation into products that can meaningfully impact patient care. We are delivering clinically validated AI precision tests into everyday oncology practice, ready to support the drug development and companion diagnostic partnerships ahead of us. This is a global ambition.”

IVDR certification represents a significant shift from previous regulatory standards, requiring extensive clinical evidence, robust performance validation, and continuous post-market oversight. For Waiv, this milestone reflects significant research, model development, and clinical validation using large-scale multimodal datasets, setting a new benchmark for analytical validity, clinical performance, and real-world reliability.

These approvals strengthen Waiv's position as a trusted partner for laboratories, healthcare providers, and pharmaceutical companies seeking validated AI diagnostics for clinical use and research. Laboratories can access Waiv’s tests through Destra^®, an interoperable digital pathology platform, or by integrating them into existing workflows via compatible IMS and viewer systems such as Proscia, Roche Diagnostics, Sectra, and Tribun Health. Destra offers flexible access to Waiv's precision tests for routine diagnostics and research, including MSIntuit CRC and RlapsRisk BC.