AI Precision Tests Deliver Cancer Risk Insights from Routine H&E Slides

Reliable prognostic profiling and biomarker screening are essential to guide oncology treatment decisions, while laboratories must balance speed and resource constraints. Earlier identification of high‑risk breast cancer and rapid assessment of microsatellite instability (MSI) in colorectal cancer can support personalized care and streamline workflows. A newly authorized pair of artificial intelligence tests now enables clinical use across the European Union after receiving CE marking under the European IVDR, allowing routine deployment.

Waiv (formerly Owkin Dx) has obtained CE‑IVDR marking for two AI precision tests: RlapsRisk BC for breast cancer prognostic risk profiling and MSIntuit CRC for colorectal cancer MSI screening. The authorization allows clinical deployment across European Union member states. Both tests are available to laboratories via Destra, an interoperable digital pathology platform, or through integration into existing workflows.

RlapsRisk BC predicts breast cancer relapse risk directly from standard histopathology slides. The approach has the potential to deliver genomic‑level risk‑profiling insights without extensive further testing. By identifying high‑risk patients earlier, it supports more informed, personalized treatment decisions and may help target aggressive therapies where needed while sparing lower‑risk patients from unnecessary treatment.

MSIntuit CRC applies an AI‑enabled precision approach to offer rapid, scalable MSI screening from H&E slides. By integrating into routine testing workflows, it rapidly identifies and rules out non‑MSI patients, aiming to streamline the process for the entire patient population. The design seeks to improve turnaround times and optimize resource use, addressing a biomarker that is critical for identifying patients likely to benefit from immunotherapy and helping accelerate access to more targeted treatments.

Both tests achieved CE marking under the European In Vitro Diagnostic Regulation (IVDR). IVDR certification requires extensive clinical evidence, robust performance validation, and continuous post‑market oversight. Laboratories can access the tests through Destra, which is compatible with leading IMS and viewer systems including Proscia, Roche Diagnostics, Sectra, and Tribun Health.

“Securing CE-IVD marking under IVDR is a defining moment for Waiv,” said Meriem Sefta, CEO and Co‑Founder, 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.”

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