AI Cancer Test Clears EU Hurdle, Aiming to Refine Breast Cancer Care

PARIS, France – June 23, 2026 – In a move that signals a significant step forward for AI in clinical practice, Paris-based Spotlight Medical has secured European regulatory approval for myStage Dx, an innovative prognostic test for early-stage breast cancer. The certification, granted under the European Union’s rigorous In Vitro Diagnostic Medical Devices Regulation (IVDR), clears the path for the company to commercialize its software-based tool across Europe. The technology aims to provide oncologists with a more precise crystal ball, helping them identify which patients with a common form of breast cancer are at low risk of recurrence and may safely forego aggressive treatments.

At its core, myStage Dx is a software-only medical device that uses artificial intelligence to analyze a digitized image of a standard, H&E-stained tissue slide from a patient's primary tumor. By combining this visual data with existing clinical information, the algorithm generates a clear, binary classification: “Low Risk” or “Not Low Risk” of the cancer returning within nine years. This decision-support tool is designed specifically for patients with the most prevalent subtype of breast cancer—estrogen receptor-positive, HER2-negative (ER+/HER2−)—a group where the decision to intensify treatment with chemotherapy is often a complex balancing act.

A New Standard for Safety and Performance

The CE marking is more than a simple green light; it represents the successful navigation of one of the world's most demanding regulatory landscapes for medical devices. The IVDR, which fully replaced the previous directive in 2022, dramatically raised the bar for safety, clinical evidence, and post-market surveillance. For a device like myStage Dx, classified as a higher-risk “Class C” device, this meant undergoing intense scrutiny from an independent Notified Body.

Under the old rules, most diagnostic tests could be self-certified by the manufacturer. The IVDR, however, mandates that roughly 80-90% of all in-vitro diagnostics, including sophisticated software like this, require third-party validation. Spotlight Medical had to furnish a complete performance evaluation package, demonstrating scientific validity, analytical performance, and robust clinical evidence. The process also demanded comprehensive documentation on everything from software validation and cybersecurity to risk management and the AI's lifecycle. This arduous process ensures that the tool is not just innovative but also safe, reliable, and effective, providing a strong foundation for clinical adoption.

Furthermore, the IVDR mandates a proactive post-market surveillance system. Spotlight Medical will be required to continuously collect data on the test's real-world performance and submit annual safety updates. This framework is designed to build trust and ensure that the device's benefits continue to outweigh any risks long after its initial launch.

The High Stakes of ‘Not Low Risk’

For physicians treating ER+/HER2− early breast cancer, the central dilemma is identifying which patients truly need chemotherapy. While many are classified as having a high clinical risk based on traditional factors like tumor size and node involvement, this is an imprecise science. A significant portion of these patients may not benefit from chemotherapy but will still endure its debilitating side effects, impacting long-term health and quality of life. The challenge is to de-escalate treatment for those who can be safely spared, a concept at the heart of precision medicine.

This is where myStage Dx aims to make its mark. The clinical evidence underpinning its approval, published in the esteemed Journal of Clinical Oncology, is compelling. In validation studies involving two large, prospective patient cohorts (CANTO and UNIRAD), the AI-powered test identified nearly one in five patients (19.4%) previously deemed clinically high-risk as actually being “Low Risk.”

Crucially, this re-classification was backed by outstanding outcomes. At the nine-year follow-up, 95.4% of the patients classified as Low Risk by myStage Dx remained free of distant recurrence and had not died from breast cancer. This stands in stark contrast to the 76.8% survival rate for the “Not Low Risk” group, validating the algorithm's ability to successfully stratify patients and find the signal of true low risk within the noise of traditional pathology.

AI Enters a Crowded Diagnostic Field

Spotlight Medical is not entering an empty arena. The market for breast cancer prognostic tests has been dominated for years by established genomic assays like Oncotype DX and MammaPrint. These multi-gene expression tests analyze the activity of dozens of genes within a tumor sample to produce a recurrence score, and they have become a standard of care for guiding chemotherapy decisions. They have proven clinical utility, extensive data, and strong inclusion in international treatment guidelines.

However, these genomic tests come with logistical and financial considerations. They often require specialized laboratory processing, can be costly, and may take weeks to return a result. Spotlight Medical’s myStage Dx offers a fundamentally different approach. By leveraging artificial intelligence and digital pathology, it works with the standard, universally available H&E-stained slide that is prepared for every cancer patient. This means no special tissue handling, no shipping samples to a central lab, and the potential for a much faster and more cost-effective workflow that integrates directly into a hospital’s existing digital pathology infrastructure.

“The test was designed for practical integration into routine oncology and pathology workflows, using standard H&E slides and baseline clinicopathological data to provide physicians with a clear prognostic classification,” said Sylvain Berlemont, CEO of Spotlight Medical, in the company’s announcement. “This regulatory achievement gives us a strong foundation to support clinical adoption and to roll out myStage Dx across European hospitals.”

This approach, which transforms a simple stained slide into a source of deep prognostic data, represents a paradigm shift. It democratizes access to advanced prognostics by using the very materials and data points already present in the standard diagnostic pathway. By building its intelligence into software that works with existing hardware, Spotlight Medical is positioning myStage Dx not as a replacement for the pathologist, but as a powerful new tool in their digital arsenal. As hospitals across Europe continue to digitize their pathology labs, the demand for such integrated, AI-driven solutions is expected to grow, marking a new chapter in the ongoing quest for more precise and personalized cancer care.