# Spotlight Medical's myStage Dx Test Reclassifies 23.5% of High-Risk Breast Cancer Patients

> Spotlight Medical's myStage Dx test identified 23.5% of clinically high-risk breast cancer patients as low risk.

- Published: 2026-10-22T10:46:15+00:00
- Section: Research & Clinical Trials
- Author: News Desk
- URL: https://newsforagent.com/news/2026-10-22/spotlight-medical-mystage-dx-evaluation
- Source: [Business Wire](https://www.businesswire.com/news/home/20261022574100/en/)

## Key takeaways

- An independent blinded evaluation of 620 PANTHER trial patients found myStage Dx classified 23.5% of clinically high-risk patients as Low Risk.
- Ten-year survival free from breast cancer recurrence was 96.1% in the Low Risk group versus 76.6% in the Not Low Risk group.
- Spotlight Medical received IVDR CE marking for myStage Dx in June 2026, enabling commercial launch across European oncology centers.

[Spotlight Medical](https://akta.pro/company-profiles/0000wam/spotlight-medical) said an independent, blinded evaluation of its myStage Dx test identified 23.5% of clinically high-risk breast cancer patients as Low Risk, with 96.1% of that group alive and free from recurrence at ten years. The Paris-based oncology diagnostics company announced the results on October 22, 2026, according to [Business Wire](https://www.businesswire.com/news/home/20261022574100/en/).

## How the Karolinska Institutet Evaluation Worked

The study used data from 620 patients enrolled in PANTHER, an international randomized phase III trial comparing dose-dense with standard chemotherapy. Researchers at [Karolinska Institutet](https://akta.pro/company-profiles/0003kt4/karolinska-institutet) generated myStage Dx predictions blinded to clinical outcomes, then linked those predictions to patient outcomes and assessed prognostic performance under a prespecified protocol and statistical analysis plan.

Within the clinically high-risk population, the test separated two groups with markedly different long-term outcomes. The Low Risk group comprised 23.5% of patients. At ten years, the estimated proportion alive and free from breast cancer recurrence was 96.1% in the Low Risk group, compared with 76.6% in the Not Low Risk group. The difference remained statistically significant after adjustment for standard clinicopathological prognostic factors.

Dr. Marvin Lerousseau, co-founder and CSO of Spotlight Medical, said: "Confidence in a clinical test has to be earned through independent scrutiny. We chose a blinded evaluation of myStage Dx by an independent research team, accepting that the results were outside our control."

## Spotlight Medical's Funding and Regulatory Record

Spotlight Medical is a Paris-based AI diagnostics company founded in 2024, according to akta.pro [company records](https://akta.pro/company-data). The company closed a €6.2 million seed funding round in July 2024 led by Kurma Partners with participation from Heal Capital and support from Bpifrance. Its total funding stands at $6.8 million, and it is pre-revenue with an estimated valuation of $10 million to $50 million.

In June 2026, Spotlight Medical obtained IVDR CE marking for myStage Dx as a Class C medical device, enabling commercial launch across European oncology centers, pathology laboratories, and digital pathology partners. A 2025 peer-reviewed clinical validation in the Journal of Clinical Oncology showed that 95.4% of Low Risk patients remained free of distant recurrence at nine years and 19.4% of clinically high-risk patients were reclassified as Low Risk.

## Earlier Milestones for myStage Dx

Spotlight Medical received CE marking under the European Union In Vitro Diagnostic Medical Devices Regulation for myStage Dx in June 2026, according to Business Wire Blog. The test is designed for ER+/HER2− early breast cancer patients.

## What Comes Next for Spotlight Medical

The company said the findings build on earlier evidence from the CANTO and UNIRAD trial cohorts, published in the Journal of Clinical Oncology in 2025. The IVDR CE marking enables commercialization with oncology centers, pathology laboratories, and digital pathology partners across Europe.

## Companies in this story

- [Spotlight Medical company profile](https://akta.pro/company-profiles/0000wam/spotlight-medical) · website: https://spotlightmedical.com
- [Karolinska Institutet company profile](https://akta.pro/company-profiles/0003kt4/karolinska-institutet) · website: http://www.ki.se

---
News for Agent · https://newsforagent.com/llms.txt