Spotlight Medical has achieved a significant regulatory milestone with the CE marking of its AI-driven breast cancer test, myStage Dx, under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR).
This approval marks a crucial step in the company's strategy to expand its market presence in Europe, allowing myStage Dx to be implemented in oncology centers and pathology labs. The test aims to enhance risk stratification for patients with ER+/HER2− early breast cancer, addressing the limitations of traditional methods that rely on broad clinical criteria.
myStage Dx utilizes AI to analyze digitized images of cancer samples alongside available clinical data, providing a binary classification of patients as either Low Risk or Not Low Risk. Clinical validation shows that 95.4% of patients deemed Low Risk remained free of distant recurrence after nine years, indicating the test's potential to improve treatment decisions and patient outcomes.
Sylvain Berlemont, CEO of Spotlight Medical, emphasized the importance of this regulatory approval for integrating myStage Dx into everyday clinical practice. The comprehensive evaluation process included assessments of scientific validity, analytical performance, and risk management, ensuring the test's readiness for deployment in European healthcare systems. This advancement not only strengthens clinical adoption prospects but also positions Spotlight Medical at the forefront of precision oncology.