Median Technologies has announced that the REALITY study of its AI/machine learning (ML) powered software as a medical device (SaMD) for lung cancer screening (LCS), eyonis LCS, has met the primary and all secondary endpoints.
This is the first of two pivotal trials required for marketing authorisations in Europe and the US.
The eyonis LCS SaMD is designed to enhance the detection and diagnostic accuracy of low-dose computed tomography (LDCT), the global standard of care for lung cancer screening.
It utilises AI and ML to analyse LDCT imaging data for early-stage cancer diagnosis.
The REALITY study's definitive results indicate that the eyonis LCS can detect and characterise cancerous nodules accurately, achieving an area under the curve (AUC) value of 0.904 at a patient level, surpassing the primary endpoint target of an AUC of 0.8.
Notably, 80% of the cancers in the REALITY cohort were early-stage, difficult-to-diagnose Stage I cancers. The cohort included a high number of small non-spiculated cancers and large spiculated benign nodules, which are typically challenging for radiologists.
Initiated in July 2023, the REALITY trial involved 1,147 subjects from five cancer centres and hospitals in the US and Europe, as well as two clinical data providers.
It assessed the standalone performance of the device in distinguishing cancerous and non-cancerous patients and to detect and characterise suspicious versus malignant nodules.
The primary endpoint was determined in consultation with US regulatory authorities.
The RELIVE study, a Multi-Reader Multi-Case (MRMC) trial, will provide clinical validation for the eyonis LCS, complementing the analytical validation from REALITY.
With patient recruitment and data collection already completed, RELIVE is expected to conclude soon, with results anticipated in the first quarter (Q1) of 2025 and regulatory submissions in the first half of 2025.
Median plans for regulatory filings for the US Food and Drug Administration (FDA) 510(k) premarket clearance and CE marking in the first half of 2025.
Median Technologies CEO Fredrik Brag said: “These data met our ambition for improving the performance of LDCT with the eyonis LCS.
“Now, we are even more excited to report the upcoming RELIVE pivotal data and file for marketing authorisations in H1 2025. We believe that broad implementation of LDCT with eyonis LCS has the potential to vastly improve early detection and lead to far more cures, dramatically reducing lung cancer mortality.”
