SOPHIA ANTIPOLIS, France - Median Technologies has announced a significant advancement in its lung cancer screening technology, eyonis™ LCS, following an independent verification study. The software, which aids in the detection and characterization of malignant lung nodules, has demonstrated improved performance, crucial for regulatory approval processes.
The proprietary algorithm, developed in the latter half of 2023, achieved an Area Under the Curve (AUC) of 0.93 in a cohort of 300 patients. This result significantly exceeds the primary endpoint of AUC 0.80 set for the pivotal standalone study required for regulatory clearances. The previous version, tested in 2022 and early 2023, had reported an AUC of 0.91.
These findings are pivotal for the upcoming analytical and clinical validation studies, named REALITY and RELIVE, respectively. These studies are necessary steps toward obtaining 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE marking in Europe. Median Technologies aims for market authorization in the United States by the first quarter of 2025 and in Europe by mid-2025.
The enhanced performance of eyonis™ LCS is expected to have a significant medico-economic impact, potentially improving early diagnosis rates for lung cancer, which is the leading cause of cancer death globally. The technology aligns with the European Union's recommendations for national lung screening programs as part of "Europe's Beating Cancer" plan.
Fredrik Brag, CEO and founder of Median Technologies, highlighted the strategic importance of the new algorithm, which is set to provide a competitive edge in early lung cancer diagnosis. He also referenced the existing U.S. screening program covering 14.5 million Americans and the temporary reimbursement code of $650 per patient, indicating a substantial market for eyonis™ LCS.
This announcement is based on a press release statement from Median Technologies.
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