Lung Cancer Screening Technology Demonstrates High Sensitivity and Specificity
Median Technologies announced outstanding performance of its iBiopsy LCS AI/ML tech-based end-to-end CADe/CADx Software as Medical Device, reached 94.7% sensitivity at 93.3% specificity, based on a cohort of 1,760 patients. The technology is intended to enable early detection and characterization of lung cancer nodules and improve clinical management of patients. The company reported it has started the regulatory engagement and the design of the pivotal clinical studies for iBiopsy LCS CADe/CADx SaMD, and aims to obtain a US FDA approval and market authorization by the end of 2023.
Median’s iBiopsy LCS SaMD offers a unique end-to-end detection/diagnosis approach (CADe/CADx) based on AI/ML technologies. Median aims at drastically improving the ability to detect and characterize lung cancers at their earliest stages, enabling a better patient care while avoiding unnecessary medical tests and procedures, and reducing healthcare costs. No product is currently approved for both lung cancer detection and diagnosis in the US or Europe. With this breakthrough innovation, Median’s iBiopsy LCS SaMD brings a unique AI-powered solution for clinicians to fight lung cancer, the deadliest cancer worldwide.
The study was based on a cohort of 1,760 patients from the National Lung Screening Trial (NLST) consisting of a total of 16,789 lung nodules. The training set was composed of a subset of 1,289 patients with 12,108 nodules and the test set represented 471 patients with a total of 4,681 nodules.
The performance of iBiopsy LCS CADe/CADx SaMD to detect and characterize lung cancer nodules achieves an AUC of 0.976 and an outstanding sensitivity of 94.7% for a specificity of 93.3%.
“We are thrilled to announce our performance. These results pave the way for a disruptive approach in lung cancer screening management,” Fredrik Brag, CEO and founder of Median Technologies said. “We have already initiated our interactions with the FDA with the recent 513(g) submission, which will allow us to determine the best FDA regulatory pathway for our iBiopsy LCS SaMD. Our next step will be to integrate the FDA’s comments in the protocols of the pivotal clinical studies that we will launch in the second half of 2022. In parallel, we are reviewing our regulatory pathway to the CE-Mark in Europe,” Brag added.