Freenome Ltd

Freenome Ltd manufactures diagnostic devices focused on early cancer detection. Specifically, the company produces the EarlyCDT Lung Test Kit, a blood-based test designed to identify potential lung cancer in patients with suspicious symptoms or risk factors. This device leverages biomarkers to enable earlier diagnosis, which can improve treatment outcomes.

Freenome Ltd is based in the United Kingdom. As a UK-based manufacturer, its devices are subject to EU regulatory requirements if marketed within the European Economic Area. The EarlyCDT Lung Test Kit, for example, is classified as a Class C device under EU regulations, meaning it undergoes rigorous evaluation for safety and performance before being registered in the EUDAMED database.

Freenome Ltd’s devices, including the EarlyCDT Lung Test Kit, are listed in the EUDAMED database. This registry is important because it provides transparency on the devices available in the European market, their classification (e.g., Class C), and their regulatory status. Listing in EUDAMED ensures compliance with EU medical device regulations and helps healthcare professionals and authorities verify the device’s authorised status.

Freenome Ltd’s EarlyCDT Lung Test Kit is classified as a Class C medical device under EU regulations. This classification is determined by factors like the device’s risk level, intended use, and potential impact on patient health. Class C devices are considered high-risk and require comprehensive clinical evidence to demonstrate safety and performance before authorisation, ensuring they meet stringent standards for use in diagnosing serious conditions like cancer.