Danish medical diagnostic company Atonomics has announced the CE marking of its first commercial product, a Lipids test panel on its Trace platform.
Trace, a personal biomarker device, is a disruptive self-testing platform for diagnostics. The Lipids panel determines total cholesterol, HDL (high density lipids), LDL (low density lipids) and triglycerides levels from a finger prick of blood with quantitative lab standard results provided within minutes, according to the company. The simple cartridge test can be used to monitor the effectiveness of diet, lifestyle changes and medication to lower cholesterol. The device will be linked to an app for read-out and tracking.
“We are delighted to launch our first product after having demonstrated that we can achieve central lab accuracy in a small and user friendly format ideally suited for point-of-care applications. While the initial CE mark is for in-vitro diagnostics (IVD) professional use, a CE mark for self-testing is targeted for later this year, which will enable us to market Trace directly to consumers for home use,” said Thomas Warthoe, CEO.