Finnish biomedical startup Nightingale Health has announced today CE Marking for its blood biomarker analysis platform. The CE mark enables the clinical use of the analysis service and the analysed measures of creatinine and glucose in the EU region.
Nightingale’s goal is to bring dozens of biomarkers included in the analysis platform gradually available for clinical use within the next year. The obtained CE mark is a remarkable step towards the company’s aim, enabling better prediction and targeted care for chronic diseases.
‘The CE mark verifies the performance, reliability, and repeatability of our blood analysis technology for clinical use according to our quality management system. We expect a rapid entry to the clinical market across Europe’, says Mr. Teemu Suna, Nightingale Health’s CEO, and co-founder. ‘We believe that our technology takes us one step closer to better prevention of chronic diseases. Therefore, we see this as a notable milestone, not only for our company but also for preventive medicine.’
Nightingale Health's blood biomarker analysis platform is based on NMR (Nuclear Magnetic Resonance) spectroscopy. It captures over 228 metabolic biomarkers from a single blood sample, transforming the possibility to understand molecular mechanisms and treatment effects of chronic diseases, such as cardiovascular disease, diabetes, and other metabolic diseases. To date, Nightingale Health’s blood biomarker analysis platform has been used by world leading medical universities and institutions, and nearly half a million blood samples have been analysed with the technology. Nightingale Health’s quality management system has previously been certified according to EN ISO 13485 standard.
Diabetes and cardiovascular diseases are one of the world’s biggest health problems. The global burden of diabetes has been evaluated at $ 1.31 trillion, equivalent of 0,6 per cent of the world’s GDP.
Nightingale Health’s biomarker analysis platform provides quantification of 228 metabolic measures from a single sample with one test. The metabolites are quantified in absolute concentrations (e.g. mmol/l), so they can be applied both in healthcare and in medical research. The method is fully feasible for diagnostic use of individual biomarkers, research of multiple biomarker metabolic pathways, and the risk analytics of comprehensive metabolic diseases. The now obtained CE mark covers the clinical use of creatinine and glucose measures.