- AXINON LDLp Test System receives Medical Device Authority (MDA) in Malaysia
- numares Health appoints BioD Medica for local distribution
- MDA filing for additional CE-marked product is currently in progress
REGENSBURG, Germany, Dec. 17, 2025 /PRNewswire/ -- numares Health ("numares"), the transformative metabolomics company pioneering multidimensional biomarker insights that deliver clinical pathways for optimal patient care, today announces the expansion of its global footprint into the ASEAN region having received regulatory approval in Malaysia and subsequently securing its first contract for the AXINONLDLp Test System ("AXINON") with BioD Medica, who specialise in introducing medical devices and healthcare technology into Malaysia and Singapore.
Florian Voss, Chief Executive Officer at numares Health said: "Malaysia is a known leader in innovation in the ASEAN region and their swift approval and adoption of the AXINON LDLp Test System reflects this cutting-edge reputation. AXINON guides treatment pathways and preventive strategies by enabling the earlier detection of complex conditions from the analyses of single biomarkers and complex constellations, delivering multidimensional, personalized disease and drug response insights, dramatically improving sensitivity and specificity. This delivers meaningful clinical utility to healthcare professionals, and we look forward to bringing these benefits to patients in Malaysia and the wider region."
This is the first regulatory approval in the ASEAN region for the AXINONLDLp Test System. Concurrently, numares has secured its first contract with BioD Medica, who specialise in introducing medical devices and healthcare technology into Malaysia and Singapore, providing healthcare professionals with accessible and innovative diagnostic devices to transform patient outcomes.
Cardiovascular diseases (CVDs) are the leading cause of death globally according to the World Health Organization. The most important biomarkers for determining CVD risk are lipids, including total cholesterol, triglycerides, LDL and HDL cholesterol. Studies show standard lipid profile tests do not capture all available information, whereas the AXINON LDLp Test System measures the concentration, size and distribution of lipoprotein particles (LDL-p) - the particles that carry cholesterol - to provide a more accurate result, especially for people with comorbidities who are at higher risk for CVDs.
About numares Health
numares Health is a pioneering metabolomics platform delivering multidimensional biomarker insights and clinical pathways for optimal patient care. Its highly automated digital conversion of biochemical pathways uses NMR spectra to simultaneously measure hundreds of biomarkers from a single, minimally-processed sample, ensuring precise, consistent, scalable and streamlined workflows across labs, clinical trials/treatment and geographies. With robust standardization, incremental tests can also be rapidly processed, even from historically collected spectra, accelerating the pace of clinical research. These digital biomarkers allow the seamless transition from lab bench to bedside, with no further chemical intervention required, dramatically saving costs, while boosting accuracy and efficiency.
About the AXINON System
numares Health's AXINONSystem produces analyses of single biomarkers and complex constellations, delivering multidimensional, personalized disease and drug response insights, dramatically improving sensitivity and specificity. This supports prognostic clinical utility, guiding treatment pathways and preventive strategies and enabling the earlier detection of complex conditions. Historic digital sample data can also be re-processed for new metabolite analyses to improve design, stratification and monitoring of clinical trials in drug development.
numares Health's aim is to revolutionize R&D and treatment in the way that genomic analyses have changed cancer treatment but with far greater scope across intersecting causes of disease. It wants to change medicine from diagnosis/management of symptoms to accurately finding and treating underlying causes of disease.
View original content:https://www.prnewswire.co.uk/news-releases/numares-health-enters-asean-region-with-regulatory-approval-in-malaysia-and-first-contract-win-for-axinon-ldlp-test-system-302643869.html
