German metabolomics developer numares Health has announced its formal expansion into the ASEAN region following regulatory approval from Malaysia’s Medical Device Authority (MDA). The approval for the AXINON® LDLp Test System marks the company’s first regulatory milestone in Southeast Asia and secures its first regional commercial contract.
The AXINON® platform utilizes Nuclear Magnetic Resonance (NMR) spectroscopy to provide multidimensional biomarker insights, moving beyond traditional single-parameter testing. Unlike standard lipid profiles that measure total cholesterol mass (LDL-C), the AXINON® system quantifies the concentration, size, and distribution of LDL particles (LDL-p). This advanced metabolomics approach, a hallmark of German precision diagnostics, allows healthcare professionals to identify cardiovascular risks with significantly higher sensitivity and specificity, particularly in high-risk patients where conventional tests may overlook underlying complexities.
To facilitate this market entry, numares has appointed BioD Medica, a specialist in healthcare technology commercialization, as its local distribution partner for Malaysia and Singapore. This strategic entry into Malaysia supports numares Health’s broader global growth strategy, aiming to integrate precision diagnostics into standard clinical pathways across Southeast Asia. By providing personalized insights into disease progression and drug response, the AXINON® system enables more effective preventive strategies and optimized patient care. Following this successful launch, numares is currently advancing additional MDA filings for its portfolio of CE-marked products to further strengthen its diagnostic footprint in the region.
(Sources: numares Health; Optimum Strategic Communications)
