YHLO launches first commercial CD146 test for cerebrospinal fluid powered by chemiluminescence technology

YHLO Biotech has obtained medical device registration approval from the Guangdong Medical Products Administration for its independently developed soluble CD146 (sCD146) assay kit (chemiluminescence immunoassay).

As the first company globally to offer a commercially available sCD146 assay for cerebrospinal fluid (CSF), YHLO marks a significant breakthrough in central nervous system (CNS) disease diagnostics. This milestone brings YHLO's total number of approved chemiluminescent immunoassay reagents in China to 173.

The assay is designed for the qualitative detection of soluble CD146 (sCD146) in human cerebrospinal fluid (CSF), aiding in the diagnosis of complex neurological disorders including multiple sclerosis, neuromyelitis optica spectrum disorder (NMOSD), autoimmune encephalitis, and central nervous system infectious diseases. According to the announcement, sCD146 was identified as an innovative biomarker through research led by the team of Academician Yan Xiyun of the Chinese Academy of Sciences. In neuroinflammatory demyelinating diseases, sCD146 concentrations in CSF are significantly elevated. Compared to traditional biomarkers such as conventional inflammatory factors or metalloproteinases, sCD146 has demonstrated higher sensitivity and specificity in clinical studies, showing potential to provide more reliable laboratory evidence for early detection and differential diagnosis of such complex conditions.

YHLO Biotech was founded in 2008 and focuses on innovation and development in the IVD field, operating five core technology platforms: chemiluminescence immunoassay, biochemistry, indirect immunofluorescence, immunoblotting, and colloidal gold immunochromatography. Its product portfolio covers areas such as autoimmunity, infectious diseases, reproductive health, liver disease, and respiratory testing. With over 300 products widely used in hospitals, health centers, community clinics, and third-party testing centers, YHLO's coverage rate exceeds 66% among top-tier hospitals in China. While firmly established in the Chinese market, YHLO is also expanding its global presence, with products exported to nearly 110 countries and regions across Europe, the Americas, the Middle East, Southeast Asia, and Africa, earning trust and recognition from customers worldwide.