YHLO Secures Approval for the World’s First sCD146 CLIA Assay
Recently, YHLO has obtained approval from the Guangdong Medical Products Administration for its soluble CD146 (sCD146) CLIA assay, marking a major milestone in central nervous system (CNS) disease diagnostics. YHLO is now the first company worldwide to offer an sCD146 test for cerebrospinal fluid, bringing its total CLIA assay portfolio in China to 173.
sCD146 is a highly sensitive biomarker linked to neuroinflammation and blood-brain barrier disruption, showing significantly elevated levels in disorders such as multiple sclerosis(MS) and neuromylitis optica. Current laboratory indicators often lack sensitivity, specificity, or operational efficiency. YHLO’s chemiluminescence-based method overcomes these limitations with simplified workflow, fast detection, and superior analytical performance.
Research highlights:
1. Sensitive marker of neuroinflammation: CSF sCD146 demonstrated an AUC of 0.9962 for detecting BBB damage.
2. Novel indicator for active MS: sCD146 outperformed conventional markers and correlated strongly with multiple disease-related antibodies.
Developed jointly with academician Prof. Yanxi Yun, this first-in-class assay represents a breakthrough in the precision diagnosis of CNS demyelinating diseases, reinforcing China’s leadership in the field. YHLO is currently conducting multi-center studies and expanding sCD146 research across obstetrics, autoimmunity, cardiovascular diseases, and oncology.
In the future, YHLO will remain committed to advancing standardized, accessible, and clinically meaningful diagnostics for global healthcare.
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YHLO Secures Approval for the World’s First sCD146 CLIA Assay
YHLO has obtained approval from the Guangdong Medical Products Administration for its soluble CD146 (sCD146) CLIA assay, marking a major milestone in central nervous system (CNS) disease diagnostics. YHLO is now the first company worldwide to offer an sCD146 test for cerebrospinal fluid, bringing its total CLIA assay portfolio in China to 173.
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