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.
Attachments:
MORE NEWS
YHLO Joins BSI’s 125th Anniversary Gala in London
On April 23, YHLO Founder Mr. Hu Deming and Chairman Mr. Hu Kunhui attended BSI's 125th anniversary gala in London as the only Chinese IVD representatives.
2026-04-28
Meet YHLO PIFI: Smarter Islet Function Assessment
Launched on April 10 at the 2026 Islet Metabolism Forum in Nanjing, the YHLO PIFI Intelligent Computing Model marks a major step forward in diabetes care.
2026-04-14
2026 YHLO Global Partners Conference: Intelligent Automation · Infinite Potential
On March 30, 2026, YHLO Global Partners Conference was grandly held in Changsha.
2026-04-03
Add: Building 1, YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict, Longgang District, 518116 Shenzhen, P.R.China
