Home KingMed Establishes Reference Intervals for Domestic Chemiluminescence AD Platform with No Statistical Difference from Imported Single-Molecule Systems

KingMed Establishes Reference Intervals for Domestic Chemiluminescence AD Platform with No Statistical Difference from Imported Single-Molecule Systems

Oct 16, 2026 08:08 CST Updated 10:35
KingMed Diagnostics

Third-Party Medical Testing and Pathological Diagnosis Service Provider

When a 68-year-old retired teacher in southern China's Guangdong province worried about memory lapses last year, her local clinic couldn't offer the specialized Alzheimer's screening she needed. The test required expensive imported equipment and a trip to a major city hospital—costing hundreds of dollars and a full day's travel.

That barrier may soon fall. On October 15, 2026, KingMed Diagnostics Group Co., Ltd. announced it has completed a critical step toward making Alzheimer's blood testing accessible across China: establishing reference intervals for four core biomarkers using a domestic chemiluminescence platform.

The work matters because early detection of Alzheimer's disease has long depended on costly technology controlled by foreign manufacturers. KingMed's achievement means Chinese laboratories can now run the same tests—measuring P-tau181, P-tau217, Aβ42, and Aβ40 in blood—on equipment built at home.

No Statistical Difference

The company's validation study found the domestic platform's diagnostic performance matched imported single-molecule systems. The area under the receiver operating characteristic curve—a measure of accuracy—ranged from 0.88 to 0.94 across the four biomarkers. That result showed no statistically significant difference compared to the imported technology.

"The key indicators demonstrate good comparability," the company disclosed, suggesting Chinese labs can achieve equivalent results without relying on foreign platforms.

Cost Cuts of 50% to 70%

The economics matter as much as the science. Alzheimer's blood testing using imported single-molecule platforms has remained prohibitively expensive for most Chinese patients. KingMed's domestic approach reduces reagent costs by 50% to 70%, according to the company.

That price drop could open screening to county-level hospitals and regional testing centers—facilities that serve hundreds of millions of rural and suburban Chinese but lack the budgets for imported equipment.

Scale and Speed

The domestic platform also handles volume. KingMed reports daily throughput of hundreds to thousands of samples, making it suitable for large-scale population screening programs. China's aging population—projected to reach 400 million by 2035—makes such capacity essential.

The company paired its technical work with a quality management system covering the entire testing process: sample collection, centrifugation, cold-chain transport, and laboratory analysis. Low-abundance proteins like those used in Alzheimer's testing require strict handling protocols to maintain accuracy.

What Comes Next

KingMed has established the reference intervals and validated performance. The next question is adoption. Will Chinese hospitals and testing centers switch from imported systems? Will regulators accept the domestic platform's results for clinical decision-making?

For the retired teacher in Guangdong, the answer could mean an Alzheimer's screening at her neighborhood clinic—without the day-long trip to Guangzhou or Shenzhen, and at a fraction of the current cost.

The technology is ready. The system now must catch up.