C2N Diagnostics Expands Alzheimer's Blood Test Access Across Asia Through Strategic Partnerships
核心洞察
C2N Diagnostics (搜索) has partnered with BeauBrain Healthcare (搜索) to bring its PrecivityAD2 (搜索)™ blood test to South Korea, where 72% of surveyed physicians indicated willingness to adopt blood-based Alzheimer's diagnostics.
The company also announced a collaboration with Codex Genetics (搜索) to launch the same diagnostic test in Hong Kong, addressing a significant healthcare need in aging Asian populations.
Research published in JAMA demonstrated that the PrecivityAD2 (搜索) test improved diagnostic accuracy compared to standard care, with 91% accuracy, 90% sensitivity, and 92% specificity versus amyloid PET imaging.
C2N Diagnostics (搜索) has announced two major partnerships that will significantly expand access to its breakthrough Alzheimer's disease blood test across Asia, marking a pivotal moment in the region's approach to early dementia diagnosis.
South Korean Market Entry Through BeauBrain Partnership
The specialty diagnostics company has reached an agreement with BeauBrain Healthcare (搜索) to bring its PrecivityAD2 (搜索)™ test to South Korea. The blood test is intended for use in patients 50 and older with signs or symptoms of mild cognitive impairment or dementia, helping physicians detect amyloid plaques in the brain—a pathological hallmark of Alzheimer's disease.
Market readiness appears strong, with 72% of South Korean physicians surveyed during a recent webinar indicating willingness to adopt blood-based Alzheimer's diagnostics once available. Interest extended beyond specialists to include internal medicine and family medicine physicians, suggesting broad clinical adoption potential.
"Early diagnosis is the entry point of successful and effective prevention when it comes to Alzheimer's disease," says BeauBrain co-CEO Jae Hak Kim. "Without an early diagnosis, prevention for further progression cannot happen."
Hong Kong Launch with Codex Genetics
Simultaneously, C2N announced a strategic collaboration with Codex Genetics (搜索), a precision diagnostics company headquartered in Hong Kong, to introduce the PrecivityAD2 (搜索)™ test to healthcare professionals across the territory. This partnership addresses a significant healthcare challenge, as approximately 20% of community-dwelling older adults in Hong Kong have mild neurocognitive impairment and 7.4% are affected by major neurocognitive disorders.
Clinical Validation and Performance Data
The PrecivityAD2 (搜索) test has demonstrated robust clinical performance across multiple studies. Research published in the Journal of the American Medical Association found that the blood test improved diagnostic accuracy of Alzheimer's disease compared to standard of care practice without biomarker testing, with improvements observed in both secondary care and primary care settings.
Additional research published in npj Dementia showed the test achieved 91% accuracy, 90% sensitivity, and 92% specificity using the test's CLIA-established cutoff versus amyloid PET imaging. The test uses high-resolution mass spectrometry to measure plasma amyloid beta (Aβ42/40) ratio and the percentage of phosphorylated tau at threonine-217 (%p-tau217 (搜索)), combining these biomarkers into a proprietary algorithm that yields clear Positive or Negative results.
Addressing Clinical Confounding Factors
Data from the Korea-Registries to Overcome Dementia and Accelerate Dementia Research (K-ROAD) recently reported that C2N's %p-tau217 (搜索) biomarker component is less affected than p-tau217 immunoassays by biological confounding factors such as body weight, renal function, and anemia. This enables more stable and reproducible diagnosis of amyloid pathology in patients presenting with medical comorbidities, findings that have been published in JAMA and JAMA Neurology.
Market Drivers and Regulatory Landscape
The expansion comes at a critical time as both the U.S. Food & Drug Administration and the South Korean Ministry of Food and Drug Safety have recently approved disease-modifying therapies that target the underlying causes of dementia. Previously, Alzheimer's diagnosis required amyloid PET imaging, which had limited accessibility, high cost, and involved radiation exposure.
The FDA has awarded C2N's proprietary brain amyloidosis blood test its Breakthrough Device designation, and it has achieved medical device registration from the United Kingdom's Medicines & Healthcare products Regulatory Agency.
Strategic Investment and Global Expansion
C2N's Asian expansion is supported by significant investment from Samsung (搜索), with the company announcing a $10 million USD investment from Samsung C&T Corporation, Samsung Biologics, Samsung Bioepis, and Samsung Venture Investment Corporation. According to C2N, Samsung's investment bolstered its ability to further scale clinical laboratory services and advanced diagnostic solutions in brain health.
"We endorse BeauBrain's vision for 'a world where all people can be free from the obscure fear of dementia' and are proud they have selected C2N's PrecivityAD2 (搜索) blood test for this partnership," says C2N President and CEO Dr. Joel Braunstein.
BeauBrain Healthcare (搜索), founded by world-renowned scientists and neurologists Dr. Na (Duk L.) and Dr. Seo (Sang Won) from Samsung (搜索) Medical Center, is building a holistic platform for early Alzheimer's disease intervention that encompasses digital cognitive assessments, AI-powered brain imaging analysis, cognitive training, and blood biomarker algorithms powered by C2N.
C2N's assays have been used in over 200 Alzheimer's disease and other research studies throughout the U.S. and globally, with over 90,000 Precivity™-related biomarker measures reported through peer-reviewed publications.