Sysmex Launches HISCL™ Platform for Rapid, Scalable Alzheimer's Blood Testing with 17-Minute Results
核心洞察
Sysmex Europe SE (搜索) has launched the HISCL™ automated immunoassay platform for Alzheimer's blood biomarker testing, delivering results from a standard venous blood draw in just 17 minutes.
Independent studies presented at CTAD 2025 and ADPD2026 confirmed the HISCL™ p-Tau217 (搜索) RUO and Aβ42/40 ratio (搜索) assays achieved AUROC values above 0.90 for identifying amyloid pathology.
More than 90% of patients with mild cognitive impairment (搜索) remain undiagnosed or misdiagnosed in primary care, a gap the HISCL™ platform aims to close with non-invasive, scalable testing.
HAMBURG, Germany — Sysmex Europe SE (搜索) announced on June 17, 2026 the commercial availability of the HISCL™ automated immunoassay system for Alzheimer's blood biomarker testing, introducing a fully automated platform that delivers results in just 17 minutes from a standard venous blood draw. The launch, supported by independent clinical validation studies presented at the Clinical Trials on Alzheimer's Disease (搜索) (CTAD) 2025 conference and the ADPD Alzheimer's & Parkinson's Disease Conference 2026, marks a significant step toward closing the persistent diagnostic gap in Alzheimer's disease.
The HISCL™ platform offers a non-invasive alternative to traditional diagnostic pathways that rely on cerebrospinal fluid (CSF) analysis via lumbar puncture or positron emission tomography (PET) imaging. The CE-IVD marked Aβ42/40 ratio (搜索) assay is now available for laboratory use, while the HISCL™ p-Tau217 (搜索) RUO and HISCL™ p-Tau217 RUO/Aβ42 ratio assays are accessible under Research Use Only (RUO) status.
A Persistent Diagnostic Gap
Despite advances in Alzheimer's research, more than 90% of patients with mild cognitive impairment (搜索) (MCI) remain undiagnosed or misdiagnosed in primary care settings. These patients frequently present late in the disease course, after early intervention opportunities have narrowed or closed entirely. Current diagnostic methods present significant barriers: lumbar puncture is invasive and resource-intensive, while PET imaging remains expensive and not uniformly available across healthcare systems.
Blood biomarkers are widely recognised as the next step in closing this gap, but reliable measurement requires ultrasensitive technologies capable of delivering consistent results within routine clinical workflows — without the need for specialist infrastructure or bespoke sample handling.
Independent Clinical Validation
The HISCL™ platform's diagnostic performance has been independently validated by two leading European research centres: the Neurochemistry Laboratory at Amsterdam UMC, led by Professor Charlotte Teunissen, and the Sant Pau Memory Unit at Hospital de la Santa Creu i Sant Pau in Barcelona, led by doctor Daniel Alcolea. Each centre employed different patient populations and reference standards, strengthening the generalisability of the findings.
Across studies, the HISCL™ p-Tau217 (搜索) RUO assay and the HISCL™ p-Tau217 RUO/Aβ42 ratio consistently achieved AUROC values above 0.90, demonstrating strong performance across sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). The results support the platform's use as a first-line triage tool for identifying Alzheimer's-related amyloid pathology in both research and clinical settings.
Platform Design and Scalability
The HISCL™ system is engineered for practical deployment in clinical laboratory environments, requiring no dedicated Alzheimer's testing infrastructure. It integrates within existing automated laboratory setups, with a standard blood draw as the only pre-analytical requirement. Key features include fully automated, random-access operation requiring no specialist training, and scalability spanning from major academic centres and memory clinics to district general hospital laboratories.
The studies demonstrated close performance compared to gold-standard CSF and PET reference methods, positioning the platform as a viable front-line screening solution.
Alain Baverel, CEO of Sysmex Europe SE (搜索), stated: "For clinicians and laboratory teams working with patients with cognitive concerns, the diagnostic journey has often meant invasive and time-consuming procedures. The HISCL™ platform changes that. A blood draw and a 17-minute result that is both clinically meaningful and reproducible at scale — this is what we offer to hospitals, memory clinics and laboratories across EMEA."