Sysmex Europe SE has announced the availability of the HISCL automated immunoassay system for Alzheimer's blood biomarker testing, offering a fast, fully automated and non-invasive alternative to traditional CSF- and PET-based pathways.
Supported by clinical data from independent research centres, the HISCL platform is now available for laboratory use, with the CE-IVD marked Aβ42/40 ratio assay and HISCL p-Tau217 RUO accessible under Research Use Only (RUO) access.
Independent European studies have confirmed that the HISCL p-Tau217 RUO and the HISCL Aβ42/40 ratio are highly accurate for early identification of Aβ pathology. By using a routine blood draw, results are available in just 17 minutes. The findings were recently presented at the Clinical Trials on Alzheimer's Disease (CTAD) and the ADPD Alzheimer's & Parkinson's Disease Conference and demonstrate a strong analytical and diagnostic performance across sensitivity, specificity, and predictive values using a standard venous blood sample.
Despite research advances, more than 90% of patients with mild cognitive impairment (MCI) remain undiagnosed or misdiagnosed in primary care, frequently presenting late in the disease course after early intervention opportunities have narrowed or closed. Lumbar puncture is invasive and resource-intensive, presenting barriers for clinicians, while PET imaging is expensive and not uniformly available.
Blood biomarkers are widely recognised as the next step in closing this gap. But a reliable measurement of blood biomarkers requires ultrasensitive technologies, capable of delivering reliable results within routine workflows, without specialist infrastructure or bespoke handling.
The HISCL platform's diagnostic performance has been independently validated by leading research centres – the Neurochemistry Laboratory, Amsterdam UMC, led by Professor Charlotte Teunissen, and Sant Pau Memory Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, led by Dr Daniel Alcolea – each using different patient populations and reference standards.
Across studies, HISCL p-Tau217 RUO and the HISCL p-Tau217 RUO /Aβ42 ratio consistently achieved AUROC values above 0.90, with strong performance across sensitivity, specificity, PPV, and NPV. The results support the use of the platform as a first-line triage tool for Alzheimer's-related amyloid pathology in both research and clinical settings.
The HISCL system (pictured above) is engineered for practical deployment in clinical laboratory environments, with no dedicated Alzheimer's testing infrastructure required. HISCL works within existing automated setups, with a standard blood draw as the only pre-analytical requirement.
Alain Baverel, CEO, Sysmex Europe SE, said: "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."