Sysmex launches HISCL™ platform, enabling faster, scalable Alzheimer's blood testing

HAMBURG, Germany, June 17, 2026 /PRNewswire/ -- Independent European studies presented at CTAD 2025 and ADPD2026 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.

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.

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.

Diagnostic gap

Despite research advances, more than 90% of patients with mild cognitive impairment ( MCI Capital ) 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.

Independently validated by leading research centres

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 doctor 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.

HISCL™ Platform

The HISCL™ system 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.

Key features:

• 17 minutes for sample measurement
• Fully automated, random-access platform requiring no specialist training
• Non-invasive sample collection via standard venous blood draw, with no lumbar puncture
• CE-IVD marked Aβ42/40 ratio assay, available for laboratory use
• HISCL™ p-Tau217 RUO* and HISCL™ p-Tau217 RUO*/Aβ42 assays available under RUO access
• Truly scalable, from major academic centres and memory clinics to district general hospital labs
• Studies demonstrated close performance compared to gold-standard CSF and PET reference methods

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."

For further technical specifications, clinical evidence summaries, and access information for the HISCL™ Alzheimer's biomarker assays, visit: Alzheimer disease

Press contact:

Sysmex Europe SE
Corporate Communications
Ms Saki Aoyagi                                               
Ms Vivien Wieland

Email: pr@sysmex-europe.com
Web: www.sysmex-europe.com

*HISCL™ p-Tau217 assay kit for research use, any diagnostic use is not validated by the legal manufacturer Sysmex Corporation.

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