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

EQS-News: Sysmex Europe SE / Key word(s): Miscellaneous/Miscellaneous Sysmex launches HISCL platform, enabling faster, scalable Alzheimer's blood testing 17.06.2026 / 08:35 CET/CEST The issuer is solely responsible for the content of this announcement. 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) 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.

Schreibe Deinen Kommentar