Blood-Based Alzheimer’s Testing Platform Offers Rapid Results

Accurate identification of Alzheimer’s disease pathology often relies on cerebrospinal fluid analysis or positron emission tomography, which can be invasive, costly, and not widely accessible. In primary care, more than 90% of patients with mild cognitive impairment remain undiagnosed or misdiagnosed, often missing opportunities for early intervention. A new system now enables laboratories to perform blood-based Alzheimer’s biomarker testing with a 17-minute turnaround, supported by independent European validation demonstrating high diagnostic performance.

Sysmex Europe SE (Hamburg, Germany) has introduced the HISCL automated immunoassay system for Alzheimer’s blood biomarker testing. The platform is available for laboratory use with a CE‑IVD–marked amyloid beta (Aβ) 42/40 ratio assay, and access to the HISCL p‑Tau217 assay under Research Use Only (RUO). Positioned as a fully automated and non‑invasive alternative to traditional cerebrospinal fluid (CSF) and positron emission tomography (PET) pathways, the system is supported by clinical data from independent research centers.

Image: The HISCL automated immunoassay system offers a streamlined blood-based biomarker approach to support earlier, more equitable Alzheimer’s disease detection (Photo courtesy of Sysmex)

The HISCL platform is a random‑access automated immunoassay system designed to fit into existing laboratory workflows without dedicated Alzheimer’s testing infrastructure or specialist training. A standard venous blood draw is the only pre‑analytical requirement, and individual sample measurement is completed in 17 minutes. The system is intended to scale from major academic centers and memory clinics to district general hospital laboratories, enabling broad deployment within routine settings.

Independent European studies presented at the Clinical Trials on Alzheimer’s Disease (CTAD) 2025 and ADPD 2026 conferences confirmed the performance of the HISCL p-Tau217 RUO and Aβ42/40 ratio assays for identifying amyloid beta pathology. Validation studies conducted by the Neurochemistry Laboratory at Amsterdam UMC and the Sant Pau Memory Unit in Barcelona, using different patient populations and reference standards, demonstrated strong analytical and diagnostic performance.

Across studies, the HISCL p-Tau217 RUO and p-Tau217/Aβ42 assays consistently achieved area under the receiver operating characteristic curve (AUROC) values above 0.90, with results closely aligned to cerebrospinal fluid and positron emission tomography reference methods. These findings support the platform’s potential use as a first-line triage tool for Alzheimer’s-related amyloid pathology in both research and clinical settings.

The HISCL p-Tau217 assay kit is for research use only and has not been validated by the manufacturer for diagnostic use. By combining rapid turnaround, automated operation, and independently validated performance, the platform is intended to help address diagnostic gaps where invasive or resource-intensive methods limit timely assessment.

“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.” said Alain Baverel, CEO, Sysmex Europe SE.