Sysmex Europe has launched its HISCL automated immunoassay platform for Alzheimer’s disease blood biomarker testing, offering laboratories a faster alternative to cerebrospinal fluid (CSF) analysis and PET imaging for the identification of amyloid pathology.

The company said the system can deliver results from a routine blood sample in 17 minutes and is designed to operate within existing laboratory workflows without requiring dedicated Alzheimer’s testing infrastructure.

The launch follows the presentation of data from independent European studies at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting and the Alzheimer’s & Parkinson’s Disease Conference (ADPD), which evaluated the performance of the HISCL p-Tau217 assay and the HISCL Aβ42/40 ratio assay.

According to Sysmex, the studies demonstrated strong diagnostic accuracy for identifying amyloid pathology associated with Alzheimer’s disease using standard venous blood samples.

The announcement comes as healthcare systems seek less invasive methods to identify patients who may be developing Alzheimer’s disease. Current diagnostic pathways often rely on lumbar punctures to obtain CSF samples or PET imaging scans, both of which can be resource intensive and may not be readily accessible in all healthcare settings.

Early diagnosis has become increasingly important as new therapies targeting the underlying biology of Alzheimer’s disease emerge and as clinicians look to identify patients earlier in the course of disease progression.

Sysmex said more than 90% of patients with mild cognitive impairment are either undiagnosed or misdiagnosed in primary care settings, highlighting what many researchers describe as a significant diagnostic gap.

The company cited independent validation studies conducted by researchers at Amsterdam UMC and Hospital de la Santa Creu i Sant Pau in Barcelona. The investigations assessed the ability of blood-based biomarkers to identify amyloid pathology and reported strong performance across measures of sensitivity and specificity.

The HISCL Aβ42/40 ratio assay is available with CE-IVD marking for laboratory use, while the HISCL p-Tau217 assay and the HISCL p-Tau217/Aβ42 assay are currently available under Research Use Only access.

The platform has been designed for deployment across a range of laboratory settings, from academic medical centres and specialist memory clinics to district general hospitals.

Alain Baverel, chief executive officer of Sysmex Europe, 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.”

Interest in blood-based biomarkers for Alzheimer’s disease has increased significantly in recent years as researchers seek scalable approaches that could support earlier detection and improve access to diagnostic testing. Several diagnostic developers and healthcare organisations are evaluating how blood biomarker testing may complement or reduce reliance on more invasive and costly diagnostic methods.

The availability of the HISCL platform adds to a growing field of blood-based diagnostic technologies aimed at helping clinicians identify patients who may benefit from further assessment or treatment for Alzheimer’s disease.