Transforming early Alzheimer’s diagnosis with blood-based biomarkers
Someone in the world develops dementia every 3 seconds. There are over 10 million new cases of dementia each year worldwide, and dementia patients are expected to reach 139 million in 2050. [1] Alzheimer’s disease accounts for 60% to 70% of dementia cases. [2] Regrettably, >90% of patients with MCI (mild cognitive impairment) remain undiagnosed or misdiagnosed in primary care settings. [3] Patients with cognitive impairment often present late in the disease course, missing opportunities for early intervention. [4]
Current gaps in Alzheimer’s assessment
There is a critical unmet need in the Alzheimer’s disease (AD) care pathway: more accessible tests to support initial detection [6]. Early identification of cognitive impairment can significantly improve patient care by enabling timely interventions, treatment and support. [4]
Blood-based biomarkers offer many advantages over CSF and PET biomarkers [5] as they are less invasive, more cost-effective and may help address missed or delayed assessment.
HISCL™ from Sysmex: Fast, precise and scalable diagnosis in 17 minutes
With HISCL™, Sysmex offers a streamlined alternative with blood-based biomarkers to support earlier and more equitable detection of Alzheimer’s disease.
- Studies have shown accuracy of HISCL Aβ42/40 ratio against PET and CSF [7,8]
- Available now: RUO (research use only) access to p-Tau217
- Non-invasive: standard blood draw − no lumbar puncture
- Scalable & adaptable across laboratories and hospitals
- Fast turnaround: get results in 17 minutes
With the help of high-sensitive and fully automated procedures from the Sysmex Automated Immunoassay System (HISCL™), biomarkers for early detection of Alzheimer’s disease can now be measured from blood samples in just 17 minutes.
The HISCL™ β-Amyloid 1-42 and HISCL™ β-Amyloid 1-40 assays are the first CE-marked immunoassay tests released for routine diagnosis.
Additionally, Sysmex p-Tau217 is currently available for RUO.
HISCL: performance that builds confidence
Clinical studies show the HISCL β-amyloid 42/40 ratio performs exceptionally well (AUC 0.895), rivalling more complex imaging methods like PET scans or CSF imaging. [8]
Additionally, since HISCL system is less invasive and more accessible than amyloid PET and cerebrospinal fluid testing, it may contribute to the diagnosis of Alzheimer's disease in routine clinical practice. [7]
In an independent analytical and clinical validation (poster presented at CTAD 2023) of β-Amyloid 1-40, 1-42 and the 1-42/1-40 ratio comparing Quanterix Simoa® and Fujirebio Lumipulse®G, ROC (receiver operator characteristic) results indicated a higher area-under-the curve (AUC) for the HISCL™ assays compared to the other assays. [9].
Sysmex: Science you can rely on
Across haematology, urinalysis and haemostasis, laboratories worldwide rely on Sysmex for precise, reproducible results day after day. Our systems are engineered for productivity and consistent quality – and our customers value the difference this makes in demanding workflows. We pair science with dedicated service: from installation through after-sales support and maintenance, our teams work alongside you to keep your instruments performing at their best.
HISCL-800/5000
Plasma biomarkers, Aβ42/40 and p-tau217, and particularly their ratio (p-tau217/Aβ42), show strong potential as Aβ PET alternatives for AD diagnosis. HISCL-based plasma Aβ42/40 detects Aβ accumulation earlier than Aβ PET visual reading threshold, underscoring its utility as an early diagnostic marker.
Our study demonstrated the utility of plasma Aβ42/40 measured using the fully automated HISCL immunoassay platform in predicting PET-derived Aβ positivity in a diverse patient population and healthy controls. It has the potential to identify early amyloid pathology. Furthermore, the equipment is widely used in clinical settings; hence, it may be used as a large-scale screening tool for the incoming era of AD-modifying therapies.
The plasma Aβ42/Aβ40 ratio measured using the HISCL series achieved high accuracy in predicting amyloid PET status. Since our blood-based immunoassay system is less invasive and more accessible than amyloid PET and cerebrospinal fluid testing, it may contribute to the diagnosis of Alzheimer’s disease in routine clinical practice.
In this study, we developed plasma Aβ40 and Aβ42 immunoassays using a fully automated immunoassay platform that is used in routine clinical practice. In conclusion, we have developed a highly sensitive blood Aβ assay that is feasible for application in routine clinical tests.
Plasma Aβ 42/40 ratio measured by HISCL achieved high accuracy in predicting Aβ pathology determined by CSF testing similarly to the previous report comparing with Amyloid PET in another cohort. This plasma assay may give a useful suggestion to detect Aβ positivity in brain in a less invasive way.
Three group classification allowed our plasma Aβ assay to achieve PPV and NPV ≥90% with 74.4% of participants classifiable as Aβ positive or negative groups. This result indicated that our assay may contribute to reduce amyloid PET scan or CSF Aβ testing, which could be helpful in applications such as the recruitment step of clinical trials However, it should be noted that predictive values and frequency will vary depending on the prevalence of amyloid PET positive participants.
Measurement of Aβ42/40 in plasma samples using a high throughput clinical autoanalyser is now available as an LDT to assist physicians with identifying patients with β-amyloid plaques and the potential presence of Alzheimer’s disease.
