As Alzheimer’s disease enters a new era shaped by disease-modifying therapies, the need for accurate, scalable, and accessible diagnostics has become more urgent than ever. For decades, definitive diagnosis relied on costly amyloid PET imaging or invasive cerebrospinal fluid analysis tools largely confined to specialised centres. ALZpath is helping to change that paradigm through its pTau217 antibody, a blood-based biomarker backed by extensive clinical evidence and now being integrated into leading automated diagnostic platforms worldwide. In this interview, Mike Banville, CEO and President at ALZpath, discusses how pTau217 compares with existing diagnostic standards, the strategic partnership with Siemens Healthineers, the role of high-throughput immunoassay systems such as Atellica in accelerating global adoption, and how blood-based biomarkers are poised to redefine the future of neurodegenerative disease diagnostics.
How does ALZpath’s pTau217 antibody compare with existing PET and CSF-based diagnostics in terms of accuracy, accessibility, and clinical adoption?
ALZpath’s pTau217 antibody represents a paradigm shift in diagnostic accuracy and accessibility, effectively bridging the gap between research-grade precision and clinical utility. Historically, the "gold standard" for Alzheimer’s diagnosis required amyloid PET imaging, which is prohibitively expensive and requires specialised infrastructure, or cerebrospinal fluid (CSF) analysis, which is invasive and often met with patient resistance. By providing a high-performance blood-based alternative, ALZpath allows for the democratisation of Alzheimer's testing, enabling high-confidence screening in primary care settings rather than limiting it to tertiary speciality centres.
What made Siemens Healthineers the right partner for expanding the clinical reach of the pTau217 assay, and how does integration with the Atellica immunoassay systems accelerate global deployment?
Siemens Healthineers offers global scale, established regulatory capabilities, and a large installed base of diagnostic systems already in hospitals and reference laboratories worldwide. This makes it an ideal partner for translating a highly validated biomarker into routine clinical practice. Integration of the pTau217 assay with the Atellica immunoassay systems allows laboratories to run Alzheimer’s testing on existing infrastructure alongside other routine assays. This significantly reduces adoption barriers and enables faster, more consistent global deployment.
Our goal is to work with all the leading in vitro diagnostics (IVD) companies and platforms to maximise global access to the ALZpath pTau217 antibody. Currently, our technology powers assays on the Roche Elecsys® and Beckman Coulter DxI 9000 platforms, both of which have earned FDA Breakthrough Device Designation, among others. By collaborating with these leading companies, we are working towards pTau217 becoming the clinical standard for Alzheimer's diagnostics worldwide.
The pTau217 antibody is supported by more than 90 peer-reviewed studies. How did this depth of clinical evidence influence regulatory confidence and partnerships with large diagnostic players?
The extensive body of peer-reviewed evidence supporting pTau217 provides strong confidence in its analytical reliability and clinical relevance. Consistent findings across independent cohorts and disease stages reduce uncertainty around reproducibility and generalizability, which are key considerations for regulators and diagnostic partners. For large diagnostic companies, this level of validation lowers development risk and supports integration into regulated clinical platforms. It signals that pTau217 is a mature and well-characterised biomarker rather than an emerging or experimental signal.
As disease-modifying therapies for Alzheimer’s become more widely available, how critical is early and scalable diagnosis in ensuring these treatments deliver maximum benefit?
Early and scalable diagnosis is essential to realising the full benefit of disease-modifying Alzheimer’s therapies. Clinical evidence shows that these treatments are most effective when administered before significant neurodegeneration has occurred, making timely identification of eligible patients critical. Blood-based diagnostics such as pTau217 enable earlier detection, broader screening, and more efficient patient selection. This ensures that therapies can be deployed effectively beyond speciality centres and reach patients in routine care settings.
From a laboratory operations perspective, what advantages do high-throughput, automated systems like Atellica offer for routine Alzheimer’s testing in diverse healthcare settings?
High-throughput automated systems support standardisation, efficiency, and consistency across laboratories. Automation reduces hands-on time and variability while enabling laboratories to process large test volumes reliably. Platforms like Atellica also allow Alzheimer’s testing to be incorporated into existing laboratory workflows. This minimises operational complexity and makes routine cognitive biomarker testing feasible in both large reference laboratories and regional healthcare systems.
Looking ahead, how do you see blood-based biomarkers reshaping the future diagnostic pathway for neurodegenerative diseases beyond Alzheimer’s?
Blood-based biomarkers are expected to shift neurodegenerative disease diagnosis toward earlier, biology-based detection rather than symptom-driven confirmation. The success of pTau217 demonstrates how blood testing can support screening, diagnosis, and disease monitoring at scale. This approach is likely to extend to other neurodegenerative conditions such as Parkinson’s disease and frontotemporal dementia. Over time, blood-based biomarkers will enable more precise clinical trials, earlier intervention, and more personalised patient management.
