Alzheimer’s disease continues to remain one of the most underdiagnosed neurological disorders globally, with many patients experiencing long delays between the onset of cognitive symptoms and definitive diagnosis. As healthcare systems increasingly shift toward earlier intervention and precision medicine, blood-based biomarkers are emerging as a potentially transformative tool in Alzheimer’s diagnostics.
Recent advancements around pTau217 assays are drawing significant attention for their ability to detect amyloid pathology through minimally invasive blood testing, offering an alternative to traditional diagnostic methods such as PET imaging and cerebrospinal fluid (CSF) analysis. Industry experts believe these innovations could help enable earlier detection, improve accessibility and streamline patient triage across both primary and specialist care settings.
In this interview with MedTech Spectrum, Mike Banville, CEO & President of ALZpath, discusses the growing role of blood-based biomarkers in reshaping Alzheimer’s disease diagnosis, the clinical significance of early amyloid detection, the challenges around broader adoption in routine healthcare practice, and how standardisation could help accelerate earlier intervention and treatment pathways.
The Elecsys pTau217 assay is being described as a major step toward earlier and more accessible Alzheimer’s diagnosis. How do you see blood-based biomarkers transforming the current diagnostic pathway compared to PET scans and CSF testing?
From ALZpath’s perspective, the broader significance of blood-based biomarkers lies in their potential to fundamentally improve accessibility and scalability in Alzheimer’s disease diagnostics.
pTau217 has emerged as one of the most reliable blood-based biomarkers for detecting Alzheimer’s disease-related pathology. Its growing adoption across both research and clinical settings reflects increasing confidence in its ability to identify underlying amyloid pathology.
Historically, amyloid PET imaging and cerebrospinal fluid (CSF) analysis have been important tools for detecting Alzheimer’s pathology, but both remain limited by cost, accessibility, infrastructure requirements, and invasiveness. PET imaging is expensive and capacity-constrained, while CSF collection requires lumbar puncture, which may not be appropriate or accessible for all patients.
Blood-based biomarkers, particularly pTau217, are increasingly demonstrating strong concordance with these established modalities. The opportunity is not necessarily to replace PET or CSF entirely, but to enable a scalable, blood-first diagnostic pathway that can identify patients earlier and help triage those who may benefit from specialist evaluation or confirmatory testing.
Roche has highlighted that the same test cutoffs can be applied across both primary and secondary care settings. What impact could this standardisation have on improving diagnostic confidence and reducing delays in referral and treatment?
While Roche is best positioned to comment on the specifics of its assay, standardisation will likely be an important enabler of broader clinical adoption for blood-based Alzheimer’s testing.
One of the major challenges in diagnostic pathways today is variability in interpretation across care settings. If clinicians can apply consistent thresholds and decision-making frameworks across both primary and specialist care, it could improve diagnostic confidence, simplify workflows, and reduce uncertainty around referral decisions.
Today, many patients experience significant delays between initial cognitive concerns and specialist assessment, often waiting months or longer for neurology appointments and confirmatory testing. A standardised blood-first approach could support earlier triage in primary care, helping prioritise patients who may require further evaluation while reducing system-wide delays.
Alzheimer’s disease remains significantly underdiagnosed worldwide, with many patients waiting years after symptom onset before receiving a diagnosis. In your view, what are the biggest barriers to wider adoption of blood-based testing in routine clinical practice?
While the scientific progress around blood-based biomarkers has advanced rapidly, broad clinical adoption depends on several interconnected factors.
First, clinicians need robust real-world clinical validation in addition to strong research data to build confidence in performance across diverse patient populations and healthcare settings. Analytical performance alone is not sufficient.
Second, regulatory approval and reimbursement pathways will be critical. Even highly accurate tests require clear positioning and payer coverage to achieve widespread adoption.
Third, successful integration into healthcare systems is essential. Clinicians need practical guidance around interpretation, follow-up actions, and how blood-based testing fits within existing diagnostic and treatment pathways.
The assay was validated in individuals at very early stages of cognitive decline, including Subjective Cognitive Decline and Mild Cognitive Impairment. Why is identifying amyloid pathology at these early stages clinically important for patients and caregivers?
Earlier identification of amyloid pathology has the potential to fundamentally reshape Alzheimer’s disease management by enabling intervention earlier in the disease continuum.
Historically, many patients have been diagnosed only after more substantial cognitive decline, despite evidence that Alzheimer’s pathology begins years before dementia symptoms become apparent.
Detecting pathology at earlier stages, including mild cognitive impairment, may allow patients to enter confirmatory diagnostic and treatment pathways sooner, when interventions could have greater potential impact. This is becoming increasingly relevant as disease-modifying therapies such as Kisunla and Leqembi continue to emerge for earlier-stage patients.
For patients and caregivers, earlier identification can also provide greater clarity and reduce uncertainty, supporting more informed planning, monitoring, and care discussions before symptoms significantly progress.
Roche collaborated with Eli Lilly on the development of the pTau217 assay. How important are such industry collaborations in accelerating innovation and expanding access to precision diagnostics in neurodegenerative diseases?
Neurodegenerative diseases are highly complex, and no single organisation can solve the diagnostic and therapeutic challenges alone. Collaboration across diagnostics, therapeutics, biomarker development, and healthcare systems will be critical to accelerating progress.
These partnerships help bridge the gap between scientific discovery, assay development, regulatory pathways, and real-world clinical implementation. As precision medicine continues to evolve in Alzheimer’s disease, diagnostics and therapeutics are becoming increasingly interconnected.
Looking ahead, how do you envision blood-based Alzheimer’s diagnostics influencing future treatment strategies, clinical trial enrollment, and overall healthcare system preparedness for the growing dementia burden?
Over the next five to ten years, blood-based biomarkers are expected to become increasingly integrated into routine Alzheimer’s care, clinical research, and therapeutic development.
From a treatment perspective, earlier and more scalable identification of amyloid pathology could support earlier intervention and more personalised care pathways, particularly as disease-modifying therapies continue to evolve.
In clinical research, blood-based testing is already improving trial efficiency by enabling faster, less invasive screening and longitudinal monitoring. This may expand access to clinical trial participation by identifying eligible individuals earlier and more efficiently than traditional approaches alone.
At the healthcare system level, the growing global dementia burden will require more scalable infrastructure than specialist-led diagnosis alone can support. Blood-first diagnostic pathways could help reduce bottlenecks by shifting earlier assessment into primary care settings, while reserving specialist resources for patients who require confirmatory evaluation and treatment planning.
Ultimately, broader impact will depend on continued progress across regulatory approval, reimbursement, and clinical guideline adoption. As these elements align, Alzheimer’s care may increasingly shift from a reactive diagnosis model toward a more proactive and longitudinal model of disease management.
