For many years, confirming the biology of Alzheimer’s disease has relied on tests that are invasive, expensive, difficult to access or all three. Lumbar puncture and positron emission tomography (PET) imaging remain important clinical tools, but they are difficult to deliver at scale, as demand grows for earlier and more accurate diagnosis. This is why the recent regulatory approvals of blood-based biomarkers is such an important step forward for clinicians. Assays such as plasma pTau217 (blood test) offer a more accessible way to identify Alzheimer’s-related pathology when used in the right clinical context.
However, this transition from research into routine clinical practice is more than just about the science. It is also a laboratory, quality and patient safety challenge – as these results will influence diagnosis, treatment decisions and how patients and families plan for the future.
Pharma Lab: Why are safety, quality and compliance critical considerations as Alzheimer’s biomarkers move from research settings into routine clinical use?
Lewis Penny: In research, a biomarker result often sits within a broader exploratory framework. In clinical practice, it becomes part of decision-making for an individual patient. A result may help a clinician judge whether Alzheimer’s pathology is likely, whether further testing is needed, or whether someone may be suitable for treatment or a trial. If that result is wrong, delayed, poorly explained or not traceable, the consequences are very real for patients
That is why safety, quality and compliance must be built in from the beginning. Laboratories need controlled sample handling, validated workflows, clear acceptance criteria, robust quality control and reporting that clinicians can understand and trust. Laboratories must protect the integrity of the whole patient pathway, not simply generate a number.
It is also important to be honest about limitations: pTau217 is a major step forward, but it is not a diagnosis in isolation. Results need to be interpreted alongside clinical history, cognitive assessment, and the wider diagnostic picture.
Pharma Lab: What role does accreditation play in ensuring confidence in biomarker testing and overcoming implementation challenges?
Lewis Penny: Accreditation provides an independent framework for showing that a laboratory is competent, controlled and working to recognised standards. For Alzheimer’s biomarker testing, that is vital. These tests are moving quickly, public interest is high and accreditation helps ensure enthusiasm is matched by discipline.
In practical terms, accreditation makes you examine the full pathway: sample collection, transport, receipt, processing, storage, analysis, authorisation, reporting, staff competence, equipment maintenance, audit and risk management. It changes the question from ‘can you run this assay?’ to ‘can you run this assay reliably, repeatedly and safely for clinical use?’
Pharma Lab: What are the most common bottlenecks laboratories encounter when implementing a new biomarker testing service?
Lewis Penny: One major bottleneck is access to well-characterised samples. To validate or verify a biomarker assay properly, you need samples linked to reliable clinical information and, ideally, comparator methods such as cerebrospinal fluid or imaging. Without them, it is difficult to define performance, understand borderline results or build confidence in the service.
Another challenge is translating a research process into a clinical service. In research, some flexibility is often possible. In clinical testing, variation must be controlled. Tube type, centrifugation, time to processing, freeze-thaw history and storage temperature can all affect the result, especially with Alzheimer’s biomarkers.
There are also operational bottlenecks: procurement, analyser capacity, staff training, IT configuration, result coding, referral criteria, turnaround expectations and clinical education. They are often the difference between a smooth launch and a service that struggles.
Pharma Lab: What practical lessons have you learned about introducing new laboratory services while maintaining high standards of quality and compliance?
Lewis Penny: The main lesson is to slow down at the right points. There is pressure to move quickly, especially in Alzheimer’s disease, but speed without control creates risk. Early planning pays off:
• map the workflow
• identify failure points
• document decisions
• train people properly.
It is also important to involve the right people early. A new cost-effective and high-quality biomarker service is a concert that touches quality, clinical teams, business development, IT, finance and engagement teams. If those groups are brought in too late, small issues become late-stage blockers. If they are involved from the start, the service is stronger and the launch is smooth.
Pharma Lab: How can standardised technologies and validated workflows help reduce implementation risks and accelerate adoption?
Lewis Penny: Standardised technologies reduce unnecessary variation. Automated immunoassay platforms and defined reagent systems make it easier to control performance and platforms that are already used and embedded in healthcare will accelerate adoption.
Validation is where the laboratory earns confidence. It should show that the assay performs as expected in the intended setting, with the intended sample type, population and workflow. That gives scientists, clinicians, quality teams and external partners a shared understanding of how the result is produced and where the limitations sit. Cut-offs for positive, indeterminate and negative pathology and test limitations, are initially established through cohort studies, but validation should be an ongoing process. As these tests enter real-world practice, performance should be continually reviewed across diverse patient populations and clinical settings to ensure they remain robust, reliable and clinically meaningful.
Pharma Lab: What role do collaboration and communication play in overcoming project bottlenecks between laboratory, clinical and quality teams?
Lewis Penny: Collaboration and communication are central. Many implementation problems are not caused by a lack of scientific knowledge; they are caused by assumptions. The laboratory may assume clinicians understand pre-analytical requirements. Clinicians may assume every result can be interpreted as positive or negative. Quality teams may assume every operational change has been risk assessed. Good communication brings those assumptions into the open early.
Education is a big part of this. Laboratories need to help clinicians understand the intended use of the test, what an intermediate or borderline result may mean and when further assessment is required. Equally, lab teams need to understand the pressures clinicians face and the questions patients are asking.
Pharma Lab: How important is data integrity and traceability in modern biomarker testing services, and what challenges do laboratories face in this area when scaling whilst maintaining quality?
Lewis Penny: For a biomarker result to be clinically meaningful, the laboratory must be able to trace the sample, method, analyser, reagent lot, quality control, staff involvement and final authorisation. This becomes tougher as services scale, especially when samples arrive from different sites, partners or clinicians. Manual workarounds may be acceptable during early development, but they are not sustainable for routine clinical services at scale. Scaling is not simply doing more tests; it is doing more tests with the same level of control and not sacrificing quality.
Pharma Lab: How do you see the future of Alzheimer’s biomarker testing evolving, and what will laboratories need to do to support wider clinical adoption?
Lewis Penny: The future is what excites me most. The biology of Alzheimer’s can be evident at least a decade before symptoms, creating an opportunity to detect disease earlier and, with emerging treatments, intervene before dementia develops.
I think we will move beyond simple yes/no answers on amyloid and tau towards biological signatures. By monitoring co-pathologies, neurodegeneration and other markers, increasingly through multiplexed testing, we could understand not just whether pathology is present, but what it means for an individual patient and their likely disease trajectory.
Crucially, this needs to move beyond specialist centres. As technologies become standardised and automated, biomarker testing should become increasingly routine and part of primary care.
For laboratories, this will require scale, standardisation and above all quality. We need to adopt new technologies quickly enough to support this transformation, but with rigorous validation, traceability and quality systems. The challenge is to move fast without compromising the confidence that clinical testing demands. •
