ASCO 2025

Authors: Nikita Shah & Nikita Walker, Beyond Blue

Historically, Alzheimer’s disease has been diagnosed once cognitive symptoms become noticeable and begin affecting daily life. By that stage, the underlying pathology of the disease may have been developing for years, or even decades. Advances in biomarkers are creating the possibility of identifying Alzheimer’s disease pathology years before an individual receives a formal dementia diagnosis, opening the door to earlier intervention and potentially improved long-term outcomes.

For Alzheimer’s disease awareness month, we reflect on the growing discussion in the field, which is shifting the mindset from a reactive care pathway (Dementia-type symptoms → Assessment → AD Diagnosis → Treatment) towards a more preventative one (Risk Identification → Biomarker Testing → AD Diagnosis → Early Treatment Intervention).

Blood-based biomarkers are changing that paradigm.

Today, biomarkers are typically tested for through neuroimaging or cerebrospinal fluid testing, but blood-based biomarkers have recently drawn significant attention given the need for more widely accessible, non-invasive and cost-effective diagnostic options1,2. The recently FDA-cleared single-biomarker blood test, p-tau217, shows promise, with high levels being predictive of future cognitive decline over 10 years3,4. While not diagnostic on its own, p-tau217 adds to growing evidence that Alzheimer’s-related changes begin years before symptoms appear. This early biological signal may provide a valuable window for intervention1,5. Are these patients already showing the earliest stage of Alzheimer’s, and if so, how should they be managed?

Disease-modifying therapies are increasing the value of early diagnosis but do we have the tools and systems to act?

The shift from reactive to proactive and preventative care is being driven, in part, by the arrival of disease-modifying therapies. The anti-amyloid treatments appear to deliver the greatest benefit in the early stages of disease, with several trials ongoing investigating effects in preclinical (non-symptomatic) Alzheimer’s. However, in practice, many experience real-world delays in initiating approved therapies, due to a range of clinical and practical factors such as accurate diagnosis, genotype, referral pathways and insurance status6. The challenge is no longer solely the development of effective therapies but ensuring that eligible patients are identified early enough to benefit from them.

Health systems now face a new challenge: identifying the right patients at the right time.

As the focus shifts towards earlier intervention, an important question remains: who should be tested? Should biomarker testing be reserved for people already experiencing cognitive symptoms, offered to those with mild cognitive impairment (MCI), or extended to individuals with known risk factors such as family history or genetic predisposition? OR… could biomarker testing eventually become part of routine healthy aging assessments for everyone? 

Blood-based biomarkers have the potential to expand Alzheimer’s assessment beyond specialist memory clinics by improving diagnostic accuracy in both primary and secondary care settings7. However, translating this potential into routine practice will require healthcare systems to establish clear testing pathways, standardize interpretation of results, develop referral processes, and ensure appropriate patient support and follow-up services are in place.

We can increasingly identify Alzheimer’s disease earlier. But are healthcare systems, physicians, patients, and caregivers ready for what comes next?

Earlier detection is creating new opportunities for pharmaceutical companies, but also new questions. As blood-based biomarker testing becomes more accessible, success will depend not only on developing effective therapies, but also on understanding who should be tested, how diagnostic pathways will evolve, and what barriers may impact patient identification, referral, testing, and treatment initiation. Understanding how healthcare professionals, patients, caregivers, and payers navigate this evolving diagnostic landscape will be critical to supporting adoption, reducing barriers to access, and ensuring advances in diagnosis translate into meaningful patient outcomes.

The direction of travel is clear. Rather than waiting for symptoms to progress, the goal is increasingly to identify individuals at risk and intervene earlier in the disease journey. This year, Alzheimer’s awareness is more than just recognizing symptoms. It is about understanding how advances in biomarkers, diagnostics, and treatment are reshaping the path from risk identification to intervention.

 

 

References:

  1. Suárez-Calvet, M., Salvadó, G., de Fortuny, B.B. and del Campo, M. (2026). Blood biomarkers for Alzheimer’s disease: from detection to decisions. The Lancet, [online] 407(10544), pp.2151–2154. doi:10.1016/s0140-6736(26)00909-8.
  2. Assfaw, A.D., Schindler, S.E. and Morris, J.C. (2024). Advances in blood biomarkers for Alzheimer disease (AD): A review. The Kaohsiung journal of medical sciences, doi:10.1002/kjm2.12870.
  3. Early AAIC, B.T.P.A.R.D. (2026). Blood Test Predicts Alzheimer’s Risk a Decade Early | AAIC. [online] Blood Test Predicts Alzheimer’s Risk a Decade Early | AAIC. Available at: https://aaic.alz.org/releases-2026/blood-test-p-tau217-predicts-alzheimers-risk.asp [Accessed 3 Sept. 2026].
  4. Roche.com. (2026). Roche receives FDA clearance for Elecsys® pTau217, advancing Alzheimer’s disease assessment across primary and specialty care. [online] Available at: https://www.roche.com/investors/updates/inv-update-2026-08-24 [Accessed 10 Sept. 2026].
  5. Jia, J., Ning, Y., Chen, M., Wang, S., Yang, H., Li, F., Ding, J., Li, Y., Zhao, B., Lyu, J., Yang, S., Yan, X., Wang, Y., Qin, W., Wang, Q., Li, Y., Zhang, J., Liang, F., Liao, Z. and Wang, S. (2024). Biomarker Changes during 20 Years Preceding Alzheimer’s Disease. New England Journal of Medicine, 390(8), pp.712–722. doi:10.1056/nejmoa2310168.
  6. Rosenbloom, M., Singh, D. and Schnee, A. (2026). Real-world Delays in Anti-amyloid Therapy Initiation Following Diagnosis of Early-stage Alzheimer’s Disease (S1.007). Neurology, 106(11_Supplement_1). doi:10.1212/wnl.0000000000217298.
  7. Blood Test Improves Accuracy of Alzheimer’s Diagnosis | AAIC. (2026). Blood Test Improves Accuracy of Alzheimer’s Diagnosis | AAIC. [online] Available at: https://aaic.alz.org/releases-2026/alzheimers-blood-test-accurate-diagnosis-pcp.asp [Accessed 3 Sept. 2026].