Alzheimer’s disease testing

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Alzheimer's doesn't wait. Neither should a diagnosis.

Roche’s Alzheimer’s testing portfolio: Comprehensive CSF and blood-based solutions across the care pathway

At Roche Diagnostics, we focus on solutions that accelerate the detection of neurodegenerative diseases. For almost two decades, Roche has been working tirelessly to develop different technologies to detect and aid in the diagnosis of Alzheimer’s and other neurological diseases. Our tools, including blood-based tests and CSF assays, aim to more effectively detect and aid clinicians in helping diagnose the disease, and support better clinical decisions across the disease pathway.

Currently, significant barriers delay a final and accurate diagnosis.4,5 Patients often face challenges related to lack of awareness and disease stigma, while healthcare professionals contend with heterogeneous diagnostic workups, a lack of specialized training in primary care, and capacity constraints among neurologists.4,5 Triage and timely detection remain the primary bottlenecks in the patient pathway, highlighting the urgent need for more accessible and efficient diagnostic solutions.4,5

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Neurological conditions represent a significant global health and socioeconomic challenge, with over 7 million people living with Alzheimer’s in the U.S.1
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Each year, approximately 1 in 3 older adults dies with Alzheimer’s or another form of dementia.
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According to the CDC, Alzheimer’s is the 6th leading cause of death in the US.2
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Alzheimer’s disease (AD) is the most common cause of dementia, with the global dementia prevalence projected to triple to 153 million by 2050.1,3
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The urgency of this crisis is underscored by the fact that someone in the world develops dementia every three seconds.3

Changes in specific biomarkers for Alzheimer’s disease can be an early indicator of pathology6,7

The accumulation of abnormal amyloid beta in plaques and tau in neurofibrillary tangles are regarded as the pathological hallmarks of Alzheimer’s.6,7 Changes in both amyloid and tau biomarker proteins start decades before the onset of symptoms and can be detected by a fluid biomarker test (blood or CSF) or imaging (amyloid and tau PET).6,7

Dynamic biomarkers of Alzheimer's pathological cascade

Roche Diagnostics' four neurology focus areas:

ICON-alzheimers
Alzheimer's
ICON-multiple-sclerosis
Multiple Sclerosis*
ICON-parkinsons
Parkinson’s*
ICON-traumatic-brain-injury
Traumatic Brain Injury (TBI)*

*Products are in development and not for sale in the U.S.

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Elecsys® pTau181 blood test helps rule out amyloid pathology, streamlining Alzheimer’s diagnosis with early, accessible, and cost-effective screening.
Elecsys β-Amyloid (1-42) CSF II and Elecsys Phospho-Tau (181P) CSF are in vitro electrochemiluminescence immunoassays for the measurement of the β-Amyloid (1-42) (Abeta42) and Phospho-Tau (181P) (pTau181) protein concentrations in cerebrospinal fluid (CSF) from adult patients aged 55 years and older being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment to generate a pTau181/Abeta42 ratio value.
Elecsys β-Amyloid (1-42) CSF II and Elecsys Phospho-Tau (181P) CSF are in vitro electrochemiluminescence immunoassays for the measurement of the β-Amyloid (1-42) (Abeta42) and Phospho-Tau (181P) (pTau181) protein concentrations in cerebrospinal fluid (CSF) from adult patients aged 55 years and older being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment to generate a pTau181/Abeta42 ratio value.
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References

  1. Alzheimer’s Association. (2026). 2026 Alzheimer’s disease facts and figures. https://www.alz.org/getmedia/ef8f48f9-ad36-48ea-87f9-b74034635c1e/alzheimers-facts-and-figures.pdf. Last accessed October 2026.
  2. Xu, J., Murphy, S. L., Kochanek, K. D., & Arias, E. (2026). Mortality in the United States, 2024 (NCHS Data Brief No. 548). Centers for Disease Control and Prevention. https://www.cdc.gov/nchs/data/databriefs/db548.pdf. Last accessed October 2026.
  3. GBD 2019 Dementia Forecasting Collaborators. (2022). Estimation of the global prevalence of dementia in 2019 and forecasted prevalence in 2050: An analysis for the Global Burden of Disease Study 2019. The Lancet Public Health, 7(2), e105-e125. doi:10.1016/S2468-2667(21)00249-8
  4. University College London. (2025, July). Dementia takes 3.5 years to diagnose after symptoms begin. UCL News. https://www.ucl.ac.uk/news/2025/jul/dementia-takes-35-years-diagnose-after-symptoms-begi. Last accessed October 2026.
  5. Alzheimer's Disease International. (2021). World Alzheimer Report 2021: Journey through the diagnosis of dementia. https://www.alzint.org/resource/world-alzheimer-report-2021/. Last accessed October 2026.
  6. Jack, C. R., et al. (2013). Tracking pathophysiological processes in Alzheimer's disease: An updated hypothetical model of dynamic biomarkers. The Lancet Neurology, 12(2), 207–216. doi:10.1016/S1474-4422(12)70291-0
  7. Bloom, G. S. (2014). Amyloid-β and tau: The trigger and bullet in Alzheimer disease pathogenesis. JAMA Neurology, 71(4), 505–508. doi:10.1001/jamaneurol.2013.5847