Innovative diagnostics accelerating early detection of Alzheimer’s
A growing public health crisis
Dementia encompasses a range of progressive brain conditions — and in the UK, it's one of the most pressing health challenges we face.1,2. The scale of the challenge in the UK is significant — and growing.
989,000
People living with dementia in the UK today3
1.4 million
Projected UK cases by 2040 — a 52% increase3
153 million
Projected global cases by 20504
>⅓
Of people with the condition are currently undiagnosed5
People with dementia can experience a range of symptoms, affecting memory, thinking, the ability to perform daily activities, and social abilities1,2
Earlier diagnosis means earlier access to the right care
Following an early diagnosis, people can begin health measures which may help to preserve existing cognitive function and start planning for the future7-11
Early diagnosis of AD may be key to preserving patient cognitive function and to help enable optimal disease management
Medical benefits
Begin health measures to preserve existing cognitive function to preserve daily activities.1
- Getting a diagnosis provides access to therapies, support groups, and medicines to manage symptoms and help you plan for the future.1
- Rule out other causes of cognitive decline.1
Emotional and societal benefits
A survey commissioned by the Alzheimer’s Society UK indicated that 89% of the participants would want to know the diagnosis if their symptoms were due to AD20.
- Enables families to future plan psychosocial care, and spend more time together.20
Cost benefits
Dementia care costs rise sharply as the condition progresses, from £28,700 annually per person for mild dementia to £80,500 for severe dementia.4
- Delayed disease progression extends the duration of earlier stages, reducing the financial burden.4
Biomarkers can detect Alzheimer's pathology before symptoms appear
Abnormal amyloid beta in plaques and tau in neurofibrillary tangles are the pathological hallmarks of Alzheimer's disease. Crucially, changes in both amyloid and tau biomarker proteins begin decades before the onset of symptoms — and can be detected via a blood or cerebrospinal fluid (CSF) biomarker test, or imaging.
Blood-based biomarkers (BBM)
Accessible, scalable testing that can be performed in primary care, enabling earlier triage and reducing pressure on specialist services.
Cerebrospinal fluid (CSF) biomarker tests
CSF analysis offering high concordance with amyloid PET imaging for confirmatory diagnosis in secondary care.
Roche’s AD testing portfolio includes two blood tests and two CSF ratios:
Elecsys pTau217 plasma
The first standalone, clinically validated, IVD-cleared blood test with a unified dual-cut-off designed to rule-in and rule-out amyloid pathology.21
Elecsys pTau181 plasma
A blood-based test with a 97.9% negative predictive value as a rule-out for amyloid pathology. 22
Elecsys pTau181/AB42 CSF ratio
A cerebrospinal fluid test that features 90% concordance with amyloid PET and is therefore able to detect amyloid pathology.23,24
Elecsys tTau/AB42 CSF ratio
A cerebrospinal fluid test that also features 90% concordance with amyloid PET and is therefore able to detect amyloid pathology.25
Unlocking the power of an early diagnosis and the potential of intervention for more patients
When it comes to Alzheimer’s, an early diagnosis is key to helping patients and their families make informed choices and plan for the future, and enabling clinicians to deliver personalised, patient-centric care.
It has been shown that higher intensity lifestyle interventions in individuals at high risk of cognitive decline and dementia had a statistically significant greater benefit on global cognition.15 Recently approved new therapies demonstrated to be most effective in slowing down cognitive decline and delaying AD progression, when implemented in early disease stages (i.e., MCI and mild dementia).13,14
Therefore, it is of utmost significance to educate patients on new technologies available for disease detection, potential management options and therapies, and for NHS services and healthcare providers to use these recent advances to guide diagnosis and patient management.
Helping address unmet needs in diagnosing Alzheimer’s disease
Elecsys pTau181 plasma11
A blood-based test intended as a rule-out test for amyloid pathology in primary care that features a 97.9% negative predictive value. While a negative test result is consistent with a negative amyloid PET, a positive result indicates that patients should be further investigated to determine whether the amyloid pathology can be a cause of cognitive impairment.
Elecsys pTau181/AB42 CSF ratio9
A cerebrospinal fluid test with a 90% concordance with amyloid PET scan that’s intended to assess patients' amyloid pathology status, either as an initial test, or following a triage rule/out test. A positive result is consistent with a positive amyloid PET scan result.
Elecsys tTau/AB42 CSF ratio10
A cerebrospinal fluid test with a 90% concordance with amyloid PET scan that’s intended to assess patients' amyloid pathology status, either as an initial test, or following a triage rule/out test. A positive result is consistent with a positive amyloid PET scan result.
Four reasons to bring Roche's BBM and CSF testing into your service
Increasing demand
New AD amyloid targeting therapies require early diagnosis and confirmation of amyloid pathology before initiation,16,17 reinforcing the value of these AD pathology specific assays for health systems and providers.
Reduces the patient burden for more invasive and costly testing options
By reducing reliance on more expensive testing (i.e., PET and CSF), AD blood tests may help to free up valuable testing resources and clinical expertise for use where they are needed most.
A faster path to diagnosis means help is within reach for more patients
Roche’s pTau181 blood test can be safely administered by a primary care doctor for the exclusion of AD pathology. Its use may therefore improve referral rates and facilitate early, timely diagnosis.
Accuracy
The Elecsys pTau181/Abeta42 and tTau/Abeta42 ratios and the Elecsys pTau181 plasma assay are traceable to reference materials to ensure accuracy of results.
Implementing tests in your laboratory
With over 450 fully-automated immunoassay analysers installed across the UK, Roche's AD assays are not only accessible but also scalable, giving patients broad access to high-quality testing in a timely manner.
CSF assays (Elecsys pTau181/AB42 and tTau/AB42 CSF ratios) are available across the full cobas® analyser portfolio pictured below.
Blood-based biomarker (BBM) testing with the Elecsys pTau181 plasma assay is available on the cobas® pure integrated solutions, cobas® pro integrated solutions, and cobas® 8000 modular analyser series (with e 801 module).
With an emerging menu of Research Use Only (RUO) biomarker assays, Roche is committed to advancing the science underpinning neurology diagnostics, with a growing portfolio of Research Use Only (RUO) biomarker assays
Roche’s current neurology RUO menu
View full tableRoche’s current neurology RUO menu
The following assays are available for research applications and are not intended for diagnostic use.
The following assays are available for research applications and are not intended for diagnostic use.
| 01 | 02 | 03 | ||
| AB42* Amyloid beta 42 |
GFAP* Glial fibrillary acidic protein |
YKL40* Chitinase 3-like 1 |
Additional assays available for research
View full tableAdditional assays available for research
| Neurology biomarkers | |
| Abeta40** | BD-Tau** |
| GDF-15** | IGFBP7** |
| Neurogranin** | NPTX2** |
| pTau217 (CSF)** | S100b** |
| SNAP 25** | sTREM-2** |
| tTau (plasma)** | |
These products are for Research Use Only and not for diagnostic procedures.
Alzheimer’s disease begins to form around 20 years before memory loss or other symptoms develop. However, in the absence of pathology-specific biomarkers, AD is not accurately diagnosed in symptomatic individuals, especially if they present with early symptomatic disease. According to the Alzheimer's Association, 85% of people would want to know early if they had the disease.18
An early and accurate diagnosis is crucial for patients, caregivers and physicians, as it can provide clarity and new treatment options.19,20
Clinical trials and other studies showed that up to 30% of individuals who meet the criteria for clinical Alzheimer’s dementia based on symptoms did not have Alzheimer’s-related brain changes.18 By utilising biomarkers to support Alzheimer’s diagnosis, especially in early disease stages, the accuracy of clinical diagnosis is expected to increase significantly.20 The need for a more precise diagnosis is now.
Definitions
What are biomarkers?
Biomarkers are biological changes that can be measured to indicate the presence or absence of a disease or the risk of developing a disease. The biomarkers most characteristic to Alzheimer’s are abnormal amyloid beta and tau proteins which accumulate in the brain and are present in the cerebrospinal fluid (CSF) and blood.
Therefore, changes in these proteins can be visualized by imaging the brain with scanning techniques, or can be measured in the CSF and blood2,20 using laboratory tests.
For example, the Elecsys CSF ratio assays are FDA cleared laboratory tests designed to detect the level of amyloid-beta protein (1-42) (Abeta42), phosphorylated tau protein 181 (pTau181) and total Tau protein (tTau). The results of these tests are intended to be interpreted by the physicians along with other clinical diagnostic evaluations to support AD diagnosis.20
What is cerebrospinal fluid?
CSF is a fluid that surrounds and protects the brain and spinal cord. CSF contains the abnormal amyloid and tau proteins associated with Alzheimer’s disease (AD). In case of cognitive issues and suspicion of AD, measuring the levels of these proteins from CSF helps with the AD diagnosis process. To collect CSF for testing these specific proteins, a lumbar puncture (spinal tap) is needed.2, 20
Early diagnosis of Alzheimer’s is key
Alzheimer's develops gradually, often beginning with subtle changes in the brain long before any symptoms appear, and then progresses to mild cognitive decline that can advance to demetia stages where it interferes with daily life, independence and function. The new amyloid targeting therapies and diagnostic tests have made possible the early detection of the biological changes that can lead to Alzheimer's and, in clinical context, early AD diagnosis and referal to therapy. As these therapies are effective in the early disease stages (i.e., MCI and mild dementia), early detection and diagnosis are crucial to timely intervention:18-21
Mild cognitive impairment due to Alzheimer’s
Mild symptoms but independence is maintained. Diagnosing people at the early, MCI stage, rather than the dementia stage, will allow healthcare professionals to intervene sooner — and at a stage that makes a great difference in people’s lives.
Preclinical AD
Evidence of Alzheimer's pathology, but no symptoms
MCI due to AD
Mild symptoms but independence is maintained
Mild AD dementia
Symptoms interfere with more complex activities and independence is no longer maintained
Moderate to severe AD dementia
Cognitive and functional symptoms interfere with many to most activities and lead to progressive loss of independence
Understanding signs of normal aging vs. Alzheimer’s disease
View full tableUnderstanding signs of normal aging vs. Alzheimer’s disease
AD affects memory, behavior, problem-solving and daily activities. It’s a medical condition — not part of normal aging — and one of the biggest public health challenges of our time. View the table below to compare normal signs of aging and Alzheimer’s.
AD affects memory, behavior, problem-solving and daily activities. It’s a medical condition — not part of normal aging — and one of the biggest public health challenges of our time. View the table below to compare normal signs of aging and Alzheimer’s.
Normal aging |
Alzheimer's |
| Occasionally making poor decisions | Frequently making poor decisions and having poor judgment |
| Occasional errors with managing finances | Trouble keeping track of bills and concentrating |
| Occasionally needing help with daily tasks | Difficulty completing daily tasks |
| Getting confused about what day of the week it is, but remembering it later | Confusion about place and time, including losing track of dates and sometimes forgetting where you are and how you got there |
| Having difficulty finding the right word once in awhile | Struggling with vocabulary, as well as trouble joining or following a conversation |
| Occasionally misplacing items, but having the ability to retrace steps and find them | Misplacing items, but losing the ability to retrace steps to find them |
| Lack of interest in social and familial obligations from time to time | Withdrawal from work, hobbies and social obligations |
| Irritability when a routine is disrupted | Changes in personality and mood, including getting easily upset |
| Changes with vision, which can be related to cataracts | Difficulty understanding visual images and spatial relationships |
| Forgetting appointment or names once in a while, but remembering them afterwards | Forgetting recently learned information and asking for the information repeatedly or relying on others for things previously handled on one's own |
Pat's Story: An Alzheimer's Diagnosis
Pat noticed changes in his memory and made the decision to seek answers early. Here he shares what that journey meant to him and his family.
Pat's Story: Choosing to seek answers
After noticing changes in his memory, Pat pursued a diagnosis rather than wait. He shares why getting clarity early made all the difference.
Read his story
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- WHO. Dementia Factsheet: key facts. 2023. Available from: https://www.who.int/news-room/fact-sheets/detail/dementia. Last accessed Jan 2025
- NIH. National Institute on Aging. What is dementia? symptoms, types, and diagnosis. 2022. Available from: https://www.nia.nih.gov/health/alzheimers-and-dementia/what-dementia-symptoms-types-and-diagnosis. Last accessed Jan 2025.
- How many people have dementia in the UK? (2024) Alzheimer’s Society. Available at: https://www.alzheimers.org.uk/blog/how-many-people-have-dementia-uk (Accessed: 02 December 2025).
- Nichols E, Vos T. The estimation of the global prevalence of dementia from 1990‐2019 and forecasted prevalence through 2050: An analysis for the global burden of disease (GBD) study 2019. Alzheimer’s & Dementia. 2021;17(S10)
- Lang L, et al. Prevalence and determinants of undetected dementia in the community: a systematic literature review and a meta-analysis. BMJ Open. 2017;7(2):e011146.
- GBD 2019 Dementia Forecasting Collaborators. Lancet Public Health 2022;7(2):e105–125;
- .Livingston G. al.The Lancet 2024; 404;10452, 572 - 628;
- Global CEO initiative on Alzheimer’s disease. Improving detection and diagnosis of Alzheimer’s disease and related dementias. Available from: https://www.usagainstalzheimers.org/sites/default/files/CEOi%20Perspectives%20-%20Detection%20and%20Diagnosis.pdf Last accessed July 2025
- Alzheimer Europe. European carers’ report. Carer’s experiences of diagnosis in five European countries. 2018. Available from: https://www.alzheimer-europe.org/sites/default/files/2021-11/04886%20Carers%27%20report_updated%20FINAL.pdf. Last accessed Jan 2025
- Carpenter BD, et al. J Am Geriatr Soc 2008;56(3):405–412; 5. FDA. Early AD: developing drugs for treatment, guidance for industry. 2024. Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM596728.pdf. Last accessed Jan 2025
- EMA Guidelines on the clinical investigation of medicines for the treatment of AD. 2018. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicines-treatment-alzheimers-disease-revision-2_en.pdf Last accessed July 2025.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269Orig1s001lbl.pdf Accesed October 2025
EMA Guidelines on the clinical investigation of medicines for the treatment of AD. 2018. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicines-treatment-alzheimers-disease-revision-2_en.pdf Last accessed July 2025.Baker LD, et al. JAMA 2025;334;(8):681-691. Structured vs Self-Guided Multidomain Lifestyle Interventions for Global Cognitive Function Available from:.https://jamanetwork.com/journals/jama/fullarticle/2837046. Last accessed May 2026
Cummings, J, et al. The Journal of Prevention of Alzheimer's Disease 2023;10(3):362-377. Available from: https://pubmed.ncbi.nlm.nih.gov/37357276/. Last accessed May 2026
Rabinovici, GD, et al. The Journal of Prevention of Alzheimer's Disease 2025; 12(3). Available from: https://www.sciencedirect.com/science/article/pii/S2274580725000949. Last accessed May 2026
- Alzheimer’s Association. 2024 Alzheimer’s Disease Facts and Figures. Alzheimer's Dement 2024;20(5).
- Alzheimer’s Association. Earlier Diagnosis. Available from:https://www.alz.org/alzheimers-dementia/research_progress/earlier-diagnosis. Accessed May 2026.
- Sabbagh MN, Lue LF, Fayard D, Shi J. Increasing Precision of Clinical Diagnosis of Alzheimer's Disease Using a Combined Algorithm Incorporating Clinical and Novel Biomarker Data. Neurol Ther. 2017 Jul;6(Suppl 1):83-95
- Elecsys® Method Sheets: ms_08846634501; ms_08821909501; ms_08846715501; ms_08846693501; ms_08821941501.
- Alzheimer's Research UK. Delivering Dementia Diagnosis: A blueprint for the future. 2025. Available from: https://www.alzheimersresearchuk.org/wp-content/uploads/2025/06/Delivering-Dementia-Diagnosis-A-Blueprint-for-the-Future.pdf. Last Accessed May 2026
- F. Hoffmann-La Roche Ltd. Elecsys pTau217 Method Sheet. (v1.0). 2026.
- Elecsys® phospho-Tau (181P) plasma method sheet 09697870500V1.0. Roche Diagnostics GmbH
- Elecsys® beta-Amyloid (1-42) CSF II Assay Method Sheet 08821941190V3.0. Roche Diagnostics GmbH
- Elecsys® Phospho-Tau (181P) CSF Assay Method Sheet 08846715190V3.0. Roche Diagnostics GmbH
- Elecsys® Total-Tau CSF Assay Method Sheet 08846685190V2.0. Roche Diagnostics GmbH