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Alzheimer’s disease testing

Advanced biomarker technology for Alzheimer's disease testing and diagnosis offers a brighter future for patients and their loved ones.

Models depicting a woman supporting her husband who is suffering from dementia in a living room

Innovative diagnostics accelerating early detection of Alzheimer’s

Advancing Alzheimer’s testing and diagnosis

Dementia is a devastating disease. It destroys the core of a patient's personality, eventually leading to death. Alzheimer's disease (AD) is the most common form of dementia, accounting for 60-70% of all cases.1 In addition to the profound impact on patients and their loved ones, Alzheimer's poses a significant economic burden on healthcare systems.2

Roche Diagnostics has developed an extensive portfolio of technologies designed to detect, diagnose, and monitor Alzheimer's disease effectively.3

With our passion and investment in research and development, we have been helping clinicians for over 50 years to find answers in the complex area of neurology. Our Elecsys® IVD cerebrospinal fluid (CSF) biomarker assays aid in confirmatory testing for Alzheimer's diagnosis. The Elecsys® Amyloid Plasma Panel of blood-based biomarker tests aids in ruling out Alzheimer’s, and our neurofilament light (NfL) assay has potential to accelerate neurodegenerative disease detection.

An escalating global health challenge

Alzheimer’s is a progressive, fatal brain disease that gradually destroys memory, thinking skills, and problem-solving abilities. It impairs daily functioning, making it challenging for patients, their loved ones, and caregivers. Over 55 million people globally are living with dementia, with 10 million more diagnosed each year. As populations age, the impact of Alzheimer’s is expected to intensify, with prevalence projected to be over 150 million people globally by 2050.5

Furthermore, as much as two-thirds of patients with dementia remain undiagnosed, with some patients waiting up to 32 months for a formal diagnosis.6-10 It is estimated that up to 35% of AD cases could be prevented or delayed by modifying risk factors.9 Early and accurate diagnosis allows patients and their caregivers to begin health measures to preserve their quality of life for longer and plan for the future.10

Alzheimer’s also poses a significant economic burden to healthcare systems. In 2020, the global annual cost of AD was estimated to be more than USD $800 billion.11 In the US alone, the annual cost to healthcare systems is estimated to triple over the next decades, reaching $1.1 trillion by 2050.12 Early Alzheimer’s diagnosis helps save money on medical and care costs.13

Navigating the uncertainty of Alzheimer’s diagnostics

Alzheimer’s disease is difficult to diagnose because its symptoms often resemble those of regular aging. Biological changes are believed to start decades before clinical symptoms of Alzheimer’s disease become evident.14,15 At Roche Diagnostics, we focus on solutions that accelerate the detection of neurodegenerative diseases.

Before the development of diagnostic technology, Alzheimer’s disease could only be diagnosed post-mortem. Now, biomarker testing is recommended for diagnosis due to its accuracy, providing physicians with confidence.16 Historically, certain imaging and cerebrospinal fluid (CSF) biomarkers have been measured through manual enzyme-linked immunosorbent assays (ELISA) techniques, which produce less precise and reliable results, as well as much longer turnaround times. Roche has developed automated platforms for the routine implementation of CSF biomarkers for improved precision and reduced turnaround times.17,18

With the scientific knowledge, scale, and power to develop standardized solutions, we aim to provide global solutions for Alzheimer’s testing to help clinicians navigate the complex area of neurology and give patients the answers they desperately need.

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Benefits of Roche diagnostic solutions for managing Alzheimer’s Disease

Accurate results for all lab sizes 19

  • High accuracy and precision: Elecsys® assays achieve highly accurate and precise results across all cobas® e platforms, with their precision confirmed in the Alzheimer's Association Quality Control (AAQC) program19,20
  • Reliable: Roche Elecsys® assays have been standardized and are traceable to reference materials and reference methods
  • Fast results: Elecsys® assays allow targeted quantification of Alzheimer’s disease parameters in only 18 minutes.
  • Automated integration: All Alzheimer’s disease Elecsys® assays can run on all cobas® instruments, enabling labs to choose an instrument that meets their size and throughput requirements.

Broader access to Alzheimer’s testing

The use of CSF biomarkers may improve accessibility by offering a more affordable alternative to amyloid-PET scans.21 Roche Elecsys® Alzheimer’s assays are available on all cobas® instruments, with the ability to analyze multiple biomarkers for Alzheimer’s disease from a single sample, saving time and resources. 

Improved access supports clinicians in making informed and timely treatment decisions, so the people who need it most get the treatment they need.

Improving outcomes in Alzheimer’s care

Roche is in rigorous pursuit of scientific advancements to unlock our understanding of neurological disorders and help transform and enhance patient quality of life.

Our efforts focus on driving disease awareness, so people recognize the early signs of Alzheimer’s disease and understand the importance of getting tested, thereby enabling patients and their families to make informed decisions about care.

By creating global solutions, Roche is helping to make Alzheimer’s disease more accessible. Together, we drive better public health outcomes, become better prepared for rapid responsiveness with improved healthcare infrastructure, and help in the global fight against neurodegenerative disorders.

Contact us

Do you have questions about our products or services? We’re here to help. Contact a Roche representative in your region.

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References

  1. World Health Organization.Dementia. [Internet; updated 2023 Mar; cited 2024 Aug 5]. https://www.who.int/news-room/fact-sheets/detail/dementia
  2. Alzheimer’s Association. Alzheimer’s Disease Facts and Figures. Alzheimers Dement 2024;20(5).
  3. Schindler SE, et al. Alzheimer's Dement. 2018;14:1460–9.
  4. Jahn H. Memory loss in Alzheimer's disease. Dialogues Clin Neurosci. 2013;15(4):445-54.
  5. 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).
  6. 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.
  7. Löppönen M, et al. Diagnosing cognitive impairment and dementia in primary health care -- a more active approach is needed. Age Ageing. 2003;32:606–612. 
  8. Boustani M, et al. Screening for dementia in primary care: a summary of the evidence for the U.S. Preventive Services Task Force.  Ann Intern Med. 2003;138:927–937.
  9. Valcour VG, et al. The detection of dementia in the primary care setting. Arch Intern Med. 2000;160:2964–2968.
  10. Prince MJ, et al. World Alzheimer’s Report 2011. Alzheimer’s Disease International. 2011.
  11. Montero-Odasso M, et al. One third of dementia cases can be prevented within the next 25 years by tackling risk factors. The case "for" and "against". Alzheimers Res Ther. 2020;12(1):81.
  12. Porsteinsson AP, et al. Diagnosis of Early Alzheimer's Disease: Clinical Practice in 2021. J Prev Alzheimers Dis. 2021;8(3):371-386.
  13. Barnett, J.H., Lewis, L., Blackwell, A.D. et al. Early intervention in Alzheimer’s disease: a health economic study of the effects of diagnostic timing. BMC Neurol 14, 101 (2014).
  14. Masters CL, et al. Alzheimer's disease. Nat Rev Dis Primers. 2015;1:15056.
  15. Blennow K, et al. Lancet. Alzheimer's disease. Lancet. 2006;368:387-403.
  16. Sabbagh MN, et al. Increasing Precision of Clinical Diagnosis of Alzheimer's Disease Using a Combined Algorithm Incorporating Clinical and Novel Biomarker Data. Neurol Ther. 2017;6(Suppl 1):83-95.
  17. Bellomo G, et al. Measurement of CSF core Alzheimer disease biomarkers for routine clinical diagnosis: do fresh vs frozen samples differ? Alzheimers Res Ther. 2020;12(1):121.
  18. Bittner T, et al. Technical performance of a novel, fully automated electrochemiluminescence immunoassay for the quantitation of beta-amyloid (1-42) in human cerebrospinal fluid. Alzheimers Dement. 2026;12(5):517-526.
  19. Elecsys® Method Sheet: ms_08821941500V1.0, ms_08821909500V1.0, ms_08846715500V1.0, ms_08846693500V1.0,  ms_08846634500V1.0, ms_08846685500V1.0
  20. University of Gothenburg. The Alzheimer’s Association QC program for CSF and blood biomarkers. [internet cited 2024 Dec 1]. https://www.gu.se/en/neuroscience-physiology/the-alzheimers-association-qc-program-for-csf-and-blood-biomarkers.
  21. Contador J, et al. Eur Arch Psychiatry Clin Neurosci. 2023;273(1):243-252.