Neurology

Clarity for confident decisions in complex diagnostic pathways. 

Our Mission: Leading the way in brain health by driving innovative and accessible diagnostic solutions to improve patient outcomes.

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Preserve what makes people who they are

Our commitment

Creating a tomorrow where neurological disorders no longer limit human potential

Neurological disorders present one of the greatest challenges of the 21st century—complex, urgent and rising. At Roche, our hope is to create a tomorrow where neurological disorders no longer limit human potential—to preserve and restore what makes us who we are.

Our commitment goes beyond just a diagnosis. In order to preserve what makes people who they are, we are determined to make the invisible visible at every step of the disease path. Bringing testing of neurological disorders into the routine lab to support triaging, early diagnosis, confident monitoring as well as treatment choice, replacing uncertainty with clarity. 

We do this by prioritizing brain health, driving clarity and fostering collaboration to create a future where people with neurological disorders face each day with dignity and live healthier lives with renewed hope.

Biomarkers for clarity and confidence.
Neuro? Logically Roche. 

From Alzheimer’s disease (AD) to multiple sclerosis (MS) to traumatic brain injury (TBI), biomarkers deliver the rapid clarity and confidence crucial for early diagnosis and managing neurological disorders.

Alzheimer’s disease: The path to an Alzheimer’s diagnosis is long and complex, but the new blood-based Elecsys® pTau217 assay offers rapid clarity and confidence. Designed for simple "draw-and-go" testing across primary and secondary care, this robust standalone test aids early rule-in or rule-out of amyloid pathology in patients presenting with cognitive decline.1,2 By streamlining workflows and targeting cerebral spinal fluid (CSF) or positron emission tomography (PET) confirmation, Roche's diagnostic solution helps unlock timely diagnosis and early treatment—giving patients and families time, clarity, and hope.1-4

Multiple sclerosis: Because irreversible neurological injury often accumulates subclinically, detecting disease activity beyond what magnetic resonance imaging (MRI) reveals is crucial.5 The minimally invasive, accessible Elecsys® NfL (neurofilament light chain) assay seamlessly integrates into routine practice to frequently monitor subclinical neuroinflammation between scheduled imaging.5-7 By utilizing age-adjusted percentiles (ages 18–65) compared against a healthy reference group, it distinguishes true disease activity from natural aging to prevent misclassification.6,8 Traceable to the National Institute of Standards and Technology (NIST) standards for reliable cross-lab performance, this diagnostic solution empowers timely therapy adjustments and personalized care—ensuring no change in multiple sclerosis progression goes unnoticed.6

Traumatic brain injury: Because traumatic brain injury (TBI) often remains underdiagnosed in mild and moderate cases with subtle symptoms, rapid diagnostic clarity is critical. The Elecsys® S100 assay provides a fast, reliable measure of brain injury to identify patients at low risk for intracranial lesions.9-11 Supported by over 15 years of clinical evidence and recommended by international guidelines, this blood test helps safely reduce unnecessary cranial computed tomography (CT) scans and radiation exposure.12-15 By optimizing emergency department (ED) resource use and shortening stays, Roche’s TBI diagnostic solution deliver what patients and families need most: timely care, reduced risk, and peace of mind.

Elecsys® neurological test cassettes in the lab with an automated analyzer in the background
Disease burden

A growing global burden

Neurology is an extremely complex disease area with over 400 neurological disorders.16 Today around 43% of the world's population is affected—that's 3.4 billion individuals.17 The global impact of neurological disorders continues to grow in prevalence and is expected to double by 2050, presenting a significant burden on society and healthcare systems.18

Neurological conditions are now the leading cause of ill health and disability worldwide, responsible for 443 million years of healthy life lost due to illness, disability, and premature death with an increase of 18% since 1990.17,19

Neurological diseases can strike people and their families at any stage of life. And the  total cost of neurological disorders is vast and expected to rise, placing a huge burden on already stretched healthcare systems. For example in the EU and the US, the current total cost of neurological disorders is comparable to that of cancer, cardiovascular disease and diabetes combined. In addition about two-thirds of the economic burden of neurological disorders is beyond health system costs and largely unknown from lost productivity, caregiving and medication costs.20,21 This trend is set to grow due to aging populations and consequent increase of disability.

Diagnostic challenges and impact

The journey to find answers is often long and complex

The complexity of neurological symptoms coupled with a lack of clear criteria make missed or late diagnosis common. 

Neurology is an extremely complex disease area with over 400 neurological disorders.16 Overlapping symptoms make diagnosis slow and difficult.22,23 67% of patients with a neurological condition were initially misdiagnosed, with misdiagnosis linked to 56% of patients having difficulty describing symptoms.24  People with the same symptoms are getting different diagnoses across regions due to a lack of standardized criteria.22,23

Specialist and secondary care services are overwhelmed, a problem that is likely to grow. 

There is a global shortage of trained neurologists and specialized healthcare professionals, with as few as one neurologist per million people in some of the lowest-income regions.25 Shortages are unlikely to improve, as WHO estimates a projected shortfall of 11 million health workers by 2030.26

Despite the significant social and economic consequences, only 12% of countries in the WHO’s Neurology Atlas 2017 reported a separate public health system budget for neurological disorders, leaving patients with a lack of appropriate assessment, diagnosis, treatment and support through the patient journey.27

Missed or late diagnosis, delayed treatment and stigma can have significant consequences on a person's health and well-being. 

This is a challenging time for the people affected, families, doctors and healthcare systems alike. One in seven patients with neurological conditions feel affected by stigma (84%).24 In addition, symptoms of Alzheimer’s are often mistaken as a normal part of aging, while fear, stigma and low public awareness can discourage people from seeking help.28 Early detection with access to timely and accurate diagnosis and ongoing monitoring is critical to provide the best care for people with neurological disorders.

Biomarkers offer an objective assessment of neurological disease activity and progression with high efficacy and at low cost. 

Advances in biomarker technologies are revolutionizing early detection, making the invisible visible in a cost-effective way. Blood-based biomarkers, in particular, provide a comfortable and accessible option for patients.

Innovative technologies are transforming the quality, reliability and utility of diagnostic testing, enabling informed decisions and timely therapy adjustments—freeing up valuable healthcare resources and helping to keep people and society healthier for longer.

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Benefits of Roche diagnostic and management solutions for neurology

Prioritizing brain health

Acknowledging the growing importance of brain health

Changing the perception of how neurological disorders are perceived, diagnosed and monitored.

  • Shaping neuroscience discovery: Serving as one of the largest providers of collective data intelligence.29
  • Turning data into action: Co-founding the Brain Health Initiative to measure the economic impact of brain disorders, enabling evidence-based dialogues with policymakers to inspire meaningful policy changes.30
  • Accelerating medical innovation adoption: Leveraging the expertise of more than 300 global consultants in care pathway implementation and optimisation to accelerate patient access to high-value neurology solutions. 
Driving clarity

Advanced diagnostic solutions providing clarity and confidence

Helping clinicians make better-informed decisions and improve patient outcomes across the disease pathway.

  • Comprehensive portfolio: Roche offers one of today's widest and growing IVD-approved assay portfolio in neurology, covering a broad spectrum of disorders across the patient pathway.31 Our portfolio includes reliable, clinically proven biomarkers for AD, including both established CSF and innovative blood-based biomarkers such as pTau217 and pTau181, as well as specialized assays for MS and TBI.1,6,32-38
  • Powerful combination: By pairing cutting-edge neurological biomarkers with established analytical  instruments, reagents, and validation methods, we bring actionable clinical insights straight to your existing workflow. This allows new neurological tests to integrate seamlessly into established laboratory setups, advancing diagnostics without operational disruption. 
  • Exceptional global presence 150+ countries:38 With a footprint spanning more than 150 countries, we enable accessible routine testing in neurology worldwide. Our highly scalable systems ensure your laboratory is fully prepared to manage the rapidly growing demand for neurological diagnostics efficiently and reliably.

 

Fostering collaboration

Collaboration is the core of our approach to solve the complexities of neurological disorders

Enabling the discovery of novel biomarkers to inspire hope for the future.

  • 3-step structured approach: Guiding innovation from early discovery—powered by the Neuro Toolkit, a unique collaborative research ecosystem—through commercially available Research Use Only (RUO) assays, to fully approved IVD biomarkers.
  • Pharma collaboration: Validating early-development neuro biomarkers in clinical trials alongside our pharma partners to establish high-impact, routine laboratory tests. 
  • Advancing scientific understanding: Investing in the future of neurological healthcare through collaboration with global partners, including leading academic institutions, patient advocacy groups, and technology innovators.
A clinician in a lab coat stands and faces a physician to discuss the neurology diagnostic testing panel available

Neurology portfolio overview for clinicians

Discover our wide and growing IVD-approved assay portfolio in neurology, covering a broad spectrum of neurological disorders across the care path.

 

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References:

  1. F. Hoffmann-La Roche Ltd. Elecsys pTau217 Plasma. Method Sheet. (v1.0). 2026.
  2. Brum WS, et al. A two-step workflow based on plasma p-tau217 to screen for amyloid β positivity with further confirmatory testing only in uncertain cases. Nat Aging. 2023;3:1079–90.
  3. Li Y, et al. Cost-effectiveness analysis of blood-based biomarker testing in the diagnosis of Alzheimer's disease pathology. J Prev Alzheimers Dis. 2026;13:100474.
  4. Mattke S, et al. Estimation of the value-based price of a blood test for Alzheimer's disease pathology in primary and specialty care in the U.S. J Prev Alzheimers Dis. 2025;12:100219.
  5. Freedman MS, et al. Guidance for use of neurofilament light chain as a cerebrospinal fluid and blood biomarker in multiple sclerosis management. EBioMedicine. 2024;101:104970. 
  6. F. Hoffmann-La Roche Ltd. Elecsys NfL. Method sheet. (v2.0). 2026.
  7. Thebault S, et al. High or increasing serum NfL is predictive of impending multiple sclerosis relapses. Mult Scler Relat Disord. 2022;59:103535. 
  8. Benkert P, et al. Serum neurofilament light chain for individual prognostication of disease activity in people with multiple sclerosis: a retrospective modelling and validation study. Lancet Neurol. 2022;21:246–57.
  9. Korfias S, et al. Serum S-100B protein as a biochemical marker of brain injury: a review of current concepts. Curr Med Chem. 2006;13:3719–31. 
  10. Thelin E, et al. Utility of neuron-specific enolase in traumatic brain injury; relations to S100B levels, outcome, and extracranial injury severity. BMC Med. 2016;14:6. 
  11. F. Hoffmann-La Roche Ltd. Elecsys S100. Method sheet. (v3.0) 2024.
  12. Undén J and Romner B. Can low serum levels of S100B predict normal CT findings after minor head injury in adults?: an evidence-based review and meta-analysis. J Head Trauma Rehabil. 2010;25:228–40. 
  13. Faisal M, et al. Diagnostic performance of biomarker S100B and guideline adherence in routine care of mild head trauma. Scand J Trauma Resusc Emerg Med. 2023;31:3. 
  14. Société Française de Médecine d'Urgence. Recommandations de pratiques professionnelles: traumatisme crânien léger (RPP-TCL) [Internet; cited 2026 July 27]. Available from: https://www.sfmu.org/upload/consensus/RPP-TCL-2022.pdf. 
  15. ACS Trauma Programs. Best Practices Guidelines: The Management of Traumatic Brain Injury [Internet; cited 2026 July 27]. Available from: https://www.facs.org/media/vgfgjpfk/best-practices-guidelines-traumatic-brain-injury.pdf. 
  16. OneNeurology. Integrating neurological disorders and brain health into global NCD agendas [Internet; cited 2026 Sep 16]. Available from: https://oneneurology.net/integrating-neurological-disorders-and-brain-health-into-global-ncd-agendas/
  17. IHME. The Lancet Neurology: Neurological conditions now leading cause of ill health and disability globally, affecting 3.4 billion people worldwide [Internet; cited 2026 Jul 27]. Available from: https://www.healthdata.org/news-events/newsroom/news-releases/lancet-neurology-neurological-conditions-now-leading-cause-ill.
  18. World Federation of Neurology. Number of people living with brain disease expected to double by 2050 [Internet; cited 2026 Jul 27]. Available from: https://wfneurology.org/activities/news-events/archived-news/2023-10-16-wcn.
  19. World Health Organization. Over 1 in 3 people affected by neurological conditions, the leading cause of illness and disability worldwide [Internet; cited 2026 Jul 27]. Available from: https://www.who.int/news/item/14-03-2024-over-1-in-3-people-affected-by-neurological-conditions--the-leading-cause-of-illness-and-disability-worldwide.
  20. Olesen J, et al. The economic cost of brain disorders in Europe. Eur J Neurol. 2012;19:155-62.
  21. Gooch CL, et al. The burden of neurological disease in the United States: A summary report and call to action. Ann Neurol. 2017;81:479–84.
  22. Fornari A, et al. Inequities in neurological care: Access to services, care gaps, and other barriers—A systematic review. Neurology. 2022;98:123–31.
  23. Zaman MS, et al. Barriers to accessing healthcare services for people with Parkinson’s disease: A scoping review. Parkinsons Dis. 2023;2023:1–10.
  24. EFNA. Annual Report 2024 [Internet; cited 2026 Jul 27]. Available from: https://www.efna.net/wp-content/uploads/2025/04/Annual-Report-2024_web.pdf.
  25. Bassetti CL, et al. General neurology: Current challenges and future implications. Nat Rev Neurol. 2021;17:653–64.
  26. World Health Organization. Health workforce [Internet; cited 2026 Jul 27]. Available from: https://www.who.int/health-topics/health-workforce/.
  27. World Health Organization. Atlas of Neurology [Internet; cited 2026 Jul 27]. Available from: https://www.who.int/publications/i/item/atlas-country-resources-for-neurological-disorders.
  28. University College London. Dementia takes 3.5 years to diagnose after symptoms begin [Internet; cited 2026 Jul 27]. Available from: https://www.ucl.ac.uk/news/2025/jul/dementia-takes-35-years-diagnose-after-symptoms-begin?gridset=show.
  29. F. Hoffmann-La Roche Ltd. Data on file.
  30. IHME. Brain Health Atlas [Internet; cited 2026 Jul 27]. Available from: https://brainhealthatlas.org/about#bh.
  31. F. Hoffmann-La Roche Ltd. Data on file.
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  33. F. Hoffmann-La Roche Ltd. Elecsys Apolipoprotein E4 Plasma. Package insert. (v1.0). 2025.
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  38. F. Hoffmann-La Roche Ltd. Data on file.