Alzheimer's disease: For healthcare professionals

Advanced blood-based and CSF biomarker solutions provide clarity for a comprehensive AD fluid biomarker solution to aid clinical diagnosis

Don't wait to confirm amyloid positivity and unlock new therapies for more patients.

CSF biomarkers provide a cost-effective and accessible alternative to a PET scan

CSF biomarkers are highly concordant with established gold standards like Amyloid PET scans and remain critical for confirming Alzheimer’s disease.3 Confirming amyloid pathology with CSF is a recommended approach and CSF testing capacity can be essential to meeting rising diagnostic demand and addressing the gap in PET availability.4

Elecsys pTau181/AB42 CSF ratio5 and Elecsys tTau/AB42 CSF ratio6
A cerebrospinal fluid tests 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 blood test in some patients as clinically indicated. A positive result is consistent with a positive amyloid PET scan result.

Blood-based testing opens the door for primary care to play a role in AD testing

Roche’s Elecsys® blood-based biomarker (BBBM) portfolio, including pTau181 and pTau217 has the potential to transform Alzheimer’s testing by offering scalable, cost-effective, timely and accessible testing options.

Elecsys® pTau217 plasma1 
Healthcare providers across primary and specialty care now have access to the first and only FDA-cleared, single-biomarker blood test designed to support both rule-in and rule-out assessment of amyloid pathology. The assay is intended for use as an aid in identifying amyloid pathology associated with Alzheimer’s disease in individuals 55 years and older with signs, symptoms or complaints of cognitive decline. The result should be interpreted in conjunction with other clinical information.

By providing a minimally invasive blood-based option, Elecsys® pTau217 may help clinicians assess the likelihood of amyloid pathology earlier in the disease, streamline diagnostic pathways, identify appropriate next steps and make more efficient use of limited specialist resources. Therefore, the test can aid early diagnosis and can identify patients with mild cognitive impairment at the optimal therapeutic window, where, for example, amyloid targeting therapies are most effective.

Elecsys pTau181 plasma2 
A blood-based test intended as an aid in the initial assessment for Alzheimer’s disease and other causes of cognitive decline in adult patients aged 55 years and older, presenting with signs, symptoms, or complaints of cognitive decline. The result should be interpreted in conjunction with other clinical information.

The Elecsys® pTau181 is 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. 

Transforming Alzheimer's evaluations

Elecsys® pTau217 can be used across primary and specialty care, helping bring blood-based Alzheimer’s biomarker assessment closer to the primary clinical setting where patients often first present with cognitive concerns, creating a more systematic workflow as patients move through the diagnostic pathway. The test supports continuity of care by employing the same validated clinical cutoffs across primary and specialty care settings.

The Elecsys® pTau217 can:1

Enable early-disease-stage assessment of patients with cognitive complaints by providing information that may help clinicians rule out or rule in amyloid pathology and refer for further testing as clinically indicated.

 

Aid early diagnosis and identify patients with mild cognitive impairment at the optimal therapeutic window, i.e., where amyloid targeting therapies are most effective.

Broadening access to Alzheimer’s testing

The use of blood-based biomarkers may: 

  • Better integrate primary care into the Alzheimer’s diagnosis pathway and expand testing availability

  • Improve referral quality by guiding physicians’ decisions on patient referrals

  • Help preserve neurologists’ resources for patients with the greatest need

  • Potentially reduce the use of more invasive and costly procedures such as positron emission tomography (PET) and cerebrospinal fluid (CSF) testing, thus improving efficiency and cost-effectiveness across the healthcare system

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

Alzheimers disease primary and specialty care chart

Biomarkers in blood and CSF can be measured in early stages of AD progression

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 blood using laboratory tests.7,8

Alzheimers disease levels of bbbms chart

Featured products

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. Elecsys Phospho-Tau 217P Plasma Method Sheet
  2. Elecsys Phospho-Tau 181P PLasma Method Sheet
  3. Dickerson BC, Atri A, Clevenger C, et al. The Alzheimer's Association clinical practice guideline for the Diagnostic Evaluation, Testing, Counseling, and Disclosure of Suspected Alzheimer's Disease and Related Disorders (DETeCD-ADRD): Executive summary of recommendations for specialty care. Alzheimer's Dement. 2025; 21:e14337. https://doi.org/10.1002/alz.14337
  4. Cummings, J., Apostolova, L., Rabinovici, G.D. et al. Lecanemab: Appropriate Use Recommendations. J Prev Alzheimers Dis (2023)
  5. Elecsys® pTau181/AB42 CSF ratio Method Sheet
  6. Elecsys® tTau/AB42 CSF ratio Method Sheet
  7. Jack CR Jr, et al. Tracking pathophysiological processes in Alzheimer's disease: an updated hypothetical model of dynamic biomarkers. Lancet Neurol. 2023; 12(2): 207–216. doi:10.1016/S1474-4422(12)70291-0
  8. Bloom GS. Amyloid-β and Tau: The Trigger and Bullet in Alzheimer Disease Pathogenesis. JAMA Neurol. 2014;71(4):505–508. doi:10.1001/jamaneurol.2013.5847