Elecsys® Phospho-Tau (181P) Plasma

IVD For in vitro diagnostic use.
Elecsys<sup>®</sup>&nbsp;Phospho-Tau (181P) Plasma
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Our first Roche Blood Based Biomarker dedicated to stratifying patients evaluated for Alzheimer's Disease: Elecsys® Phospho-Tau (181P) Plasma

Early and accurate diagnosis of Alzheimer's disease (AD) remains a significant global challenge. Up to 75% of individuals experiencing symptoms are not diagnosed, and those who do receive a diagnosis often face a delay of nearly three years on average after symptom onset.1 The identification of amyloid pathology is crucial for an accurate AD diagnosis and for guiding appropriate treatment.

Elecsys® pTau181 Plasma is the first In Vitro Diagnostic Regulation (IVDR) certified test to rule out Alzheimer’s associated amyloid pathology. The minimally invasive, blood-based test can serve as a rule out for Alzheimer’s pathology, reducing the need for confirmatory testing with a negative result.

Traditional methods for confirming amyloid pathology, such as positron emission tomography (PET) scans and cerebrospinal fluid (CSF) assessments, can be expensive, difficult to access, and invasive. The Elecsys® pTau181 Plasma assay is set to revolutionize this landscape by providing a minimally invasive, blood-based solution.

A streamlined approach to diagnosis and care

With a negative Elecsys® pTau181 Plasma blood test, individuals can potentially avoid further unnecessary and invasive investigations for Alzheimer's using CSF or PET, allowing them to identify the care pathway that is right for them. This assay offers a single cut-off to rule out AD and guide further clinical investigation, making it a valuable tool for healthcare professionals.

Designed to support general neurologists and primary care physicians, the Elecsys® pTau181 Plasma assay requires no specialized expertise, facilitating broader access to early assessment. Furthermore, the assay's performance has been validated in "real-world-like" populations, demonstrating its utility worldwide in diverse patient groups presenting with cognitive complaints.2

The Elecsys® pTau181 Plasma assay is set to help streamline the diagnostic process, reduce diagnostic delays, and ultimately improve outcomes for individuals experiencing cognitive symptoms.

The introduction of blood-based biomarkers like pTau181 marks a significant step forward in addressing the challenges of the current Alzheimer's Disease diagnostic pathway. This innovation aims to create a more efficient and accessible journey for patients.

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Benefits at a glance

Benefits at a glance

A simple blood test overcomes geographical and logistical barriers associated with more invasive or specialized diagnostic methods, making early assessment more widely available.3,4

While not a definitive diagnostic tool on its own, Elecsys® pTau181 Plasma provides an early indication of likelihood that a patient does not have underlying AD pathology. This information helps clinicians make more informed decisions about which patients should proceed with further, more definitive evaluations, potentially years before advanced symptoms appear.2,5,6

Elecsys® pTau181 Plasma can help guide patients more effectively. It can assist in identifying individuals who may not have AD-related amyloid pathology, allowing them to be referred to the most appropriate care for their cognitive symptoms, while prioritizing those with a higher likelihood of AD for further, targeted evaluation.3,7

By acting as an initial triage tool, Elecsys® pTau181 Plasma can help optimize the use of more complex and costly confirmatory tests, reducing the overall diagnostic burden on patients and healthcare systems.3,7

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Elecsys® Phospho-Tau (181P) Plasma specifications

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Elecsys® Phospho-Tau (181P) Plasma specifications

Product specification 

Value

Systems

cobas® e 402 analytical unit, cobas® e 801 analytical unit

Testing time

18 minutes

Sample material

K2 EDTA and K3 EDTA plasma. EDTA Plasma tubes containing separating gel can be used

Sample volume

30 μL

Testing principle

2-steps sandwich assay

Onboard stability

16 weeks

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      Roche's Elecsys® pTau181 Plasma test, which measures phosphorylated Tau (pTau) 181 protein to help indicate Alzheimer's disease, has received CE Mark.

      Learn how Roche tackles Alzheimer's through innovation and collaboration, developing diagnostics and treatments to act early and help patients retain independence.
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        References

        1. Alzheimer’s Disease International. World Alzheimer Report 2022 [Internet; cited April 2025]. Available from: https://www.alzint.org/resource/world-alzheimer-report-2022/.
        2. Kirste I et al. Revamping Alzheimer's disease diagnostics: evaluating future IVD plasma p-Tau 181 and ApoE4 immunoassays for amyloid detection in a multi-centre study reflective of routine clinical practice. Presented at: 17th CTAD Conference; 2024, Oct 29 - Nov 01; Madrid, Spain. Abstract# LP065.
        3. Mattke S et al. Blood‐based biomarkers for Alzheimer's pathology and the diagnostic process for a disease‐modifying treatment: Projecting the impact on the cost and wait times. Alzheimers Dement (Amst). 2020;12(1):e12081.
        4. Angioni D et al. Blood Biomarkers from Research Use to Clinical Practice: What Must Be Done? A Report from the EU/US CTAD Task Force. Journal of Prevention of Alzheimer's Disease. 2022;9(4):569-579.
        5. Karikari TK et al. Plasma phosphorylated tau 181 as a biomarker for Alzheimer's disease: a diagnostic performance and prediction modelling study using data from four prospective cohorts. The Lancet Neurology. 2020;19(11):942-954..
        6. Moscoso A et al. Time course of phosphorylated-tau181 in blood across the Alzheimer's disease spectrum. Brain. 2021;144(1):325-337.
        7. Mielke MM et al. Recommendations for clinical implementation of blood-based biomarkers for Alzheimer's disease. Alzheimers Dement. 2024;20(11):8216-8224.