Roche has announced that it has received CE Mark for its Elecsys pTau181 test to measure phosphorylated Tau (pTau) 181 protein which is an indicator of amyloid pathology, a hallmark of Alzheimer’s disease.
The test, which has been developed in collaboration with Eli Lilly and Company, can be used by clinicians in conjunction with other clinical information to rule out Alzheimer’s disease as the cause of cognitive decline. This could avoid the need for further confirmatory investigation for patients testing negative.
“The burden of Alzheimer’s disease on society and healthcare systems is increasing as the world’s population ages,” said Matt Sause, CEO of Roche Diagnostics. “With Elecsys pTau181, doctors can give patients and their caregivers the clarity they need when establishing the cause of cognitive decline. By enabling an earlier and less invasive diagnosis, this test has the potential to improve patient outcomes and decrease costs for healthcare systems worldwide.”
Ashton Harper, Global Medical Affairs Lead for Neurosciences, Roche Diagnostics, added: "The launch of Elecsys pTau181, the first IVDR-certified blood test designed to rule out amyloid pathology, marks a significant advancement in Alzheimer’s disease diagnostics. This test allows clinicians to confidently determine the absence of amyloid pathology - a key hallmark of Alzheimer’s disease - in individuals who lack this biomarker in their blood. By ruling out Alzheimer’s disease at an earlier stage, clinicians can not only reduce the need for unnecessary additional testing but also allocate resources to prioritise patients who require comprehensive evaluation, enabling them to receive a definitive diagnosis more quickly.
“Early in 2024, this blood-based biomarker test was accepted onto the Government’s Innovative Devices Access Pathway (IDAP) pilot programme. The IDAP programme is an innovative initiative aimed at accelerating both the regulation and adoption of cutting-edge technologies within the NHS, ensuring broad and equitable access for all individuals who could benefit from them.
“In the coming months, we expect to launch a range of Alzheimer’s blood tests, which will significantly expand diagnostic capabilities for patients at much earlier stages of this devastating disease. This progress ushers in a future of accessible, early, and precise clinical diagnoses of Alzheimer’s disease - both the ruling in and ruling out of the disease - across the UK to help positively shape the future for patients and their families.”
Barriers to early and accurate diagnosis of Alzheimer’s disease exist across the world. Up to 75% of people living with symptoms are not diagnosed, and those who have received a diagnosis waited nearly three years on average after symptom onset.1 The identification of amyloid pathology is critical for Alzheimer’s diagnosis and treatment. Current methods to confirm amyloid pathology - including positron emission tomography (PET) and cerebrospinal fluid (CSF) assessment - can be expensive, difficult to access and invasive. With a negative Elecsys pTau181 blood test, people can avoid further unnecessary investigations for Alzheimer’s using CSF or PET and can identify the care pathway that is right for them.
Clinical study results support that the test can be implemented effectively across care settings, including primary care, where most patients first seek help for cognitive concerns. Those with positive results are then able to undergo further testing, supporting earlier identification of Alzheimer’s pathology. This is key to accessing new treatments that are most effective when used early in the disease progression, enabling patients to make informed decisions about their future care.
Clinical data
The CE Mark for the Elecsys pTau181 blood test was based on data from a prospective, multicentre study, which included 787 patients across the US, Europe and Australia. The study showed the test was able to rule out Alzheimer’s disease with a high negative predictive value (NPV) of 93.8% based on a 22.5% prevalence of amyloid positivity according to positron emission tomography (PET) scans, with 83.6% sensitivity. The rule out performance of the test was only minimally impacted by the patients’ age, gender, body mass index or impaired kidney function.
This global, prospectively-collected, diagnostic registrational clinical study was the first of its kind in the industry to investigate the test’s clinical performance in a diverse patient population, aged 55-80 years old that reflects as closely as possible the patients who could benefit from the test. It involved a subset of patients from a wider study looking at a highly diverse set of patients with broad inclusion criteria, to ensure the test could be used effectively across different geographies and ethnicities.
Elecsys pTau217 blood test
Roche is also developing the Elecsys pTau217 blood test, an in-vitro diagnostic immunoassay for the quantitative determination of the protein Phospho-Tau (217P) in human plasma for use as an aid in identifying amyloid pathology. Recent data presented on Elecsys pTau217 showed that it was able to accurately detect amyloid pathology and was more stable than a pTau217/Aβ42 ratio in blood and plasma samples at room and refrigerator temperatures. Together with the high throughput and full automation of the assay, these data support the potential of Elecsys pTau217 as an accurate standalone test that could be scaled up for broad implementation in routine clinical practice worldwide across Roche’s unmatched installed base.
For more information, please visit www.roche.com.
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/. Last accessed: April 2025
