Roche has received CE Mark approval for Elecsys pTau217, a blood-based diagnostic test developed in collaboration with Eli Lilly and Company for the detection of amyloid pathology associated with Alzheimer’s disease. The test is designed to measure phosphorylated Tau (pTau) 217 protein, a key biomarker and hallmark of Alzheimer’s disease, helping clinicians identify or rule out amyloid pathology in individuals experiencing cognitive decline.

The company stated that the same high and low cutoff values can be applied across both primary and secondary care settings, allowing broader use of the test in routine clinical practice. Early identification of amyloid pathology is considered critical in Alzheimer’s diagnosis and treatment, enabling patients, caregivers and healthcare professionals to make timely care and management decisions.

Matt Sause, CEO of Roche Diagnostics, said the launch of the blood-based assay marks a significant advancement in simplifying Alzheimer’s diagnosis earlier in the patient journey. He noted that many individuals currently face prolonged diagnostic delays and often depend on specialised care and costly procedures such as PET scans and cerebrospinal fluid assessments.

Carole Ho, Executive Vice President and President of Lilly Neuroscience, said, “The collaboration was driven by a shared objective to make Alzheimer’s testing more accessible and practical in routine healthcare settings, allowing patients and families to receive earlier assessments and make informed decisions regarding future care.”

According to Roche, an estimated 75 percent of people living with dementia worldwide remain undiagnosed, with diagnosis often occurring several years after symptoms of cognitive decline first appear. Existing diagnostic methods, including PET imaging and cerebrospinal fluid testing, can be expensive, difficult to access and more invasive compared to blood-based testing.

The CE Mark approval was supported by retrospective studies involving individuals at the earliest stages of Alzheimer’s disease, including those with Subjective Cognitive Decline, Mild Cognitive Impairment and Mild Dementia. Roche stated that the focus on early-stage populations was intended to ensure the test performs effectively when early intervention may offer the greatest benefit.

A positive Elecsys pTau217 test result indicates a high likelihood of amyloid pathology linked to Alzheimer’s disease and may help primary care physicians make timely referrals for specialist evaluation. A negative result suggests a low likelihood of amyloid pathology, potentially reducing the need for further invasive diagnostic procedures. Indeterminate results would require additional clinical evaluation and testing.

Roche noted that the assay is designed to support routine laboratory workflows through automated, high-throughput processing across the company’s existing installed diagnostic infrastructure. Following CE Mark approval, the company plans to make the test widely available in countries recognising the CE mark, with potential expansion into the United States subject to FDA approval later this year.

The company also highlighted its broader Alzheimer’s portfolio spanning diagnostics and investigational therapies. Roche is currently developing therapies including trontinemab, an investigational amyloid-beta targeting monoclonal antibody undergoing phase 3 trials, and nivegacetor, an oral gamma-secretase modulator in phase II development for Alzheimer’s disease.