Roche receives CE mark for breakthrough Alzheimer’s plasma pTau217 blood test
Elecsys pTau217 is the first single-assay blood test designed to identify or rule out amyloid pathology across primary and secondary care
12 May 2026Industry news
Roche has announced that it has received a CE Mark for Elecsys® pTau217, a blood test developed in collaboration with Eli Lilly and Company. The assay is designed to measure the phosphorylated Tau (pTau) 217 protein, a critical indicator of amyloid pathology and a hallmark of Alzheimer’s disease.
Addressing barriers to early and accurate diagnosis
Improving access to tests that detect Alzheimer’s-related brain changes is essential to speeding up diagnosis. Currently, an estimated 75% of people living with dementia remain undiagnosed, and those who are diagnosed typically wait an average of 3.5 years after symptoms first appear.
Traditional methods to confirm amyloid pathology — such as positron emission tomography (PET) scans and cerebrospinal fluid (CSF) assessments — can be expensive, difficult to access, and perceived as invasive. The Elecsys pTau217 assay addresses these challenges by offering reliable detection of Alzheimer's pathology in individuals with early cognitive decline through a routine blood draw.
Clinical utility and study design
The Elecsys pTau217 CE Mark was granted based on data from retrospective studies of real-world populations at the earliest stages of Alzheimer’s, including subjective cognitive decline, mild cognitive impairment, and mild dementia. This ensures the test performs accurately at the 'dawn' of the disease, when timely intervention has the greatest potential to preserve independence.
The test utilizes the same high and low cutoffs across both primary and secondary care settings. This allows clinicians to 'rule in' or 'rule out' amyloid pathology in patients presenting with symptoms of cognitive decline, providing actionable data for immediate referral or management.
Impact on healthcare systems
By bringing advanced testing into routine care, Roche aims to reduce pressure on specialized healthcare systems. A positive result indicates a high likelihood of amyloid pathology, while a negative result suggests a low likelihood, allowing clinicians to avoid unnecessary invasive investigations and shift focus to other potential causes of cognitive symptoms.
Matt Sause, CEO of Roche Diagnostics, stated, “The launch of pTau217 marks a significant step in providing a simple, blood-based tool to diagnose Alzheimer's much earlier in the patient journey. Today, many people face a long and difficult path to a diagnosis. By bringing this advanced test into routine care, we are helping physicians support patients and families with an earlier assessment that is critical for timely intervention.”
Future availability
The Elecsys pTau217 assay is designed for high-throughput, full automation on Roche’s large global base of laboratory instruments. Following the CE Mark approval, Roche will implement the test in countries accepting the mark, with an FDA submission in the US expected later this year.
Want the latest science news straight to your inbox? Become a SelectScience member for free today>>
Frequently asked questions
How does the Roche Elecsys pTau217 blood test help in diagnosing Alzheimer’s disease?
The Elecsys pTau217 test measures the phosphorylated Tau 217 protein in the blood, which is a key indicator of amyloid pathology in the brain. By using a single-assay design with specific high and low cutoffs, the test helps clinicians 'rule in' or 'rule out' Alzheimer’s pathology in patients with early symptoms of cognitive decline. This provides a minimally invasive, faster, and more accessible alternative to traditional positron emission tomography (PET) scans or spinal fluid tests.
What are the benefits of using a plasma-based pTau217 test compared to traditional PET or CSF methods?
Current methods like PET scans and cerebrospinal fluid (CSF) assessments can be expensive, require specialized facilities, and are often perceived as invasive by patients. The plasma-based pTau217 test offers comparable accuracy while only requiring a routine blood draw. This allows for testing to occur earlier in the patient journey and within primary care settings, significantly reducing the average 3.5-year wait time for a diagnosis.
Who is the Elecsys pTau217 test intended for, and when will it be available in the US?
The test is intended for individuals experiencing early cognitive symptoms, such as mild cognitive impairment or subjective cognitive decline. Following the receipt of the CE Mark in May 2026, the test is being rolled out in countries that accept CE certification. Roche has indicated that an FDA submission for the US market is planned for later in 2026.
What are biomarkers?
Biomarkers are molecular indicators found in blood, tissue or other body fluids, which can be a sign of normal or abnormal processes. Unlike medical symptoms, which are reported subjectively by patients, biomarkers are measurable and reproducible, providing an objective assessment of changes in the body.
Why are biomarkers important in Alzheimer’s disease?
In people with Alzheimer's disease (AD), proteins beta-amyloid and phosphorylated Tau (pTau) build up in the brain, forming abnormal deposits known as amyloid plaques and tau tangles. Traditionally, these could only be detected through CSF analysis via lumbar puncture – an invasive procedure that is unpopular with patients and difficult to access – or through PET imaging scans, which are expensive and not widely available.
Blood-based biomarkers are transforming this landscape by making accurate diagnosis accessible for the first time, offering new opportunities to detect disease earlier and reach the millions currently going undiagnosed.
How can blood biomarkers transform Alzheimer's diagnosis?
Blood-based biomarkers can now detect proteins that indicate amyloid pathology at very low concentrations in the bloodstream, making biological diagnosis of AD more easily accessible for the first time using a simple blood draw. Blood-based biomarker testing offers a simpler, less invasive alternative to CSF and PET, providing clinicians across all care settings, from primary care to specialist clinics, with the tools they need to 'rule in' or 'rule out' AD. This represents a fundamental shift in how AD is diagnosed and managed.
What blood-based biomarker tests does Roche offer?
Roche now has an approved and expanding portfolio of blood-based biomarker tests for AD. The Elecsys® pTau217 Assay (CE Mark approved, May 2026) is the first blood test able to both 'rule in' and 'rule out' AD pathology.
A positive result indicates a high likelihood of amyloid pathology. A negative result indicates a low likelihood of amyloid pathology, which means patients can avoid unnecessary further testing for Alzheimer’s and focus can be redirected to other
potential causes of cognitive decline. An indeterminate result prompts additional testing to clarify diagnosis.
The ability to both confirm and exclude Alzheimer's pathology in a single blood test is what makes pTau217 a transformative step forward for patients, clinicians and health systems. The test is designed for use across all care settings, including primary care.
How are these tests delivered?
These tests are delivered via Roche's existing analyzers. This means they can be rapidly implemented in clinical practice as soon as regulatory approval is received, with no need for new infrastructure or equipment. This ensures patients can access these breakthrough tests as quickly as possible across all care settings.
Why is timely detection of AD important?
Timely detection of AD is critical. Early diagnosis enables patients to access new and emerging disease modifying therapies and participate in clinical trials, and empowers patients and their families to make informed decisions about legal, financial and care planning. Blood-based biomarker testing helps make early, accurate diagnosis accessible for the first time, potentially transforming outcomes for millions of people living with AD.