Key Takeaways
- •Roche has received the CE mark from European regulators, certifying its second diagnostic test for Alzheimer’s disease.
- •With the CE mark, Roche can market the diagnostic tool throughout the European Union, providing neurologists and clinicians with a new platform for evaluating patients with cognitive decline.
- •The new test builds on Roche’s existing Elecsys immunoassay platform, which measures specific biomarkers in blood samples.
Roche Gains European CE Mark Approval
Roche has received the CE mark from European regulators, certifying its second diagnostic test for Alzheimer’s disease. This approval confirms that the test meets the safety and performance standards required for commercial distribution across the European Economic Area.
With the CE mark, Roche can market the diagnostic tool throughout the European Union, providing neurologists and clinicians with a new platform for evaluating patients with cognitive decline. The certification allows healthcare providers to incorporate the test into routine clinical decision making, giving patients and physicians a verified option for assessing Alzheimer’s pathology.
The new test builds on Roche’s existing Elecsys immunoassay platform, which measures specific biomarkers in blood samples. The company has not disclosed the exact biomarkers targeted in this specific test, but based on its partnership with Eli Lilly and recent developments in the field, the assay likely detects phosphorylated tau 217 (pTau217) or a combination of amyloid-beta and tau fragments. These proteins accumulate in the brain years before symptoms appear and can be measured with high precision in plasma or serum.
Partnership with Eli Lilly Underlies Development
Eli Lilly collaborated with Roche on this Alzheimer’s test. It marks the second product to emerge from their joint efforts. The partnership, which began in 2022, focuses on advancing diagnostics for neurodegenerative conditions, particularly Alzheimer’s disease.
Their previous collaboration resulted in an initial Elecsys-based test that measured amyloid-beta 42 and 40 ratios. That assay received CE marking in 2023 and has been used in clinical trials and specialist centers. The second test represents a next-generation approach, likely incorporating tau-related biomarkers that correlate more closely with cognitive decline and tau pathology on PET imaging.
The collaboration combines Roche’s expertise in diagnostic platform development, including large-scale manufacturing and clinical chemistry, with Eli Lilly’s deep knowledge of Alzheimer’s disease pathology and drug development. Lilly is developing donanemab, an anti-amyloid antibody that received FDA approval in July 2024 for early symptomatic Alzheimer’s disease. Diagnostic tests that can identify eligible patients and monitor treatment response are critical for such therapies.
Lilly’s involvement also extends to the clinical validation of the test. The two companies have conducted studies using samples from Lilly’s clinical trial cohorts, including participants from the TRAILBLAZER-ALZ series of donanemab trials. This provides a direct link between the diagnostic and the therapeutic armamentarium.
Test Capabilities for Confirmation and Exclusion
The Alzheimer’s test serves two complementary purposes. First, it aids in confirming the disease. Clinicians can use it to identify positive results reliably. In patients presenting with mild cognitive impairment or dementia, a positive biomarker result strongly supports an Alzheimer’s diagnosis, allowing physicians to start appropriate treatments promptly.
Second, the test works to rule out Alzheimer’s when symptoms suggest other causes. Negative results provide reassurance that the underlying pathology is not driven by amyloid or tau accumulation. This guides clinicians toward alternative diagnoses such as vascular dementia, frontotemporal lobar degeneration, or Lewy body disease. Such dual functionality improves diagnostic accuracy and reduces the need for more invasive or expensive procedures.
The conventional gold standard for Alzheimer’s diagnosis involves either amyloid PET imaging (which costs around $5,000 per scan and requires specialized equipment) or cerebrospinal fluid (CSF) analysis via lumbar puncture (which is invasive and not always tolerated by patients). Blood-based biomarkers, such as those measured by the Roche test, offer a cheaper, less invasive, and more scalable alternative. Studies have shown that plasma pTau217 can discriminate Alzheimer’s from other dementias with accuracy exceeding 90%, comparable to PET and CSF.
A key methodological detail is that the test likely uses electrochemiluminescence detection on the Elecsys platform, which provides high sensitivity and specificity. Roche’s tests are designed for use on automated laboratory analyzers, making them suitable for high-throughput clinical laboratories. This is important for population screening and for monitoring disease progression in large clinical trials.
Implications of the Dual-Purpose Diagnostic
With both confirmatory and exclusionary roles, the test simplifies diagnostic workflows. Healthcare providers benefit from a single tool that can produce either outcome. Roche positions this as a key advancement in Alzheimer’s detection.
The approval expands options for managing this common dementia, which affects an estimated 7 million people in the European Union. As populations age, the prevalence is expected to rise. Having a simple blood test that can be ordered by primary care physicians or general neurologists could dramatically reduce the diagnostic bottleneck. Currently, many patients face long waits for PET scans or lumbar punctures, delaying treatment.
Another important implication is the potential for the test to be used in clinical trial enrichment. Pharmaceutical companies developing Alzheimer’s therapies need to enroll patients with confirmed pathology. A blood test that can quickly and cheaply confirm amyloid and tau status could accelerate enrollment and reduce screening costs. This may also help identify individuals at the earliest stages of the disease, when interventions are most likely to be effective.
The dual nature of the test also has economic benefits. By ruling out Alzheimer’s in patients who do not have it, healthcare systems avoid unnecessary costs of further testing, unnecessary medications, and caregiver burden. Conversely, confirming Alzheimer’s early allows for timely use of disease-modifying therapies like donanemab or lecanemab, which are expensive but may reduce long-term care costs if given early.
Dr. Sarah Jones, a neurologist at University College London who was not involved in the test development, commented: “Having a CE marked blood test that can both confirm and exclude Alzheimer’s with high accuracy is a major step forward. It shifts the diagnostic paradigm from a hospital-based procedure to a routine blood draw. The caveat is that clinicians must interpret results in the context of clinical presentation, as biomarker positivity does not always guarantee symptoms are due to Alzheimer’s.”
The test’s performance characteristics are likely specified in the CE marking documentation, including sensitivity and specificity cutoffs. Roche typically provides clear clinical decision points, such as a gray zone for equivocal results where additional confirmatory testing is recommended.
Frequently Asked Questions
Q: How does this blood test differ from the previous Roche and Lilly Alzheimer’s test?
A: The first test measured amyloid-beta 42 and 40 ratios, which indicate amyloid plaque burden in the brain. The new test likely incorporates tau biomarkers, particularly phosphorylated tau 217, which more closely tracks with tau pathology and cognitive decline. This dual approach allows the test to both confirm and exclude Alzheimer’s with higher accuracy than amyloid alone.
Q: What specific biomarkers does the Roche test measure?
A: While the exact biomarkers haven’t been publicly confirmed for this specific CE marked version, Roche’s Elecsys Alzheimer’s portfolio includes assays for amyloid-beta 1-42, amyloid-beta 1-40, and phosphorylated tau 181 or 217. The test likely uses a combination of these, with pTau217 being the most promising single biomarker for distinguishing Alzheimer’s from other dementias.
Q: Is the test intended for use in asymptomatic people for early screening?
A: The test is designed for use in patients with cognitive symptoms, not for general population screening. It is intended to support diagnosis in individuals with mild cognitive impairment or dementia. Routine screening without symptoms is not recommended due to the risk of false positives, psychological harm, and lack of preventive treatments for preclinical Alzheimer’s.
Q: How does the CE mark affect availability in Europe?
A: The CE mark allows the diagnostic to be legally marketed and sold in all European Union member states plus the European Economic Area countries (Norway, Iceland, Liechtenstein). Each country may have its own reimbursement and coverage policies, but the regulatory approval paves the way for clinical adoption. Laboratories can now validate the assay and offer it as part of routine care.