Roche has secured CE mark for the Elecsys pTau217 blood test, developed alongside Eli Lilly, for detecting Alzheimer’s disease pathology.
The test is designed for measuring the phosphorylated Tau (pTau) 217 protein, a key indicator of amyloid pathology, often associated with Alzheimer’s.
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The blood test uses standard thresholds to rule in or rule out amyloid pathology in individuals showing cognitive decline and is intended for application in both primary and secondary care settings.
This enables earlier detection of Alzheimer’s pathology through a minimally invasive method.
The CE mark for Elecsys pTau217 was granted based on outcomes from retrospective studies in real-world population experiencing subjective cognitive decline, mild cognitive impairment, and mild dementia.
These are periods where memory changes are noticeable, but individuals can largely live independently.
A positive pTau217 test result suggests a high likelihood of amyloid pathology, aiding clinicians with timely referrals and further evaluation.
Negative results indicate a low likelihood, reducing the need for further invasive testing and freeing specialist resources. Indeterminate results require additional testing, and the test should be used with other clinical data.
The Elecsys pTau217 assay is designed for routine workflows, available on Roche’s installed instrument base.
With the latest approval, laboratories across CE-mark-accepting countries can now access the test, with possible US rollout pending approval from the US Food and Drug Administration (FDA).
Roche Diagnostics CEO Matt Sause said: “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, often relying on specialised care and costly procedures.
“By bringing this advanced test into routine care, we are helping physicians to support patients and families with an earlier assessment that is critical for timely intervention, while reducing pressure on healthcare systems.”
Last month, Roche received CE mark approval of its Elecsys neurofilament light chain (NfL) test, which is designed to detect neuroinflammation in patients with relapsing remitting multiple sclerosis.
