Roche has grabbed a European CE mark for its second Alzheimer’s test that can both confirm the disease and help rule it out.
The Elecsys pTau217, developed in conjunction with Eli Lilly, is a blood test designed to detect phosphorylated Tau (pTau) 217 protein, a hallmark of Alzheimer’s disease that has been linked to the presence of amyloid plaque buildup in the brain.
High levels indicate a greater likelihood that a patient has Alzheimer’s disease, while low levels can help rule out the disease in those experiencing cognitive impairment.
The test can be used across primary and secondary care settings, Roche said in a May 11 statement.
This is the second Alzheimer’s test to come from the Swiss drug and diagnostics maker.
Last July, Roche received European approval for its first blood test designed to help rule out Alzheimer’s disease.
Related
That test, also called Elecsys and developed with Lilly, detects phosphorylated tau-181 protein in the blood.
“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,” Matt Sause, CEO of Roche Diagnostics, said in a release.
“Today, many people face a long and difficult path to a diagnosis, often relying on specialized care and costly procedures. 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, while reducing pressure on healthcare systems.”
