Roche secured CE marking in Europe for its Elecsys plasma pTau217 blood test, intended to help rule in and rule out amyloid pathology. The company developed the test with Eli Lilly, adding another blood-based tool for Alzheimer’s diagnosis after Fujirebio Diagnostics’ blood test received FDA approval last year. Roche’s move strengthens the company’s position in the rapidly growing blood biomarkers market by improving access to earlier diagnostic stratification for patients who may be candidates for disease-modifying therapies. The expansion also highlights how companies are pairing pathology biomarkers with companion clinical workflows to move from specialist assessment toward broader screening and monitoring in real-world settings.
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