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Roche's pTau217 single-biomarker Alzheimer's blood test lands FDA approval
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Fusion42 · 24 August 2026 · Fusion42 review
Roche's Elecsys pTau217, a single-biomarker blood test for Alzheimer's disease, has received FDA clearance, providing clinicians with a new tool to assess amyloid pathology in patients aged 55 and older. This FDA approval follows the European CE mark and comes amid increasing competition in the Alzheimer's blood test market in the US.
This Wire brief sits within Fusion42's coverage of Diagnostics, and 3 sources have reported it between 24 Aug 2026 and 26 Aug 2026.
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You now have a new FDA-cleared diagnostic test that can serve both to confirm and exclude Alzheimer's in older patients. Use this to push for earlier diagnosis and trial enrolments before symptoms escalate.
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3 sources · first reported 24 Aug 2026 · latest 26 Aug 2026
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