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FDA clears new blood-based biomarker test that targets tau
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Fusion42 · 25 August 2026 · Fusion42 review
Roche received FDA clearance for the Elecsys Phospho-Tau (217P) Plasma blood test, a biomarker assay targeting tau protein for assessing Alzheimer's disease in adults 55 and older, enabling less invasive and more accessible amyloid pathology screening before PET imaging.
This Wire brief sits within Fusion42's coverage of Digital Health, and 3 sources have reported it between 25 Aug 2026 and 3 Sep 2026.
◆ ◆ The Wire takeaway
Roche’s FDA clearance means you can now develop non-invasive blood tests to screen Alzheimer’s patients earlier and more cheaply, shifting referrals away from costly PET scans. This opens access for diagnostics startups to integrate into routine care pathways and reshape Alzheimer’s detection.
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3 sources · first reported 25 Aug 2026 · latest 3 Sep 2026
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