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FDA Approves 2 New Alzheimer Disease Blood Tests
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Fusion42 · 19 September 2026 · Fusion42 review
The FDA approved two new blood tests capable of detecting Alzheimer disease in adults with cognitive symptoms, including a test for patients as young as 40 years old. One test uses a single biomarker, pTau217, for patients 55 and older, while the other assesses β-amyloid and tau peptide ratios and is validated for adults from 40 years onwards.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
You can now build diagnostic services targeting younger adults with cognitive symptoms, as these FDA approvals open up market access for earlier-stage Alzheimer detection. Prepare to integrate these blood tests into your clinical offerings to capture patients below traditional age thresholds.
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1 source · 19 Sep 2026
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