Study summary
Four blood tests for Alzheimer's are now FDA-cleared
4blood tests cleared by the FDA
What was tested
Blood tests that measure forms of tau and amyloid to show whether amyloid is likely present in the brain, in place of a PET scan or spinal tap.
What they found
- The first, Lumipulse, was cleared in May 2025. 4 are cleared as of August 2026.
- Roche's test, cleared August 24, 2026, uses a single marker (pTau217) for adults 55 and older with symptoms.
- One test is cleared for adults as young as 40 with symptoms.
- They are meant to be read alongside a clinical assessment, not alone.
What it means
Makes it practical to confirm the disease in an ordinary clinic, which is the step that gates access to treatment.
Last reviewed 2026-11-14 by the Find a Trial editorial team.
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