JAMA Medical News Alzheimer Disease Blood Test Approved for Primary Care
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Dec 5, 2025 Rita Rubin, Lead Senior Staff Writer for JAMA Medical News, dives into the recent FDA approval of a blood test for Alzheimer’s disease. She explains how this test measures phosphorylated tau‑217 and can rule out the disease but not confirm it. Concerns arise about primary care physicians testing inappropriate patients and the potential for delays in specialist access for follow-up. Rubin emphasizes the importance of responsible testing, particularly for asymptomatic individuals, and touches on the future of research in Alzheimer’s therapies.
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Blood Test Measures Tau-217 To Indicate Plaque
- Roche and Eli Lilly's blood test measures phosphorylated tau-217 as a proxy for brain amyloid plaque.
- The test is cleared to help rule out but not definitively rule in Alzheimer disease in primary care.
Test Designed To Rule Out, Not Confirm
- The Roche test is intended to rule out Alzheimer's when results are below a cutoff but cannot confirm the disease when above it.
- Patients with positive results still need PET scans or CSF analysis for confirmation, which are more costly and less accessible.
Positive Results Still Require Specialist Follow-Up
- A positive blood biomarker result lacks specificity and leaves patients needing specialist follow-up that may be delayed.
- Negative results can refocus clinicians to seek reversible causes of cognitive impairment like medications.