Question from a Member:
Is it now standard of care/appropriate to order p-Tau217, a biomarker for Alzheimer’s disease? [I read an article that said that this test] is the earliest biomarker detection of risk, well over 20 years in advance.
What our Member is referring to is a blood test, the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, cleared for marketing by the United States Food and Drug Administration (FDA, 2025).
The FDA’s news release noted that this test is “the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease” (emphasis in red added by us).
The FDA clearance of this test is for ((FDA, 2025; emphasis in red added by us):
1. “Adult patients, aged 55 years and older“
2. “exhibiting signs and symptoms of the disease.”
About the prevalence of Alzheimer’s disease, the FDA’s news release noted that (FDA, 2025):
– Alzheimer’s disease is present in 10% of people aged 65 and older, and
– The prevalence is expected to DOUBLE by 2050!
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