Dr Emma Law - pTau217 Blood Test for Alzheimer's: What the FDA Clearance Means
About this episode
Dr Emma Law discusses the implications of the FDA clearance for Roche's pTau217 blood test on dementia research and recruitment.
Dr Emma Law narrates her blog written for Dementia Researcher. The FDA has cleared Roche's Elecsys pTau217 blood test to help identify amyloid pathology in people aged 55 and over who are already showing signs of cognitive decline. Most of the attention has gone to what that means for diagnosis and for access to new treatments. In this blog, Emma takes a different angle, asking what it changes for the people who design and deliver dementia studies. Her view is that a clearance like this reshapes the economics of recruitment, opens up questions about the earliest stages of disease that were previously too expensive to ask, and moves some of the most important work towards understanding how biomarkers get used in practice rather than towards discovering new ones. She is also clear that imaging is not being replaced, and that the researchers who do best over the next decade will be the ones who know how to combine the two. https://www.dementiaresearcher.nihr.ac.uk/ptau217-blood-test-what-fda-clearance-means/ -- Dr Emma Law is Strategic Manager for the The Neuroprogressive and Dementia Network in Scotland. Emma has 13 years experience as a Clinical Trails Network Manager and over 35…
People in this episode
Guest: Dr Emma Law
Topics covered
- Alzheimer's
- blood test
- FDA clearance
- dementia studies
- biomarkers
- clinical research
Keywords
- Alzheimer's
- pTau217
- blood test
- FDA
- dementia
- biomarkers
- clinical trials
Mentioned in this episode
Organizations: Roche, The Neuroprogressive and Dementia Network
Books & works: Elecsys pTau217 blood test
Places: Scotland
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