Header: We often complain about the path to clinical adoption in precisoin medicine. Alzheimer's biomarkers are booming with large scale, powerful, accurate studies. Perhaps in no small part to a crystal-clear project for the future, laid out in 2022 by Hansson et al.
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One of the most active and fast-moving areas of diagnostics is Alzheimer's disease. There is a boom in large, well-designed studies on the new generations of proteomic tests that are reaching the Holy Grail of accurate-plasma based diagnoses. Such tests promise to supercede costly and uncommon PET and CSF tests.
See a current "most read" Palmqvist paper in JAMA on the accuracy of phos-Tau-217. See a detailed press release from the international Alzheimer's meeting last month. The documents refer back to a 2022 appropriate use criteria (AUC) for plasma biomarkers in dementia - Hansson et al. These 2022 AUC are perhaps a little dated now, only in that so much highly positive confirmatory research has appeared in 2023 and 2024 -- making their 2022 reservations less necessary.
Here's my point. It's well known that new technologies often hear a wall, or at least high barriers, to implementation. Horgan et al. 2024 are the best recent paper on "bridging the gap" to the clinic (my blog here).
Hansson et al. 2022 is more than one report - it's a case study
Reading it carefully, I realized that Hansson et al., the AUC on blood biomarkers, is more than just one good report. It's a rare example of a "master class" in assessing the present and laying out a roadmap for the near future.
Both a Project and a Paradigm Approach
The Hansson et al. paper is in the first place, a significant contribution to the field of blood-based biomarkers (BBMs) in Alzheimer's disease (AD). However, its value extends far beyond being just another set of specific Appropriate Use Criteria (AUC) for one scenario. From A to Z, it serves as a paradigm of forward-thinking in medical diagnostics, offering not only a thorough and up-to-date review of the current state of BBMs but also projecting into the future with well-justified and creative recommendations for clinical use and research directions.
The authors have provided a comprehensive roadmap that identifies the gaps in current knowledge - that's hard enough. They then have thought-through and prospoed detailed future steps to fill these gaps, making it an essential case study for anyone involved in the implementation of new medical technologies. The authors emphasize the need for continued research in areas such as the robustness of BBMs across diverse populations, the development of new assays, and the integration of BBMs into clinical trials. They also highlight the importance of using BBMs not just for diagnosis but as tools to accelerate the development and validation of new treatments. Much of this is happening in 2023, 2024, perhaps aided by the clarity of planning in 2022.
Health Policy to Commercialization
For those in the fields of diagnostics, commercialization, and health policy—areas often criticized for their slow pace—this paper offers a blueprint for how to approach the rapid implementation of new technologies. By systematically addressing current limitations and providing a clear path forward, Hansson et al. exemplify how to bridge the gap between innovation and clinical application. This is a model not just for Alzheimer’s disease but for the broader medical community looking to integrate novel diagnostics into routine care.
I was so favorably struck by this as a "case study" independent of its particular topic, because I have worked in strategy consulting for 20 years. Every work phase - assessing the present, enumerating the gap analysis, and then projecting multiple lines of work into the future - is hard. Strategists and policymakers should study Hansson et al. as a template for advancing the adoption of emerging technologies across various fields of medicine. And getting over the cliche' that it takes 10 or 15 years to bring innovation to the clinic.
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