Affiliations: [a] Department of Neurology, Case Western Reserve University School of Medicine, Cleveland, OH, USA
| [b] Department of Neurology, University Hospitals Cleveland Medical Center, Cleveland, OH, USA
Correspondence:
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Correspondence to: Alan J. Lerner, MD, 3619 Park East Drive, Beachwood, OH 44122, USA. Tel.: +1 216 464 6449; E-mail: alan.lerner@case.edu.
Abstract: After years of anticipation, non-invasive tests for detecting cerebral amyloidosis and Alzheimer’s disease (AD) are entering clinical care. The PrecivityADtrademark test from C2N is a plasma-based test yielding an Amyloid Probability score with high sensitivity and specificity for brain amyloid accumulation, but some samples may have inconclusive results. The AGREEDementia consortium raised concerns that the field needs study of how best to use and communicate results of PrecivityADtrademark. Continued attention and mindfulness should be applied to the whole class of dementia biomarker tests and directed in light of FDA biomarker context of use framework. Unintended uses of biomarkers tests may have unintended consequences, such as mislabeling patients. AD biomarker tests may efficiently stratify AD risk but will inevitably be included in electronic medical records and be subject to interpretation by medical personnel lacking proper knowledge or context to interpret results appropriately. Another way forward is mindful discussion and consensus among all stakeholders about the uses and limits of each specific test.
