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Analytical and clinical validation of the Simoa® Janssen plasma p217+ Tau assay as a CLIA lab developed test (LDT) for clinical use



The intersection of new therapeutic options for Alzheimer’s disease (AD), the emergence of accurate blood-based tests for AD, and the anticipated health system log jam for confirmatory diagnostic testing with traditional modalities, has elevated to an urgent level the need for accurate blood tests with the potential to serve as alternatives to PET and lumbar punctures for identifying amyloid pathology. Plasma p-Tau 217 has emerged as a biomarker with sufficient sensitivity and specificity to rule out and rule in amyloid pathology with high confidence, potentially serving as a readily scalable non-invasive test to support AD diagnosis and identification of patients who could benefit from drug therapy. In this poster, we describe analytical and preliminary clinical validation of a lab developed test (LDT) for plasma p-Tau 217 for clinical use.