Clinical validation of the LucentAD p-Tau 217 as a lab developed test (LDT) for clinical use
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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. Our objective is to clinically validate a lab developed test based on the Janssen plasma p217+ tau assay (rebranded LucentAD p-Tau 217) for clinical use. Download our poster to learn more.
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