Publications
PrecivityAD® and PrecivityAD2™ Tests - Clinical Use
Clinical Validity/Clinical Performance
Palmqvist S, Tideman P, Mattsson-Carlgren N, et al. Blood Biomarkers to Detect Alzheimer Disease in Primary Care and Secondary Care. JAMA. 2024;332(15):1245-1257. doi:10.1001/jama.2024.13855
Meyer MR, Kirmess KM, Eastwood S, et al. Clinical validation of the PrecivityAD2 blood test: A mass spectrometry-based test with algorithm combining %p-tau217 and Aβ42/40 ratio to identify presence of brain amyloid. Alzheimers Dement. 2024;20(5):3179-3192. doi:10.1002/alz.13764
Ikanga J, Patel SS, Roberts BR, et al. Association of plasma biomarkers with cognitive function in persons with dementia and cognitively healthy in the Democratic Republic of Congo. Alzheimers Dement (Amst). 2023;15(4):e12496. doi:10.1002/dad2.12496
Rissman RA, Langford O, Raman R, et al. Plasma Aβ42/Aβ40 and phospho-tau217 concentration ratios increase the accuracy of amyloid PET classification in preclinical Alzheimer's disease. Alzheimers Dement. 2024;20(2):1214-1224. doi:10.1002/alz.13542
Fogelman I, West T, Braunstein JB, et al. Independent study demonstrates amyloid probability score accurately indicates amyloid pathology. Ann Clin Transl Neurol. 2023; 10(5), 765–778. doi.org/10.1002/acn3.51763
Hu Y, Kirmess KM, Meyer MR, et al. Assessment of a plasma amyloid probability score to estimate amyloid positron emission tomography findings among adults with cognitive impairment. JAMA Netw Open. 2022;5:e228392. doi:10.1001/jamanetworkopen.2022.8392
West T, Kirmess KM, Meyer MR, et al. A blood-based diagnostic test incorporating plasma Aβ42/40 ratio, ApoE proteotype, and age accurately identifies brain amyloid status: findings from a multi cohort validity analysis. Mol Neurodegener. 2021;16(1):30. doi:10.1186/s13024-021-00451-6
Analytical Validity
Eastwood SM, Meyer MR, Kirmess KM, et al. PrecivityAD2™ blood test: Analytical validation of an LC-MS/MS assay for quantifying plasma phospho-tau217 and non-phospho-tau217 peptide concentrations that are used with plasma amyloid-β42/40 in a multianalyte assay with algorithmic analysis for detecting brain amyloid pathology. Diagnostics (Basel). 2024;14(16):1739. doi:10.3390/diagnostics14161739
Kirmess KM, Meyer MR, Holubasch MS, et al. The PrecivityAD™ test: Accurate and reliable LC-MS/MS assays for quantifying plasma amyloid beta 40 and 42 and apolipoprotein E proteotype for the assessment of brain amyloidosis. Clin Chim Acta. 2021;519:267-275. doi:10.1016/j.cca.2021.05.011
Clinical Utility
Monane M, Maraganore DM, Carlile RM, et al. Clinical Utility of an Alzheimer’s Disease Blood Test Among Cognitively Impaired Patients: Results from the Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey Study. Diagnostics. 2025; 15(2):167. doi.org/10.3390/diagnostics15020167
Economic Utility
Monane MM, Johnson KG, Snider, BJ, et al. A blood biomarker test for brain amyloid impacts clinical decision making among memory specialists in the evaluation of cognitive impairment. Ann Clin Transl Neurol. 2023;10(10):1738-1748. doi:10.1002/acn3.51863
Canestaro WJ, Bateman RB, Holtzman DM, et al. Use of a blood biomarker test improves economic utility in the evaluation of older patients presenting with cognitive impairment. Popul Health Manag. 2024;27(3):174-184. doi:10.1089/pop.2023.0309
Special Populations
Brier MR, Schindler SE, Salter A, et al. Unexpected low rate of amyloid-β pathology in Multiple Sclerosis patients. Ann Neurol. 2024;96:453-459. doi:10.1002/ana.27027
Mohs RC, Beauregard D, Dwyer J, et al. The Bio-Hermes Study: Biomarker database developed to investigate blood-based and digital biomarkers in community-based, diverse populations clinically screened for Alzheimer's disease. Alzheimer’s Dement. 2024;20:2752–2765. doi:10.1002/alz.13722
Pre-Analytical–Optimizing Specimen Collection, Processing, and Shipping
Verberk IMW, Misdorp EO, Koelewijn J, et al. Characterization of pre-analytical sample handling effects on a panel of Alzheimer's disease-related blood-based biomarkers: Results from the Standardization of Alzheimer's Blood Biomarkers (SABB) working group. Alzheimer’s Dement. 2022;18(8):1484-1497. doi:10.1002/alz.12510
Xiong C, Luo J, Wolk DA, et al. Baseline levels and longitudinal changes in plasma Aβ42/40 among Black and white individuals. Nat Commun. 2024;15(1):5539. doi:10.1038/s41467-024-49859-w
Molina-Henry DP, Raman R, Liu A, et al. Racial and ethnic differences in plasma biomarker eligibility for a preclinical Alzheimer's disease trial. Alzheimers Dement. 2024;20(6):3827-3838. doi:10.1002/alz.13803
Biomarker Relationships with Racial and Ethnic Diversity
Fischer B, Van Hulle CA, Langhough R, et al. Plasma Aβ42/40 and cognitive variability are associated with cognitive function in Black Americans: Findings from the AA-FAIM cohort. Alzheimer’s Dement (N Y). 2023;9:e12414. doi:10.1002/trc2.12414
Schindler SE, Karikari TK, Ashton NJ, et al. Effect of race on prediction of brain amyloidosis by plasma Aβ42/Aβ40, phosphorylated tau, and Neurofilament light. Neurology. 2022;99(3):e245-e257. doi:10.1212/WNL.0000000000200358
Cooley SA, Nelson B, Boerwinkle A, et al. Plasma Aβ42/Aβ40 ratios in older people with human immunodeficiency virus. Clin Infect Dis. 2023;76(10):1776-1783. doi:10.1093/cid/ciad001
Considerations for Implementation in Clinical Practice
Angioni D, Delrieu J, Hansson O, et al. Blood Biomarkers from Research Use to Clinical Practice: What Must Be Done? A Report from the EU/US CTAD Task Force. J Prev Alzheimers Dis. 2022;9(4):569-579. doi:10.14283/jpad.2022.85
Galasko DR, Grill JD, Lingler JH, Heidebrink JL; Symptomatic Subcommittee of the Advisory Group on Risk Evidence Education for Dementia (AGREEDementia). A Blood Test for Alzheimer's Disease: It's about Time or Not Ready for Prime Time?. J Alzheimers Dis. 2022;90(3):963-966. doi:10.3233/JAD-215490
Anderson J, Pierce C. PrecivityAD for Diagnosis of Alzheimer Disease. Am Fam Physician. 2022;105(1):79-81. Free access link
Mielke MM, Anderson M, Ashford JW, et al. Considerations for widespread implementation of blood-based biomarkers of Alzheimer's disease. Alzheimers Dement. 2024;20(11):8209-8215. doi:10.1002/alz.14150
Mielke MM, Anderson M, Ashford JW, et al. Recommendations for clinical implementation of blood-based biomarkers for Alzheimer's disease. Alzheimers Dement. 2024;20(11):8216-8224. doi:10.1002/alz.14184
Schindler SE, Galasko D, Pereira AC, et al. Acceptable performance of blood biomarker tests of amyloid pathology - recommendations from the Global CEO Initiative on Alzheimer’s disease. Nat Rev Neurol. 2024;20(7):426-439. doi:10.1038/s41582-024-00977-5