Evidence map›Paper›PMID 38491912›Full record

ArticleAlzheimer's & dementia : the journal of the Alzheimer's Association2024

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.

Matthew R Meyer, Kristopher M Kirmess, Stephanie Eastwood, Traci L Wente-Roth, Faith Irvin, Mary S Holubasch, Venky Venkatesh, Ilana Fogelman, Mark Monane, Lucy Hanna and 15 more

Registry-linked trialOpen access · hybridAbstract readValidation Study
In one paragraph

Article in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06856681 (A Study of the Clinical Effect of the Implementation of a Blood Biomarker Into Memory Clinics in the Department of Veterans Affairs and Other Closed System Healthcare Memory and Dementia Sites in the United States), which is not on this map. Cited by 88 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
88citing papers in PubMed, 2 pooled it
31.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06856681 nawithdrawnnot on this mapstarted 2025, after this paper: background citation

A Study of the Clinical Effect of the Implementation of a Blood Biomarker Into Memory Clinics in the Department of Veterans Affairs and Other Closed System Healthcare Memory and Dementia Sites in the United States

TypeinterventionalSponsorC2N DiagnosticsRan2025 to 2028Enrolled0ConditionsAlzheimers DiseaseArmsPrecivityAD2 - Early Testing, PrecivityAD2 - Delayed Testing
3 · Its place in the literature

Who cites it

88 citing papers in PubMed, 2 syntheses or guidelines pooled it, 95 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Trial
  5. ABBV-552 in patients with mild Alzheimer's disease: a randomized phase IIb trial.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Trial
  6. Article
  7. Article
  8. Plasma eMTBR-tau243 as a disease biomarker across Alzheimer's disease clinical phenotypes.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Article
  9. Brain-derived plasma p-tau217 shows enhanced dynamic range for Alzheimer's disease neuropathological change.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Article
  10. Article
  11. Exploring longitudinal relationships among Alzheimer's disease biomarkers.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Article
  12. Review
  13. Review
  14. Prognostic value of plasma %p-tau217 in cognitively unimpaired older adults.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Article
  15. Article
  16. Article
  17. Article
  18. Usage and positivity rates of Alzheimer's disease biomarkers in a memory clinic.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Article
  19. Article
  20. Analytical and clinical validation of the Lumipulse G plasma p-tau217 assay for clinical implementation.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Article

28 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 8 institutions in 2 countries.

Matthew R MeyerC2N Diagnostics, St. Louis, Missouri, USA.
Kristopher M KirmessC2N Diagnostics, St. Louis, Missouri, USA.
Stephanie EastwoodC2N Diagnostics, St. Louis, Missouri, USA.
Traci L Wente-RothC2N Diagnostics, St. Louis, Missouri, USA.
Faith IrvinC2N Diagnostics, St. Louis, Missouri, USA.
Mary S HolubaschC2N Diagnostics, St. Louis, Missouri, USA.
Venky VenkateshC2N Diagnostics, St. Louis, Missouri, USA.
Ilana FogelmanC2N Diagnostics, St. Louis, Missouri, USA.
Mark MonaneC2N Diagnostics, St. Louis, Missouri, USA.
Lucy HannaCenter for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island, USA.
Gil D RabinoviciUCSF, San Francisco, California, USA.
Barry A SiegelSchool of Medicine, Washington University, St. Louis, Missouri, USA.
Rachel A WhitmerUC Davis, Sacramento, California, USA.
Charles ApgarAmerican College of Radiology, Philadelphia, Pennsylvania, USA.
Randall J BatemanSchool of Medicine, Washington University, St. Louis, Missouri, USA.
David M HoltzmanSchool of Medicine, Washington University, St. Louis, Missouri, USA.
Michael IrizarryEisai Inc., Nutley, New Jersey, USA.
David VerbelEisai Inc., Nutley, New Jersey, USA.
Pallavi SachdevEisai Inc., Nutley, New Jersey, USA.
Satoshi ItoEisai Co., Ltd., Tokyo, Japan.
John ContoisC2N Diagnostics, St. Louis, Missouri, USA.
Kevin E YarasheskiC2N Diagnostics, St. Louis, Missouri, USA.
Joel B BraunsteinC2N Diagnostics, St. Louis, Missouri, USA.
Philip B VergheseC2N Diagnostics, St. Louis, Missouri, USA.
Tim WestC2N Diagnostics, St. Louis, Missouri, USA.ORCID 0000-0003-3267-8249
C2N Diagnostics (United States) · USEisai (United States) · USWashington University in St. Louis · USAmerican College of Radiology · USBrown University · USCity College of San Francisco · USEisai (Japan) · JPUniversity of California Davis Medical Center · US

Funding

UC Davis Alzheimer's Disease Research CenterP30AG072972 · NIA · UNIVERSITY OF CALIFORNIA AT DAVIS · PI Charles DeCarli, Rachel A Whitmer · 2021 to 2026
$25.2M
Plasma Abeta isoform concentrations in cognitively impaired patients at risk for amyloidosisR44AG059489 · NIA · C2N DIAGNOSTICS, LLC · PI WEST, TIM · 2018 to 2020
$2.0M
Alzheimer's Drug Discovery Foundation GC-201711-2013978BrightFocus CA2016636Gerald and Henrietta Rauenhorst FoundationNIA NIH HHS P30 AG072972NIA NIH HHS R44 AG059489NIH HHS R44 AG059489
6 · The paper itself

Abstract

backgroundWith the availability of disease-modifying therapies for Alzheimer's disease (AD), it is important for clinicians to have tests to aid in AD diagnosis, especially when the presence of amyloid pathology is a criterion for receiving treatment.

methodsHigh-throughput, mass spectrometry-based assays were used to measure %p-tau217 and amyloid beta (Aβ)42/40 ratio in blood samples from 583 individuals with suspected AD (53% positron emission tomography [PET] positive by Centiloid > 25). An algorithm (PrecivityAD2 test) was developed using these plasma biomarkers to identify brain amyloidosis by PET.

resultsThe area under the receiver operating characteristic curve (AUC-ROC) for %p-tau217 (0.94) was statistically significantly higher than that for p-tau217 concentration (0.91). The AUC-ROC for the PrecivityAD2 test output, the Amyloid Probability Score 2, was 0.94, yielding 88% agreement with amyloid PET. Diagnostic performance of the APS2 was similar by ethnicity, sex, age, and apoE4 status. DISCUSSION: The PrecivityAD2 blood test showed strong clinical validity, with excellent agreement with brain amyloidosis by PET.

Indexed as

AlgorithmsAlzheimer DiseaseAmyloid beta-PeptidesBiomarkersBrainMass SpectrometryPeptide FragmentsPositron-Emission Tomographytau ProteinsAgedAged, 80 and overFemaleHumansMaleMiddle AgedROC CurveAmyloid beta-PeptidesBiomarkersPeptide Fragmentstau ProteinsAlzheimer'samyloid betablood biomarkerclinical validitydiagnosticp‐tau217

Identifiers

PMID38491912
PMCPMC11095426
OpenAlexW4392880455

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.