PrecivityAD® Blood Assay Publications

A blood biomarker test for brain amyloid impacts the clinical evaluation of cognitive impairment

Mark Monane, Kim G. Johnson, B. Joy Snider, Raymond S. Turner, Jonathan D. Drake, Demetrius M. Maraganore, James L. Bicksel, Daniel H. Jacobs, Julie L. Ortega, Joni Henderson, Yan Jiang, Shuguang Huang, Justine Coppinger, Ilana Fogelman, Tim West, & Joel B. Braunstein

Annals of Clinical and Translations Neurology, August 8, 2023. https://onlinelibrary.wiley.com/doi/epdf/10.1002/acn3.51863

Independent study demonstrates amyloid probability score accurately indicates amyloid pathology

Ilana Fogelman, MD, MPH; Tim West, PhD; Joel B. Braunstein, MD, MBA, Philip B. Verghese, PhD, Kristopher M. Kirmess, PhD; Matthew R. Meyer, PhD; John H. Contois, PhD; Eli Shobin, PhD; Kyle L. Ferber, PhD; Jake Gagnon, PhD; Carrie E. Rubel, PhD; Danielle Graham, PhD; Randall J. Bateman, MD; David M. Holtzman, MD; Shuguang Huang PhD; Joanne Yu, MS; Sha Yang, MA; Kevin E. Yarasheski, PhD

Annals of Clinical and Translational Neurology, March 28, 2023 (https://doi.org/10.1002/acn3.51763)

Head-to-head comparison of 10 plasma phospho-tau assays in predromal Alzheimer’s disease

Shorena Janelidze, Divya Bali, Nicholas J. Ashton, Nicolas R Barthélemy, Jeroen Vanbrabant, Erik Stoops, EugeenVanmechelen,Yingxin He, Anna Orduña Dolado, Gallen Triana-Baltzer, Michael J. Pontecorvo, Henrik Zetterberg, Hartmuth Kolb, Manu Vandijck,Kaj Blennow, Randall J. Bateman and Oskar Hansson

Brain, September 10, 2022 (https://doi.org/10.1093/brain/awac333)

Assessment of a Plasma Amyloid Probability Score to Estimate Amyloid Positron Emission Tomography Findings Among Adults With Cognitive Impairment

Yan Hu, PhD, Kristopher M. Kirmess, PhD, Matthew R. Meyer, PhD, Gil D. Rabinovici, MD, Constantine Gatsonis, PhD, Barry A. Siegel, MD, Rachel A. Whitmer, PhD, Charles Apgar, MBA, Lucy Hanna, MS, Michio Kanekiyo, MS, June Kaplow, PhD, Akihiko Koyama, PhD, David Verbel, MPH, Mary S. Holubasch, BS, Stephanie S. Knapik, BS, Jason Connor, PhD8, John H. Contois, PhD, Erin N. Jackson, MS, Scott E. Harpstrite, BS, Randall J. Bateman, MD9, David M. Holtzman, MD9, Philip B. Verghese, PhD, Ilana Fogelman, MD, Joel B. Braunstein, MD, Kevin E. Yarasheski, PhD, Tim West, PhD

JAMA Open Network, 5 (2022). (https://doi.org/10.1001/jamanetworkopen.2022.8392)

• Clinical validation of the PrecivityAD® test.

  
  

Effect of Race on Prediction of Brain Amyloidosis by Plasma Aβ42/Aβ40, Phosphorylated Tau, and Neurofilament Light

Suzanne E. Schindler, MD, PhD, Thomas K Karikari, PhD, Nicholas J Ashton, PhD, Rachel L Henson, MS, Kevin E Yarasheski, PhD, Tim West, PhD, Mathew R Meyer, PhD, Kristopher M Kirmess, PhD, Yan Li, PhD, Benjamin Saef, MS,Krista L Moulder, PhD, David Bradford, Anne M Fagan, PhD, Brian A Gordon, PhD, Tammie L.S. Benzinger, MD, PhD, Joyce Balls-Berry, PhD, Randall J Bateman, MD, Chengjie Xiong, PhD, Henrik Zetterberg, MD, PhD, Kaj Blennow,MD, PhD,  John C Morris, MD

Neurology - First published April 21, 2022 https://n.neurology.org/content/early/2022/04/22/WNL.0000000000200358

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

Kirmess KM, Meyer MR, Holubasch MS, Knapik SS, Hu Y, Jackson EN, Harpstrite SE, Verghese PB, West T, Fogelman I, Braunstein JB, Yarasheski KE, Contois JH

Clinica Chimica Acta, 519 (2021).  (https://doi.org/10.1016/j.cca.2021.05.011)

• Description of the analytical validation of the PrecivityAD® test.

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.

West T, Kirmess KM, Meyer MR, Holubasch MS, Knapik SS, Hu Y, Contois JH, Jackson EN, Harpstrite SE, Bateman RJ, Holtzman DM, Verghese PB, Fogelman I, Braunstein JB, Yarasheski KE

Molecular Neurodegeneration 16(1):30 (2021). (https://doi.org/10.1186/s13024-021-00451-6)

• Proof-of-concept study showing that measuring ApoE, Aβ40, and Aβ42 by mass spectrometry can be used to identify brain amyloid status in patients from multiple different clinical cohorts.

High-precision plasma β-amyloid 42/40 predicts current and future brain amyloidosis.

Schindler SE, Bollinger JG, Ovod V, Mawuenyega KG, Li Y, Gordon BA, Holtzman DM, Morris JC, Benzinger TLS, Xiong C, Fagan AM, Bateman RJ

Neurology 93:e1647–e1659 (2019). (https://n.neurology.org/content/93/17/e1647)

• Initial description of the mass spectrometry based assay that the PrecivityAD® test is based upon.

SILK™ Assay Publications

A randomized controlled study to evaluate the effect of bexarotene on amyloid-β and apolipoprotein E metabolism in healthy subjects.

Ghosal K, Haag M, Verghese PB, West T, Veenstra T, Braunstein JB, Bateman RJ, Holtzman DM, Landreth GE

Alzheimer's and Dementia 2(2): 110–120 (2016). (http://dx.doi.org/10.1016/j.trci.2016.06.001)

• Study measuring metabolism of both Aβ and ApoE in human CSF samples.

An antidepressant decreases CSF Aβ production in healthy individuals and in transgenic AD mice.

Sheline YI, West T, Yarasheski K, Swarm R, Jasielec MS, Fisher JR, Ficker WD, Yan P, Xiong C, Frederiksen C, Grzelak M V, Chott R, Bateman RJ, Morris JC, Mintun Ma, Lee J-M, Cirrito JR

Sci Transl Med 6:236re4 (2014). (https://doi.org/10.1126/scitranslmed.3008169)

• Study evaluating the effect of an antidepressant on Aβ metabolism.

Human amyloid-beta synthesis and clearance rates as measured in cerebrospinal fluid in vivo.

Bateman RJ, Munsell LY, Morris JC, Swarm R, Yarasheski KE, Holtzman DM

Nat Med 12:856–861 (2006). (http://doi.org/10.1038/nm1438)

• Initial description of the SILK™ Assay for measuring Aβ metabolism in human subjects.