2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A – Recommendations on Biomarkers Discovery, Development, Validation & Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B – Regulatory Agencies’ Input on Biomarkers, IVD/CDx and Biomarker Assay Validation (BAV))

Sarah Hersey, Kristina McGuire, Olga Kholmanskikh, Nicoletta Bivi, Abbas Bandukwala, Binsheng Gong, Chad Irwin, Soma Ray, Michele Gunsior, Andrei Avanesov, Brian Baker, Sarah Bond, Alexander Braun, Alessandra Buoninfante, Francis Dessy, Xiaodong Fang, Fabio Garofolo, Emily Gomme, Amanda Hays, Lindsay King, Christian Mayer, Jessica McGregor, Melis McHenry, Anna Nowocin, Carrie Rubel, Gerard Sanderink, Bradley Scott, Ingrid Scully, Agnes Seyda, Jeroen Stoop, Huaping Tang, Joao Tavares Neto, Karl Walravens, Kai Wang, Sarah Wassmer, Wenming Xiao, Liang Zhu, Jad Zoghbi, Catherine Brockus, Corinne Petit-Frere, Kelly Coble, Sally Fischer, Graham Yearwood, Liching Cao, Mark Dysinger, Christine Grimaldi, Yong Jiang, Alison Joyce, Claire Kerridge, Kun Lu, Fred McCush, Katrina Nolan, Ellen O’ Connor, Rachel Palmer, Kimberly Reese, Kay-Gunnar Stubenrauch, Thorsten Verch, Christopher Beaver, Luis Mendez, Vilma Decman, Kamala Bhavaraju, James Huleatt, Paul C Trampont, Steven Eck, Polina Goihberg, Enrique Gomez Alcaide, Michael Nathan Hedrick, Rashmi Jalah, Shannon McGrath, William Ogorman, Sandra Prior, Sarita Sehra, Saleem Shaik, Nathan Standifer, Chad Stevens, Erin Stevens, Yongliang (Steve) Sun

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DOI: 10.1080/17576180.2025.2599698
Published: 2025-12-02
Container: Bioanalysis
Publisher: Informa UK Limited
Open access: unknown

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Cite this work

BibTeX

@article{allodium:10.1080/17576180.2025.2599698,
  title = {2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators \&amp; Stability; Evaluation of NULISA; Neurofilament \&amp; Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot \&amp; FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A – Recommendations on Biomarkers Discovery, Development, Validation \&amp; Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B – Regulatory Agencies’ Input on Biomarkers, IVD/CDx and Biomarker Assay Validation (BAV))},
  author = {Sarah Hersey and Kristina McGuire and Olga Kholmanskikh and Nicoletta Bivi and Abbas Bandukwala and Binsheng Gong and Chad Irwin and Soma Ray and Michele Gunsior and Andrei Avanesov and Brian Baker and Sarah Bond and Alexander Braun and Alessandra Buoninfante and Francis Dessy and Xiaodong Fang and Fabio Garofolo and Emily Gomme and Amanda Hays and Lindsay King and Christian Mayer and Jessica McGregor and Melis McHenry and Anna Nowocin and Carrie Rubel and Gerard Sanderink and Bradley Scott and Ingrid Scully and Agnes Seyda and Jeroen Stoop and Huaping Tang and Joao Tavares Neto and Karl Walravens and Kai Wang and Sarah Wassmer and Wenming Xiao and Liang Zhu and Jad Zoghbi and Catherine Brockus and Corinne Petit-Frere and Kelly Coble and Sally Fischer and Graham Yearwood and Liching Cao and Mark Dysinger and Christine Grimaldi and Yong Jiang and Alison Joyce and Claire Kerridge and Kun Lu and Fred McCush and Katrina Nolan and Ellen O’ Connor and Rachel Palmer and Kimberly Reese and Kay-Gunnar Stubenrauch and Thorsten Verch and Christopher Beaver and Luis Mendez and Vilma Decman and Kamala Bhavaraju and James Huleatt and Paul C Trampont and Steven Eck and Polina Goihberg and Enrique Gomez Alcaide and Michael Nathan Hedrick and Rashmi Jalah and Shannon McGrath and William Ogorman and Sandra Prior and Sarita Sehra and Saleem Shaik and Nathan Standifer and Chad Stevens and Erin Stevens and Yongliang (Steve) Sun},
  year = {2025},
  journal = {Bioanalysis},
  doi = {10.1080/17576180.2025.2599698},
  url = {https://doi.org/10.1080/17576180.2025.2599698}
}

RIS

TY  - JOUR
TI  - 2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators &amp; Stability; Evaluation of NULISA; Neurofilament &amp; Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot &amp; FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A – Recommendations on Biomarkers Discovery, Development, Validation &amp; Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B – Regulatory Agencies’ Input on Biomarkers, IVD/CDx and Biomarker Assay Validation (BAV))
AU  - Sarah Hersey
AU  - Kristina McGuire
AU  - Olga Kholmanskikh
AU  - Nicoletta Bivi
AU  - Abbas Bandukwala
AU  - Binsheng Gong
AU  - Chad Irwin
AU  - Soma Ray
AU  - Michele Gunsior
AU  - Andrei Avanesov
AU  - Brian Baker
AU  - Sarah Bond
AU  - Alexander Braun
AU  - Alessandra Buoninfante
AU  - Francis Dessy
AU  - Xiaodong Fang
AU  - Fabio Garofolo
AU  - Emily Gomme
AU  - Amanda Hays
AU  - Lindsay King
AU  - Christian Mayer
AU  - Jessica McGregor
AU  - Melis McHenry
AU  - Anna Nowocin
AU  - Carrie Rubel
AU  - Gerard Sanderink
AU  - Bradley Scott
AU  - Ingrid Scully
AU  - Agnes Seyda
AU  - Jeroen Stoop
AU  - Huaping Tang
AU  - Joao Tavares Neto
AU  - Karl Walravens
AU  - Kai Wang
AU  - Sarah Wassmer
AU  - Wenming Xiao
AU  - Liang Zhu
AU  - Jad Zoghbi
AU  - Catherine Brockus
AU  - Corinne Petit-Frere
AU  - Kelly Coble
AU  - Sally Fischer
AU  - Graham Yearwood
AU  - Liching Cao
AU  - Mark Dysinger
AU  - Christine Grimaldi
AU  - Yong Jiang
AU  - Alison Joyce
AU  - Claire Kerridge
AU  - Kun Lu
AU  - Fred McCush
AU  - Katrina Nolan
AU  - Ellen O’ Connor
AU  - Rachel Palmer
AU  - Kimberly Reese
AU  - Kay-Gunnar Stubenrauch
AU  - Thorsten Verch
AU  - Christopher Beaver
AU  - Luis Mendez
AU  - Vilma Decman
AU  - Kamala Bhavaraju
AU  - James Huleatt
AU  - Paul C Trampont
AU  - Steven Eck
AU  - Polina Goihberg
AU  - Enrique Gomez Alcaide
AU  - Michael Nathan Hedrick
AU  - Rashmi Jalah
AU  - Shannon McGrath
AU  - William Ogorman
AU  - Sandra Prior
AU  - Sarita Sehra
AU  - Saleem Shaik
AU  - Nathan Standifer
AU  - Chad Stevens
AU  - Erin Stevens
AU  - Yongliang (Steve) Sun
PY  - 2025
JO  - Bioanalysis
DO  - 10.1080/17576180.2025.2599698
UR  - https://doi.org/10.1080/17576180.2025.2599698
ER  -

APA

Hersey, S., McGuire, K., Kholmanskikh, O., Bivi, N., Bandukwala, A., Gong, B., Irwin, C., Ray, S., Gunsior, M., Avanesov, A., Baker, B., Bond, S., Braun, A., Buoninfante, A., Dessy, F., Fang, X., Garofolo, F., Gomme, E., Hays, A., King, L., Mayer, C., McGregor, J., McHenry, M., Nowocin, A., Rubel, C., Sanderink, G., Scott, B., Scully, I., Seyda, A., Stoop, J., Tang, H., Neto, J. T., Walravens, K., Wang, K., Wassmer, S., Xiao, W., Zhu, L., Zoghbi, J., Brockus, C., Petit-Frere, C., Coble, K., Fischer, S., Yearwood, G., Cao, L., Dysinger, M., Grimaldi, C., Jiang, Y., Joyce, A., Kerridge, C., Lu, K., McCush, F., Nolan, K., Connor, E. O., Palmer, R., Reese, K., Stubenrauch, K., Verch, T., Beaver, C., Mendez, L., Decman, V., Bhavaraju, K., Huleatt, J., Trampont, P. C., Eck, S., Goihberg, P., Alcaide, E. G., Hedrick, M. N., Jalah, R., McGrath, S., Ogorman, W., Prior, S., Sehra, S., Shaik, S., Standifer, N., Stevens, C., Stevens, E., & Sun, Y. (. (2025). 2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A – Recommendations on Biomarkers Discovery, Development, Validation & Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B – Regulatory Agencies’ Input on Biomarkers, IVD/CDx and Biomarker Assay Validation (BAV)). Bioanalysis. https://doi.org/10.1080/17576180.2025.2599698

Source records

crossref · retrieved 2026-09-26T01:04:59.749Z