Recommendations on biomarker assay validation (BAV) in tissues by GCC
Biomarker analysis enables a deep understanding of physiological and biological processes and offers insights into pathological disease states and conditions. When measured in tissues, the spatial distribution of biomarkers may be evaluated. To meet regulatory and sponsor requirements, guidance on the approach to validation and the parameters to be evaluated is essential. The main goals of this GCC white paper are to disseminate the survey results discussed during the 16<sup>th</sup>& 17<sup>th</sup>GCC Closed Forums (2023 & 2024) and to provide recommendations from the GCC members on technical and regulatory considerations for the bioanalysis of biomarkers in tissues.
Authors
- Allan Xu
- Tracy Iles
- Mark Odell (ORCID: https://orcid.org/0000-0001-5464-9882)
- Stephen E. Rundlett
- Cheikh Kane
- Nathan Riccitelli
- A. Iordăchescu (ORCID: https://orcid.org/0000-0001-5372-3614)
- Brian Hoffpauir
- Ritankar Majumdar (ORCID: https://orcid.org/0000-0001-6624-0187)
- Chantal Di Marco
- Weihua Gu (ORCID: https://orcid.org/0000-0003-3848-4840)
- Danielle Salha
- Stephen Lowes
- Manisha R. Diaz
- Jenny Lin
- Dominic Warrino
- Kelly Dong (ORCID: https://orcid.org/0000-0001-6349-4042)
- Katherine R. O’Brien (ORCID: https://orcid.org/0000-0001-8972-9161)
- John Pirro
- Vimal Patel
- Bin Xu (ORCID: https://orcid.org/0000-0002-1294-4506)
- Annika Carlsson
- Todd Lester
- Xinping Fang
- Wei Garofolo
- Marsha Luna
- Shane Karnik (ORCID: https://orcid.org/0000-0001-7019-7724)
- Dawn Dufield
- G. Reynolds (ORCID: https://orcid.org/0000-0003-2813-568X)
- Tim Sangster
- Mathilde Yu
- Troy Voelker
- Kurt Sales
- Martin Roberge
- Hollie Barton
- Jessica McGregor
- Naveen Dakappagari
- Magdalena Tary‐Lehmann
- David E Ambrose
- Mitesh Sanghvi
- Kevin Malone (ORCID: https://orcid.org/0000-0001-5665-4706)
- Jerome Bergeron
- Jim Yamashita
- Katie Matys
- Amy Lavelle
- Rathna Veeramachaneni
- Adriane Spytko
- Mohammed Bouhajib
- Robert Kernstock
- Jennifer Zimmer
- Michael Brown (ORCID: https://orcid.org/0000-0003-3230-401X)
- Amanda Hays (ORCID: https://orcid.org/0000-0002-3429-4727)
- Agostinho G. Rocha (ORCID: https://orcid.org/0000-0001-7134-7376)
- Mario Pellerin
- Shashank Gorityala
- Elizabeth Hyer
- Jia Liu
- Aihua Liu (ORCID: https://orcid.org/0000-0003-0309-114X)
- Vivek Kumar Dwivedi (ORCID: https://orcid.org/0009-0005-8603-3640)
- Moucun Yuan (ORCID: https://orcid.org/0000-0001-7532-1296)
- Tao Xu
- Annelies W. Turksma
- E Thomas
- Daniel J. Sikkema
- Iain Love
- Amanda Leskovar
- Elizabeth Dompkowski
Institutions
- Fordham University (US)
- WuXi AppTec (China) (CN)
- LabCorp (United States) (US)
- IQVIA (United Kingdom) (GB)
- Sanquin (NL)
- Thermo Fisher Scientific (Sweden) (SE)
- Novartis (France) (FR)
- Bioanalytica (Switzerland) (CH)
- The Institute of Conservation (GB)
- Charles River Laboratories (United Kingdom) (GB)
- Syneos Health (United States) (US)
- Altasciences (Canada) (CA)
- Precision for Medicine (United States) (US)
- Charles River Laboratories (United States) (US)
- Pharma Medica Research (Canada) (CA)
- Eurofins (Denmark) (DK)
- Green Communities Canada (CA)
- BioHybrid Solutions (United States) (US)
- BioPharm (United Kingdom) (GB)
- Royal Canadian Military Institute (CA)
- Vifor Pharma (United States) (US)
- Virbac (France) (FR)
- University of Colorado Colorado Springs (US)
Publication Details
- Journal
- Bioanalysis
- Published
- 2025-04-03
- DOI
- https://doi.org/10.1080/17576180.2025.2471243
- Citations
- 1
- Primary Topic
- Biosimilars and Bioanalytical Methods
- Type
- article
- Field-Weighted Citation Impact
- 0.80