2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines ( PART 2 – Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies)

• Published in: Bioanalysis 2024, Vol.16 (8), p.179-220
• Main Authors: Kholmanskikh, Olga, Wang, Yow-Ming, Hersey, Sarah, Wadhwa, Meenu, Block, Katherine, Bandukwala, Abbas, Szapacs, Matthew, Weiner, Russell, Awwad, Khader, Dessy, Francis, Downing, Sean, Du, Xiulian, Garofolo, Fabio, Harris, Shannon, Hou, Victor, Jones, Jennifer, Kar, Sumit, Kinhikar, Arvind, Li, Ming, Mathews, Joel, Meissen, John, Sumner, Giane Oliveira, Pan, Luying, Sanderink, Gerard, Scully, Ingrid, Stanta, Johannes, Tanaka, Yoichi, Vauleon, Stephanie, Wagner, Leslie, Wang, Kai, Zhu, Liang, Eck, Steven, Lin, Yi-Dong, Azadeh, Mitra, Decman, Vilma, Diebold, Sandra, Goihberg, Polina, Alcaide, Enrique Gomez, Gonneau, Christele, Hedrick, Michael Nathan, Hopkins, Gregory, Loschko, Jakob, McCausland, Megan, Mendez, Luis, Sehra, Sarita, Stevens, Erin, Sun, Yongliang Steve, Tangri, Shabnam, Trampont, Paul C, Cludts, Isabelle, Dysinger, Mark, Kavita, Uma, Sugimoto, Hiroshi, Chilewski, Shannon, Grimaldi, Christine, Jiang, Yong, Kamerud, John, Liu, Susana, Owen, Carolina, Palackal, Nisha, Petit-frere, Corinne, Pine, Samuel, Abhari, Mohsen Rajabi, Scheibner, Kara, Williams, LaKenya, Xu, Tao, Zhang, Guodong
• Format: Article
• Language: English
• ISSN: 1757-6180; 1757-6199
• DOI: 10.1080/17576180.2024.2340961