2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA (PART 2A - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) PART 2B - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation)
2024 年生物分析最新议题白皮书：美国实验室自建检测 (LDT) 和欧盟体外诊断医疗器械法规 (IVDR) 的影响；高参数流式细胞术的 AI/ML；Olink 技术的崛起；腺相关病毒 (AAV) 基因疗法的伴随诊断 (CDx)；多平台整合生物分析；超灵敏 ADA/NAb 配体结合分析 (LBA)（第二部分 A - 生物标志物、体外诊断/伴随诊断检测 (BAV)、细胞检测 (CBA) 和配体结合分析 (LBA) 的高级策略建议；第二部分 B - 监管机构对生物标志物、体外诊断/伴随诊断和生物标志物检测验证的意见）
期刊:Bioanalysis
影响因子:1.8
doi:10.1080/17576180.2024.2442218
Bivi, Nicoletta; Graham, Danielle; Joglekar, Laura; McGuire, Kristina; Stoop, Jeroen; Zoghbi, Jad; Baker, Brian; Bandukwala, Abbas; Bond, Sarah; Buoninfante, Alessandra; Chen, Jeff; Dysinger, Mark; Engelbergs, Jörg; Fiscella, Michele; Garofolo, Fabio; Hopper, Shirley; Jones, Barry; King, Lindsay; Murphy, Rocio; Palmer, Rachel; Sanderink, Gerard; Seyda, Agnes; Tang, Huaping; Van Tuyl, Andrea; Wagner, Leslie; Walravens, Karl; Wang, Kai; Zander, Hilke; Zhu, Liang; Li, Ming; Lin, Yi-Dong; Natalia, Mahwish; Standifer, Nathan; Eck, Steven; Goihberg, Polina; Grugan, Katharine; Hedrick, Michael Nathan; Hopkins, Greg; Kar, Sumit; Keller, Steve; McGrath, Shannon; O'Gorman, Bill; Stevens, Chad; Stevens, Erin; Terszowski, Grzegorz; Trampont, Paul C; Yao, Shuyu; Joyce, Alison; Kumar, Seema; Owen, Carolina; Pine, Samuel; Yearwood, Graham; Cao, Liching; Clausen, Valerie; Coble, Kelly; Culbert, Andria; Gupta, Shalini; Hughes, Richard; Liu, Susana; Lu, Kun; Martello, Rita; Reese, Kimberly J; Stubenrauch, Kay-Gunnar; Wen, Yi
