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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).

Nicoletta Bivi, Danielle Graham, Laura Joglekar,Kristina McGuire,Jeroen Stoop,Jad Zoghbi, Brian Baker,Abbas Bandukwala, Sarah Bond, Alessandra Buoninfante, Jeff Chen,Mark Dysinger,Jörg Engelbergs,Michele Fiscella,Fabio Garofolo,Shirley Hopper,Barry Jones,Lindsay King,Rocio Murphy,Rachel Palmer, Gerard Sanderink, Agnes Seyda,Huaping Tang, Andrea Van Tuyl,Leslie Wagner,Karl Walravens, Kai Wang,Hilke Zander, Liang Zhu, Ming Li,Yi-Dong Lin, Mahwish Natalia,Nathan Standifer,Steven Eck,Polina Goihberg,Katharine Grugan,Michael Nathan Hedrick, Greg Hopkins,Sumit Kar,Steve Keller, Shannon McGrath, Bill O'Gorman,Chad Stevens,Erin Stevens, Grzegorz Terszowski,Paul C Trampont, Shuyu Yao,Alison Joyce,Seema Kumar, Carolina Owen,Samuel Pine, Graham Yearwood,Liching Cao,Valerie Clausen,Kelly Coble, Andria Culbert,Shalini Gupta, Richard Hughes,Susana Liu, Kun Lu, Rita Martello, Kimberly J Reese,Kay-Gunnar Stubenrauch, Yi Wen

Bioanalysis（2025）

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