日期:
2020 年 — 2026 年
2020
2021
2022
2023
2024
2025
2026
影响因子:

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

2025 年生物分析最新问题白皮书:生物标志物校准品和稳定性;核素标记免疫球蛋白结合免疫球蛋白 (NULISA) 的评估;神经丝和自身抗体生物标志物检测;消除 IgM 干扰;酶联免疫斑点 (ELISpot) 和荧光斑点 (FluoroSpot) 最佳实践;模块化高清流式细胞术;单细胞分析成像流式细胞术(第二部分 A - 关于生物标志物发现、开发、验证和监管审批、配体结合分析 (LBA) 和基于细胞的分析 (CBA) 的建议;第二部分 B - 监管机构对生物标志物、体外诊断/伴随诊断 (IVD/CDx) 的意见)

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

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)

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

Giroctocogene fitelparvovec gene therapy for severe hemophilia A: 104-week analysis of the phase 1/2 Alta study

用于治疗重度血友病A的Giroctocogene fitelparvovec基因疗法:1/2期Alta研究的104周分析

Leavitt, Andrew D; Konkle, Barbara A; Stine, Kimo C; Visweshwar, Nathan; Harrington, Thomas J; Giermasz, Adam; Arkin, Steven; Fang, Annie; Plonski, Frank; Yver, Anne; Ganne, Florence; Agathon, Delphine; Resa, Maria de Los Angeles; Tseng, Li-Jung; Di Russo, Gregory; Cockroft, Bettina M; Cao, Liching; Rupon, Jeremy

Patient-specific mutation of Dync1h1 in mice causes brain and behavioral deficits.

小鼠体内 Dync1h1 基因的特异性突变会导致大脑和行为缺陷。

Ramos Raddy L, De Heredia Maider Michelena Beltran, Zhang Yongwei, Stout Randy F, Tindi Jaafar O, Wu Liching, Schwartz Gary J, Botbol Yair M, Sidoli Simone, Poojari Ankita, Rakowski-Anderson Tammy, Shafit-Zagardo Bridget

Childhood-Onset ANCA-Associated Vasculitis: From Genetic Studies to Advances in Pathogenesis, Classification and Novel Therapeutic Approaches

儿童期发病的ANCA相关性血管炎:从遗传学研究到发病机制、分类和新型治疗方法的进展

Yeo, Liching; Naheed, Asma; Richards, Chantelle; Ciurtin, Coziana

A sensitive AAV transduction inhibition assay assists evaluation of critical factors for detection and concordance of pre-existing antibodies

灵敏的AAV转导抑制试验有助于评估检测和验证预存抗体的关键因素

Pan, Yonghua; Rohde, Michelle; Zeitler, Jennifer; Namburi, Sai Valli Srujana; Cao, Liching; Hu, Jing; Meyer, Kathleen; Lu, Yanmei

Clinical enrollment assay to detect preexisting neutralizing antibodies to AAV6 with demonstrated transgene expression in gene therapy trials

临床入组检测用于检测基因治疗试验中已证实存在针对AAV6转基因表达的中和抗体

Cao, Liching; Ledeboer, Annemarie; Pan, Yonghua; Lu, Yanmei; Meyer, Kathleen

First-in-human in vivo genome editing via AAV-zinc-finger nucleases for mucopolysaccharidosis I/II and hemophilia B

利用腺相关病毒(AAV)锌指核酸酶进行人体体内基因组编辑,首次用于治疗粘多糖贮积症I/II型和B型血友病

Harmatz, Paul; Prada, Carlos E; Burton, Barbara K; Lau, Heather; Kessler, Craig M; Cao, Liching; Falaleeva, Marina; Villegas, Andres G; Zeitler, Jennifer; Meyer, Kathleen; Miller, Weston; Wong Po Foo, Cheryl; Vaidya, Sagar; Swenson, Wendy; Shiue, Lisa H; Rouy, Didier; Muenzer, Joseph

AAV2/6 Gene Therapy in a Murine Model of Fabry Disease Results in Supraphysiological Enzyme Activity and Effective Substrate Reduction

AAV2/6 基因治疗法布里病小鼠模型可产生超生理酶活性并有效减少底物

Makiko Yasuda, Marshall W Huston, Silvere Pagant, Lin Gan, Susan St Martin, Scott Sproul, Daniel Richards, Stephen Ballaron, Khaled Hettini, Annemarie Ledeboer, Lillian Falese, Liching Cao, Yanmei Lu, Michael C Holmes, Kathleen Meyer, Robert J Desnick, Thomas Wechsler

Multimodal Analysis of Cell Types in a Hypothalamic Node Controlling Social Behavior

控制社会行为的下丘脑节点细胞类型的多模态分析

Dong-Wook Kim, Zizhen Yao, Lucas T Graybuck, Tae Kyung Kim, Thuc Nghi Nguyen, Kimberly A Smith, Olivia Fong, Lynn Yi, Noushin Koulena, Nico Pierson, Sheel Shah, Liching Lo, Allan-Hermann Pool, Yuki Oka, Lior Pachter, Long Cai, Bosiljka Tasic, Hongkui Zeng, David J Anderson