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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).
Bivi N, Graham D, Joglekar L, McGuire K, Stoop J, Zoghbi J, Baker B, Bandukwala A, Bond S, Buoninfante A, Chen J, Dysinger M, Engelbergs J, Fiscella M, Garofolo F, Hopper S, Jones B, King L, Murphy R, Palmer R, Sanderink G, Seyda A, Tang H, Van Tuyl A, Wagner L, Walravens K, Wang K, Zander H, Zhu L, Li M, Lin YD, Natalia M, Standifer N, Eck S, Goihberg P, Grugan K, Hedrick MN, Hopkins G, Kar S, Keller S, McGrath S, O'Gorman B, Stevens C, Stevens E, Terszowski G, Trampont PC, Yao S, Joyce A, Kumar S, Owen C, Pine S, Yearwood G, Cao L, Clausen V, Coble K, Culbert A, Gupta S, Hughes R, Liu S, Lu K, Martello R, Reese KJ, Stubenrauch KG, Wen Y. Bivi N, et al. Among authors: stoop j. Bioanalysis. 2025 Jan 25:1-38. doi: 10.1080/17576180.2024.2442218. Online ahead of print. Bioanalysis. 2025. PMID: 39862107
Evaluation of waning of IgG antibody responses after rVSVΔG-ZEBOV-GP and Ad26.ZEBOV, MVA-BN-Filo Ebola virus disease vaccines: a modelling study from the PREVAC randomized trial.
Valayer S, Alexandre M, Prague M, Beavogui AH, Doumbia S, Kieh M, Greenwood B, Leigh B, Poupelin M, Schwimmer C, Sow SO, Berry IM, Kuhn JH, Fusco D, Cauwelaert ND, Watson-Jones D, Thiébaut R, Lévy Y, Yazdanpanah Y, Richert L, Lhomme E; PREVAC Study Team; Aboulhab J, Aguirre-MacKenzie M BS, Akoo P MB, ChB, Akpa E MSN, MPH, RN, Akpata R, Albert S BA, MPH, Ale BM MD, MSc, MPH, Alimamy-Bangura S MB, ChB, Andong P MSt, Andrews BC, Anoma S, Atri N MPH, CPH, Augier A MCom, Awuondo K MSc, Ayouba A, Badio M MSc, Bagayoko A, Balde A MPH, Balssa J PharmD, Bangura LM BSc, Barrington K MPA, Barte de Saint Fare E BA, Baseler B MS, Bauder A BA, PMP, Bauduin C MSc, Bawo L MSc, Beavogui AH MD, PhD, Belson M BS, Ben-Farhat S MEng, Bererd M BS, Bernaud N MSc, Beyslow T PharmD, Biai N MSc, Billioux J, Billouin-Frazier S MSc, Binachon B MD, MPH, Blie J MSc, Bockstal V, Boison P MS, Bolay F, Boly A MM, Bonawitz RE MD, MS, Borg AG MCM, Bosompem S PharmD, MSc, Bozman C MSc, Brady T MPH, Browne S RN, BSN, Bullis R, Cagniard B, Cahill K RN, MSc, CCRC, RAC, Cai Y, Camara AA MSc, Camara AK, Camara AM, Campagne A, Campion C MSc, Cantan A BSc, Cash J BS, Chai SP BBio-MedSc, Chambelin F MHist, Chea M BSc, Chêne… See abstract for full author list ➔ Valayer S, et al. Among authors: stoop j. Emerg Microbes Infect. 2025 Dec;14(1):2432353. doi: 10.1080/22221751.2024.2432353. Epub 2024 Dec 9. Emerg Microbes Infect. 2025. PMID: 39559990 Free PMC article. Clinical Trial.
Harmonization of Vaccine Ligand Binding Assays Validation.
Dessy F, Sonderegger I, Wagner L, Buoninfante A, Wadhwa M, Agnes J, Aksyuk A, Baclin A, Bonhomme M, Cloney-Clark S, Corsaro B, Neto JT, Fries L, Gagnon L, Garofolo F, Giardina P, Green T, Guimera N, Harris S, Helmy R, Huleatt J, Ishii-Watabe A, Jaeger R, Jani D, Janssen S, Kierstead L, Makar K, Marshall JC, Mayer C, Mendes DN, Murphy R, Nadarajah S, Nolan K, Plested J, Scully I, Solstad T, Stoop J, Tan C, Verch T, Wilkins D, Xu A, Zheng L, Zhu M. Dessy F, et al. Among authors: stoop j. Bioanalysis. 2024;16(19-20):1067-1091. doi: 10.1080/17576180.2024.2411925. Epub 2024 Nov 14. Bioanalysis. 2024. PMID: 39540375
Long-term cellular immunity of vaccines for Zaire Ebola Virus Diseases.
Wiedemann A, Lhomme E, Huchon M, Foucat E, Bérerd-Camara M, Guillaumat L, Yaradouno M, Tambalou J, Rodrigues C, Ribeiro A, Béavogui AH, Lacabaratz C, Thiébaut R, Richert L, Lévy Y; Prevac study team. Wiedemann A, et al. Nat Commun. 2024 Sep 3;15(1):7666. doi: 10.1038/s41467-024-51453-z. Nat Commun. 2024. PMID: 39227399 Free PMC article. Clinical Trial.
Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO®): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults.
Lee AW, Liu K, Lhomme E, Blie J, McCullough J, Onorato MT, Connor L, Simon JK, Dubey S, VanRheenen S, Deutsch J, Owens A, Morgan A, Welebob C, Hyatt D, Nair S, Hamzé B, Guindo O, Sow SO, Beavogui AH, Leigh B, Samai M, Akoo P, Serry-Bangura A, Fleck S, Secka F, Lowe B, Watson-Jones D, Roy C, Hensley LE, Kieh M, Coller BG; PREVAC Study Team. Lee AW, et al. Clin Infect Dis. 2024 Apr 10;78(4):870-879. doi: 10.1093/cid/ciad693. Clin Infect Dis. 2024. PMID: 37967326 Free PMC article. Clinical Trial.
2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
Sumner G, Keller S, Huleatt J, Staack RF, Wagner L, Azadeh M, Bandukwala A, Cao L, Du X, Salinas GF, Garofolo F, Harris S, Hopper S, Irwin C, Ji Q, Joseph J, King L, Kinhikar A, Lu Y, Luo R, Mabrouk O, Malvaux L, Marshall JC, McGuire K, Mikol V, Neely R, Qiu X, Saito Y, Salaun B, Scully I, Smeraglia J, Solstad T, Stoop J, Tang H, Teixeira P, Wang Y, Wright M, Mendez L, Beaver C, Eacret J, Au-Yeung A, Decman V, Dessy F, Eck S, Goihberg P, Alcaide EG, Gonneau C, Grugan K, Hedrick MN, Kar S, Sehra S, Stevens E, Stevens C, Sun Y, McCush F, Williams L, Fischer S, Wu B, Jordan G, Burns C, Cludts I, Coble K, Grimaldi C, Henderson N, Joyce A, Lotz G, Lu Y, Luo L, Neff F, Sperinde G, Stubenrauch KG, Wang Y, Ware M, Xu W. Sumner G, et al. Among authors: stoop j. Bioanalysis. 2023 Aug;15(15):861-903. doi: 10.4155/bio-2023-0151. Epub 2023 Aug 16. Bioanalysis. 2023. PMID: 37584363
163 results