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Bringing Greater Accuracy to Europe's Healthcare Systems: The Unexploited Potential of Biomarker Testing in Oncology.
Horgan D, Ciliberto G, Conte P, Baldwin D, Seijo L, Montuenga LM, Paz-Ares L, Garassino M, Penault-Llorca F, Galli F, Ray-Coquard I, Querleu D, Capoluongo E, Banerjee S, Riegman P, Kerr K, Horbach B, Büttner R, Van Poppel H, Bjartell A, Codacci-Pisanelli G, Westphalen B, Calvo F, Koeva-Balabanova J, Hall S, Paradiso A, Kalra D, Cobbaert C, Varea Menendez R, Maravic Z, Fotaki V, Bennouna J, Cauchin E, Malats N, Gutiérrez-Ibarluzea I, Gannon B, Mastris K, Bernini C, Gallagher W, Buglioni S, Kent A, Munzone E, Belina I, Van Meerbeeck J, Duffy M, Sarnowska E, Jagielska B, Mee S, Curigliano G. Horgan D, et al. Among authors: cobbaert c. Biomed Hub. 2020 Sep 14;5(3):182-223. doi: 10.1159/000511209. eCollection 2020 Sep-Dec. Biomed Hub. 2020. PMID: 33564664 Free PMC article.
ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics Regulation.
Vanstapel FJLA, Orth M, Streichert T, Capoluongo ED, Oosterhuis WP, Çubukçu HC, Bernabeu-Andreu FA, Thelen M, Jacobs LHJ, Linko S, Bhattoa HP, Bossuyt PMM, Meško Brguljan P, Boursier G, Cobbaert CM, Neumaier M. Vanstapel FJLA, et al. Clin Chem Lab Med. 2023 Jan 31;61(4):608-626. doi: 10.1515/cclm-2023-0045. Print 2023 Mar 28. Clin Chem Lab Med. 2023. PMID: 36716120 Free article. Review.
Critical Implications of IVDR for Innovation in Diagnostics: Input From the BioMed Alliance Diagnostics Task Force.
Dombrink I, Lubbers BR, Simulescu L, Doeswijk R, Tkachenko O, Dequeker E, Fraser AG, van Dongen JJM, Cobbaert C, Brüggemann M, Macintyre E. Dombrink I, et al. Among authors: cobbaert c. Hemasphere. 2022 May 20;6(6):e724. doi: 10.1097/HS9.0000000000000724. eCollection 2022 Jun. Hemasphere. 2022. PMID: 35620593 Free PMC article. No abstract available.
233 results