A call to adapt the regulation of HLA testing for T cell receptor-based therapeutics: comment

Current regulation of T cell receptor (TCR)-based therapeutics may require repeated testing of patients for specific HLA alleles as well as companion diagnostics development, despite the invariant nature of the HLA genotype and availability of robust clinical HLA tests. This increases the burden on...

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Main Authors: Meyer, Miriam (Author) , Mahr, Andrea (Author) , Brewer, Joanna (Author) , Daniel, Volker (Author) , Dell‘Aringa, Justine (Author) , Goldstone, Tony (Author) , Hersey, Sarah (Author) , Johnston, Ian (Author) , Larson, Pamela (Author) , Loveridge, Michael (Author) , MacBeath, Gavin (Author) , Moyer, Mark (Author) , Nagorsen, Dirk (Author) , Papa, Sophie (Author) , Peiser, Leanne (Author) , Ranade, Koustubh (Author) , Rizzi, Ruben (Author) , Roers, Axel (Author) , Schendel, Dolores (Author) , Sivakumar, Pallavur (Author) , Tran, Eric (Author) , Türeci, Özlem (Author) , Weigand, Luise (Author) , Wennborg, Anders (Author) , Williams, Dennis (Author) , Yee, Cassian (Author) , Britten, Cedrik Michael (Author)
Format: Article (Journal) Editorial
Language:English
Published: 29 November 2023
In: Nature reviews. Drug discovery
Year: 2024, Volume: 23, Issue: 1, Pages: 1-2
ISSN:1474-1784
DOI:10.1038/d41573-023-00189-4
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1038/d41573-023-00189-4
Verlag, lizenzpflichtig, Volltext: https://www.nature.com/articles/d41573-023-00189-4
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Author Notes:Miriam Meyer, Andrea Mahr, Joanna Brewer, Volker Daniel, Justine Dell‘Aringa, Tony Goldstone, Sarah Hersey, Ian Johnston, Pamela Larson, Michael Loveridge, Gavin MacBeath, Mark Moyer, Dirk Nagorsen, Sophie Papa, Leanne Peiser, Koustubh Ranade, Ruben Rizzi, Axel Roers, Dolores Schendel, Pallavur Sivakumar, Eric Tran, Özlem Türeci, Luise Weigand, Anders Wennborg, Dennis Williams, Cassian Yee & Cedrik M. Britten
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Summary:Current regulation of T cell receptor (TCR)-based therapeutics may require repeated testing of patients for specific HLA alleles as well as companion diagnostics development, despite the invariant nature of the HLA genotype and availability of robust clinical HLA tests. This increases the burden on patients and the organizations developing these products. We propose regulatory flexibility to facilitate the development of and access to TCR-based therapeutics.
Item Description:Gesehen am 05.11.2024
Physical Description:Online Resource
ISSN:1474-1784
DOI:10.1038/d41573-023-00189-4