Preexisting antibody assays for gene therapy: Considerations on patient selection cutoffs and companion diagnostic requirements.
adeno-associated virus
clinical decision limit
companion diagnostic
diagnostic assay strategy
gene therapy
in vitro diagnostic regulations
patient selection
preexisting antibodies
reference limit
risk-benefit assessment
Journal
Molecular therapy. Methods & clinical development
ISSN: 2329-0501
Titre abrégé: Mol Ther Methods Clin Dev
Pays: United States
ID NLM: 101624857
Informations de publication
Date de publication:
14 Mar 2024
14 Mar 2024
Historique:
medline:
18
3
2024
pubmed:
18
3
2024
entrez:
18
3
2024
Statut:
epublish
Résumé
Recombinant adeno-associated virus (AAV) vectors are the leading delivery vehicle used for
Identifiants
pubmed: 38496304
doi: 10.1016/j.omtm.2024.101217
pii: S2329-0501(24)00033-0
pmc: PMC10944107
doi:
Types de publication
Journal Article
Review
Langues
eng
Pagination
101217Informations de copyright
© 2024 The Author(s).
Déclaration de conflit d'intérêts
The authors are employed by and receive compensation from companies that are involved in development of gene therapy modality therapeutics and are listed on the title page of the manuscript. The authors have no other relevant affiliations or financial involvements with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript. The views and conclusion presented in this paper are those of the authors and do not necessarily reflect the representative affiliation or company’s position on the subject.