Patients with preexisting antibodies to a gene therapy product are often excluded from treatment based on arbitrary cutoffs. Benefit-risk-based considerations and determination of clinically relevant cutoffs using a diagnostic assay, validated according to its intended use in adequate laboratories, could improve patient selection and their treatment.
All Keywords
【저자키워드】 Gene therapy, adeno-associated virus, patient selection, Preexisting antibodies, risk-benefit assessment, clinical decision limit, companion diagnostic, diagnostic assay strategy, in vitro diagnostic regulations, reference limit,
【저자키워드】 Gene therapy, adeno-associated virus, patient selection, Preexisting antibodies, risk-benefit assessment, clinical decision limit, companion diagnostic, diagnostic assay strategy, in vitro diagnostic regulations, reference limit,