ReviewMolecular therapy. Advances2026
AAV serotype IVDs for patient selection in gene therapy development: Technical and regulatory considerations by ARDAT consortium.
Review in Molecular therapy. Advances, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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12 authors.
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Abstract
Currently, most clinical trials for adeno-associated virus (AAV)-based gene therapy (GT) exclude patients with pre-existing anti-AAV antibodies (AAV Abs) due to potential impact on treatment efficacy and safety. Diagnostic regulations require sponsors to define pre-existing AAV Ab level cutoffs and validate patient selection assays before beginning clinical studies. In the absence of robust clinical outcome data early in development, sponsors often rely on thresholds derived from literature or preclinical studies, or default to assay detection limits. The transferability of these thresholds to actual clinical outcomes remains uncertain, leading sponsors to use conservative cutoffs to avoid costly revalidations and development delays. This may prevent some patients from accessing potentially beneficial treatments. We advocate for more flexible validation approaches based on current understanding of antibody characteristics and the commonly used assay formats. We propose an AAV serotype-specific
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