Next-Generation Sequencing Applications for Antiviral Drug Development & FDA Guidance for Data Submission

Accurate detection and monitoring of minority variants that confer drug and antiviral resistance is critical to therapeutic and vaccine trials. Specifically, it aids in controlling the emergence of novel variants that can potentially lead to outbreaks of disease and breakthrough infections. Gene variants can compromise virologic response and impact clinical outcomes. In this webinar the featured speaker explores the following case study: Viracor Biopharma Services has developed and validated a next-generation sequencing (NGS) assay to determine the genetic variability in the F gene of respiratory syncytial virus (RSV) isolated from human nasal swab (NS) specimens. The NGS method has several advantages over standard Sanger sequencing related to higher sensitivity, quantifiable, cost effective and automatable data analysis steps. The study utilized a deep sequencing approach to quantify minority variants. The patients in this study received a therapeutic targeting RSV. Defined proportions of artificial virus quasispecies were used in creation of artificial RNA pools, and their relative proportions were measured using the NGS assay. The assay was validated for the performance characteristics such as analytical sensitivity, precision and accuracy.

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