Next generation sequencing (NGS) data supporting resistance assessments is crucial to developing and gaining FDA clearance for new antiviral drugs and related companion diagnostic tests (CDx). Now the agency has issued a new Technical Specifications document (Tech Doc) telling sponsors they should use that data to support their products. What the Tech Doc Is All About Unlike conventional Sanger nucleotide sequence which measures viral resistance by providing an average sequence of the virus population, NGS provides nucleotide sequence information for individual viruses within a viral population, often generating millions or billions of short sequences per sample. The complexity of the data makes it hard for reviewers from the FDA’s Division of Antiviral Products to analyze and validate the sequence information. Adding to the challenge is the current lack of a standardized bioinformatics analysis approaches for analyzing such large datasets. The purpose of the Tech Doc is to explain to sponsors how to compile, analyze and submit NGS resistance assessment data so the Division can review it. The Tech Doc provides crucial guidance on six key issues. 1. Acceptable NGS Platforms The Tech Doc indicates that the Division will accept nucleotide sequencing data generated from most standard NGS platforms as long […]