Chris Cain, Associate Editor, and Kai-Jye Lou, Senior Writer
RNA sequencing standardized
The FDA has convened a consortium to review the status of RNA sequencing for drug development and outline hurdles for incorporating the technology into the standard pharmacogenomics toolbox.1-4 The consortium concluded that although RNA sequencing still cannot give reliable absolute measurements of RNA, the data collected provide a baseline for assessing the value of new developments and can help drive the creation of regulatory standards and guidelines for use of RNA sequencing.
In 2005, the agency released its first guidance for pharmacogenomic data submissions, which provided a framework for evaluating protocols and data submitted with IND, NDA or BLA applications. In 2007, the FDA published a companion guidance detailing requirements for submission of differential gene expression data.
Since then, transcriptome profiling technologies have evolved substantially, and deep RNA sequencing (RNA-seq) has emerged as an alternative to the two established technologies for differential gene expression analysis-quantitative PCR (qPCR) and microarrays-owing to its increased detection sensitivity and its large dynamic range.
The Sequencing Quality Control (SEQC)/MicroArray Quality Control III (MAQC-III) consortium, organized under the auspices of the FDA, comprised academic and industry representatives and performed a multisite and cross-platform analysis