NIH-Funded Grant: Regulatory Framework for Direct-to-Consumer Microbiome-Based Tests

In August 2019, Diane Hoffmann and co-investigators Dr. Frank Palumbo, Dr. Jacques Ravel, Dr. Mary-Claire Roghmann, and Dr. Erik von Rosenvinge were awarded an R01 grant from the National Human Genome Research Institute (NHGRI) to study the regulatory framework for direct-to-consumer (DTC) microbiome-based screening tests. These tests rely on genomic sequencing technology and are available to consumers without a provider prescription. The goal of this four-year grant is to inform regulatory approaches for DTC microbiome-based tests and to identify and address regulatory problems and gaps and encourage a balance between regulation and innovation in the microbiome-based testing industry.