USA – MDIC Works to Standardize Oversight of NGS-based Assays

To advance the regulatory science of diagnostic testing and assay development, the Medical Device Innovation Consortium (MDIC) posted a new landscape analysis report Wednesday to provide a snapshot of all known projects related to next-generation-sequencing (NGS) reference samples.

The landscape analysis report serves as a catalog of information on 35 projects marked as either completed, ongoing or under development. Projects were divided into five categories—synthetic DNA, genomic DNA, cell-free DNA, human cell lines and formalin-fixed paraffin embedded. The report is the product of the first of six subgroups formed at the US Food and Drug Administration (FDA) last year under the MDIC cancer genomic somatic reference samples (SRS) project.

The SRS landscape analysis subgroup was tasked with providing an overview of projects to help avoid duplicative efforts in the space by identifying existing NGS reference samples, genes/variants and sample types, as well as to define unmet needs for additional genes/variants and inform other SRS subgroup efforts. It received input from a wide range of stakeholders, including the College of American Pathologists, the American Association of Cancer Research, FDA and the Centers for Medicare and Medicaid Services, among others.

The report, which includes links to more detailed information on each project, is intended for active laboratories and testing facilities, regulators, diagnostic manufacturers and end users…