Devices

MDIC Somatic Reference Samples Initiative

The Medical Device Information Consortium (MDIC) has launched its somatic reference samples (SRS) initiative with a pilot project to improve the validation and regulatory review process for cancer diagnostics based on next-generation sequencing (NGS). An MDIC release says the group is collaborating with FDA, the National Institute of Standards and Technology, the National Institutes of Health, and industry stakeholders to manufacture, validate, and distribute SRSs to simplify and support the validation of NGS-based cancer diagnostics.

“The initiative also includes the goal to create a publicly available global genomic data resource library of datasets with the potential to be used by sponsors and regulators,” the MDIC release says.

MDIC says its SRS project began as a working group in 2018 representing more than 40 stakeholders with a mission to address the gap in reference material for NGS-based diagnostic tests. The working group published MDIC’s SRS Landscape Analysis in 2019 as a comprehensive catalog of existing clinically relevant cancer variants and available reference samples. Based on unmet needs discovered through that analysis, the SRS Initiative has prioritized a subset of 10 variants to be engineered into reference samples for the pilot project, MDIC says.

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