MDICx: Clinical Dx Somatic Reference Samples Landscape Analysis
The Landscape Analysis report was created from the work conducted by the Somatic Reference Sample initiative. The Landscape Analysis sub-group has multiple stakeholders including reference sample manufacturers, regulatory agencies, validation study leaders, and end users of reference samples. The Landscape Analysis subgroup was charged with conducting a thorough analysis of projects related to NGS reference samples to a) avoid duplicative efforts; b) identify gaps where the desired optimum reference samples are not yet developed or available; and c) help define specific gaps and unmet needs with respect to, for example, sample type(s), genes, variants, and so forth.
This report contains a comprehensive summary identifying other efforts for development and evaluation of NGS reference samples which may inform and complement the SRS goals. It is provided here for the use of the diagnostic testing community for a variety of applications, including (but not limited to) assay development, test validation, and quality control.
When the report was being compiled for use by the working committee, several members indicated that the report should be made available for public use as it would be a valuable resource for research.
- Timothy T. Stenzel, MD, PhD, Director of In Vitro Diagnostics (IVD) and Radiological Health (OIR), Center for Devices and Radiological Health, Food and Drug Administration (FDA)
- Zivana Tezak, PhD, Associate Director for Science and Technology, Office of In Vitro DiagnosticsRadiological Health (OIR), Center for Devices and Radiological Health, Food and Drug Administration (FDA)
- Barbara Zehnbauer, PhD, FACMG, Adjunct Professor of Pathology at the Emory School of Medicine | SPOT/Dx Steering Committee Chair and MDIC Clinical Dx Somatic Reference Samples Landscape Analysis Sub-group Chair
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