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NGS has revolutionized how IVD developers, laboratories, and clinicians are diagnosing, treating, and monitoring disease. NGS assays must be proven robust, accurate and consistent through validation and verification studies. Sourcing individual FFPE samples (remnant patient specimens or cell line derived for each of the somatic mutations of interest is expensive and time consuming. Materials with copy number variations (CNV) quantitatively characterized in a stable background have not been available. Therefore, highly multiplexed, engineered reference materials in FFPE format are needed.

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