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The Food and Drug Administration (FDA) and Center for Biologics Evaluation and Research (CBER) define an IVD as: “In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae
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EC subtypes involve mutations in AT-Rich Interaction Domain 1A (ARID1A), Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PI3KCA), Phosphatase And Tensin Homolog (PTEN), Protein Phosphatase 2 Scaffold Subunit Alpha (PPP2R1α), and mismatch repair deficiency
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