Customer Story Optimizing Diagnostic Development Through Applied Statistical Techniques Finding clinical applications for basic research is a key priority in both the public and private sectors, driving the development of new diag- nostic tools for clinical use. Many factors affect the ability of researchers to get novel diagnostic products to market; in the US, the Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) regulate diagnostic tests, based on the intended use. Researchers seeking approval for their diagnostic tests must comply with evolving requirements for statistical analysis from these regulatory bodies, and diagnostic teams must evolve alongside these regulations to integrate robust statistical analysis into their research. Thus

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