Lisamarie Collins

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Health care practitioners are more frequently using laboratory developed tests (LDTs) to diagnose and predict the risk of developing a disease, as well as to inform decisions on disease state management such as for cancer, heart disease and diabetes. As practitioners become increasingly reliant on diagnostic tests to guide important treatment decisions, concerns about the efficacy and safety of new LDTs have simultaneously arisen. As a result, regulatory safeguards that can ensure LDTs’ accuracy are…