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Diagnostics for Infectious Diseases in Resource-limited Settings: The Pathway from Product to Implementation
March 3 @ 4:00 pm - 5:30 pm
Diagnostics Grand Rounds brings clinicians with unmet needs to the Wyss Institute. The goal of these sessions is to inform technology developers about important clinical problems that can help them direct their technology development efforts. Presenters are asked to identify diagnostic needs that will have an impact on the quality of care they deliver.
Although the World Health Organization is not a regulatory agency, it frequently makes recommendations about the optimal diagnostics for specific diseases that have a major impact on the uptake and subsequent implementation of these tools at national levels. In this talk, Dr. Murray will outline some of the steps involved in WHO’s process of developing target product profiles and developing guidelines around the use of diagnostic tests. Using tests for the diagnosis of tuberculosis as an example, she will elaborate on some of the hurdles that must be overcome to get approval for a diagnostic tool and to ensure that these tests fulfill their intended function.