Diagnostic tests are an important tool in anticipating and meeting the continuing and evolving public health needs as we combat covid-19. FDA took a meaningful step forward in getting more tests to more Americans more quickly and making that process even easier for developers by posting template updates regarding the validation of molecular diagnostic tests for developers that intend their assay to be used for pooling patient samples or for screening asymptomatic individuals not suspected of having covid-19.
FDA has authorized molecular diagnostic tests for individuals suspected of having covid-19 by their healthcare provider. Such individuals can be symptomatic, presymptomatic, or asymptomatic. It has always been a healthcare provider’s discretion to test asymptomatic individuals when warranted. Using covid-19 diagnostic tests in this way is not the same as using such tests as a broad screening tool.

FDA has now outlined the steps for a test to be authorized for broad screening of asymptomatic individuals by publicly providing information in updated templates for test developers on FDA’s expectations for how a test can be validated for screening of asymptomatic individuals. This will make it easier for developers to get their tests authorized for this use. FDA recognizes that organizations may want to conduct screening of asymptomatic individuals as part of a broader strategy to help ensure the safety of their employees, patients, students, and others. In addition to these template updates, the FDA has made available FAQs with information regarding tests for screening asymptomatic individuals.

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