COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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FDA Releases New EUA Template for COVID-19 Screening Tests that Involve Serial Testing

FDA maze of regulations

New FDA template encourages and facilitates the development of serial testing for COVID-19 screening

The US Food and Drug Administration (FDA) announced the release of a new supplemental template for test developers seeking emergency use authorization (EUA) of certain COVID-19 tests for screening using serial testing. According to the FDA, “Serial testing involves testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test.”

This new template was released in coordination with updated US Centers for Disease Control and Prevention (CDC) guidance and is designed to help encourage and facilitate the development of COVID-19 screening tests.

“Today, we are providing information for test developers about a streamlined path to emergency use authorization for these important screening tools as well as information to help these groups as they set up testing programs,” said Jeffrey Shuren, MD, Director of the FDAs Center for Devices and Radiological Health, in a statement. “We believe this effort will pave the way for further expanding the availability of tests authorized for screening asymptomatic individuals, help bolster existing and new testing programs and increase consumer access to testing.”

The FDA notes that this template “applies to developers of molecular and antigen tests, for use in serial testing programs, as well as at-home tests for use in a serial manner outside of a testing program, intended to detect SARS-CoV-2 from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection.”

This template includes tests conducted at any location, including clinical laboratory testing, at-home testing, and testing in public locations. Clinical laboratorians or test developers wishing to access the new template can do so here.

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