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NEW YORK – Relatively few tests marketed for use at home have been cleared by the US Food and Drug Administration, but test developers in 2019 continued to innovate, collaborate, and raise funds in anticipation of future successes.

According to diagnostic test developers, more at-home tests, sometimes referred to as self-tests, need to demonstrate affordability and have levels of performance as high as, or better than, laboratory tests to achieve regulatory clearances and market acceptance.

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As worldwide COVID-19 cases continue to rise, there is a significant need to increase testing and population surveillance capacity.

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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.