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FDA Grants Marketing Authorization for Cue Health COVID-19 At-Home, Molecular Test

The nucleic acid amplification test is the first at-home, over-the-counter test for COVID-19 to be granted marketing authorization using the traditional premarket review pathway.

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FDA Permits Marketing of First COVID-19 At-Home Test Using Traditional Premarket Review Process

The U.S. Food and Drug Administration granted marketing authorization for the Cue COVID-19 Molecular Test.

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FDA Permits Marketing of Cue Health s (HLTH) COVID-19 At-Home Test Using Traditional Premarket Review Process

FDA Permits Marketing of Cue Health s (HLTH) COVID-19 At-Home Test Using Traditional Premarket Review Process
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Cureus | Laboratory and Point-of-Care Testing for COVID-19: A Review of Recent Developments

With the emergence of Coronavirus infection called COVID-19, testing is essential for containment and mitigation purposes. In a pandemic, control is essential to limit the spread of any virus. Initially, contact tracing was not available which ultimately led to the 2020 pandemic. However, with the development of COVID-19 rapid testing, the rate of infections has lessened and has allowed for some return to normalcy. In this review, we discuss the various antibody, antigens, and molecular tests that have been given emergency authorization (EA) from the Food and Drug Administration (FDA). Moreover, we will discuss the various point-of-care tests as well as the specificity and sensitivity that are associated with each testing kit. With appropriate testing, we can be aware of how the virus spreads and how prevalent it remains.

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Albertsons pharmacies add fast COVID-19 testing service

Cue Health rapid molecular test now offered at 900 of grocer’s Rx locations

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