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Cue Health (HLTH) Granted FDA Emergency Use Authorization for Molecular Mpox Test

Cue Health (HLTH) Granted FDA Emergency Use Authorization for Molecular Mpox Test
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Cue Health Gets FDA EUA for Monkeypox Molecular Test

The nucleic acid amplification test returns results in 25 minutes and is authorized for use in professional point-of-care settings. ....

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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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Cue Health Launches 'Cue for Schools,' an On-Site Molecular Testing Solution for K-12 and Universities

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SAN DIEGO, April 5, 2021 /PRNewswire/ Cue Health Inc. ( Cue ), a healthcare technology company, today announced Cue for Schools, a COVID-19 on-site testing solution for K-12 schools and universities that uses the Cue Health Monitoring System and the Cue COVID-19 Test for Home and Over The Counter (OTC) Use, the nation s first molecular diagnostic test available without a prescription with Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Cue s easy-to-use, portable COVID-19 test provides lab-quality results directly to connected mobile smart devices in about 20 minutes and Cue s natively digital platform allows for end-to-end integrated reporting to meet both state and federal reporting standards. Cue s OTC COVID-19 test can be administered by anyone, anywhere making it easy for schools to utilize. As part of the Cue for Schools program, schools will receive customized on-site or virtual support ....

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FDA gives Cue Health first EUA for at-home, OTC COVID-19 molecular testing

The system delivers its results to a companion app in about 20 minutes, according to the agency. ....

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