FDA Greenlights First All-in-One Home COVID-19 Test, with Results in 30 Minutes - COVID-19 Clinical Trial
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FDA Greenlights First All-in-One Home COVID-19 Test, with Results in 30 Minutes

The FDA has authorized its first all-in-one COVID-19 diagnostic that allows people to test themselves within their own home, from a swab to a result in about 30 minutes. Developed by Lucira Health, the kit shrinks a molecular test for the novel coronavirus’s genetic code down to a handheld unit, complete with all the chemical reagents needed to perform the analysis.

The prescription-only test can be used at home by people ages 14 and older, though it is available to all ages when given in a doctor’s office, clinic or emergency room, with the swabbing being performed by a trained healthcare provider. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” FDA Commissioner Stephen Hahn said in a statement. After whisking the inside of both nostrils, the swab is placed into a fluid-filled vial. The sample then snaps into the top of the testing unit, which runs off two AA batteries.


AstraZeneca Taps CCT Research for COVID-19 Vaccine Tests

U.K. Big Pharma AstraZeneca and academic partner the University of Oxford are tapping research services firm CCT Research for their COVID-19 shot tests in Arizona. AstraZeneca is currently flying the flag for a more traditional vaccine approach to COVID-19 compared to rival late-stagers Moderna and Pfizer/BioNTech, with its shot, AZD1222, using adenovirus tech.

Its rivals are a little further along, having both this month revealed 90%-plus efficacy top-line data readings for their mRNA attempts, but AZ is storming up from behind. To aid in these efforts to get over the finishing line, the Big Pharma has asked CCT to help recruit 1,500 patients for a new test in Arizona. The firm works as a clinical site network, embedding research studies within local communities. The study, which will take place at Bayless Integrated Healthcare’s downtown Phoenix location at 3620 N 3rd St., is assessing healthy adults getting the vaccine against a placebo. A trial of the vaccine was stuck on a clinical hold for several weeks by the FDA after a safety scare but was given the green light a month ago to restart.

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