FDA Authorizes First At-Home COVID-19 Test Available Without a Prescription - COVID-19 Clinical Trial
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FDA Authorizes First At-Home COVID-19 Test Available Without a Prescription

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    No search for an open COVID-19 testing center. No waiting in line. No need to even venture outside the house, in fact. That’s the promise of LabCorp’s Pixel test, which has secured an FDA green light for home delivery without a prescription. LabCorp’s home-testing push is one of the biggest in the industry, alongside sample collection kits from Everlywell and Quest Diagnostics, with the latter receiving a federal authorization earlier this week for a kit that tests for both COVID-19 and the flu. However, both require a note from a physician. The FDA first authorized the Pixel test in late April. Now, the self-collection kit can be purchased directly through LabCorp’s website by anyone age 18 and older—for $119 out-of-pocket, though the full price can be covered by public and private health insurance. 

    After swabbing the inside of the nose, the sealed sample is then shipped overnight in a prepaid FedEx envelope to a laboratory for analysis, with results turned around within one to two days on average. “With the first over-the-counter at-home collection kit ever authorized by the FDA for COVID-19, we are empowering people to learn about their health and make confident decisions,” said Brian Caveney, chief medical officer and president of LabCorp Diagnostics in a release. “With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities.”


    Cuomo: 26,500 First Doses of COVID-19 Vaccine Coming to Long Island

    Long Island will receive 26,500 initial doses of the COVID-19 vaccine from Pfizer as soon as this weekend as part of a first batch of 170,000 doses reserved for nursing home residents and staff and high-risk health care workers, Gov. Andrew M. Cuomo said Wednesday. New York City is slated to receive 72,000 initial doses. They are part of a wave of 6 million vaccines nationwide that the federal government is allocating to each state based on population, Cuomo said. The vaccine requires two shots, with the second delivered 21 days after the first. The governor said more deliveries of vaccines will follow on a regular basis to expand the pool of people vaccinated and administer second doses.

    The first vaccines “could arrive as soon as this weekend” in New York State, Cuomo said at a news briefing in Albany. “That assumes the FDA does act right away, the FDA does approve it, and the military turns around and ships it immediately.” The U.S. Food and Drug Administration could sign off on the Pfizer vaccine on Thursday, making it the first to gain approval in the United States. As soon as that happens, New York’s own panel will convene to review the vaccine and approve it. That is aimed at diluting skepticism about the federal approval process under the Trump administration, Cuomo added.

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