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Ann: Atomo & Access Bio enter North American COVID-19 partnership, page-129

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  1. 1,209 Posts.
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    USA Today article (29 July) - just found this - strangely didn't show up before in my usual searches?:
    https://www.usatoday.com/story/news/2020/07/29/fda-opens-door-rapid-home-covid-19-tests/5536528002/

    - refers to US FDA publising out guidelines for at-home self-tests

    - also highlights a non-profit sponsored competition with $2m prize for the best "..test that delivers results in as little as 15 minutes and costs less than $15" (+ the sponsors can give additional $50m funding for manufacturing scale up anytime)

    - highlights examples of self-test usage potential across US population, "..before going to work or school, getting on an airplane, attending an event or visiting an elderly relative. Letting people know they are infectious in real-time would enable them to self-quarantine"..which we already see is a whole USA country problem; not knowing who is infectious where, gov testing taking too long, not enough tests anyway, no consistent plan in/between states etc etc

    - the relevant bit for us is at the end of the article - copied below:
    =========
    Test company official: FDA has 'moved the goalposts
    'In a third approach, Intrivo Diagnostics of Santa Monica, California, and Access Bio of Somerset, New Jersey, are collaborating to design and distribute a rapid at-home test. Dr. Michael Harbour, chief medical officer of Intrivo, said he expects to complete the FDA approval process in the next 90 days.Their test provides a finger-pricking device and analyzes a drop of blood. A blue line would indicate a positive for the virus; no line would be an all-clear. The test should be accurate enough to meet the FDA guidelines, Harbour said. The companies are prepared to conduct trials, as required by the FDA, to make sure the test is easy enough for most people to use. He said he did not know how much it would cost.The FDA, Harbour said, has "moved the goalposts" several times, requiring testing companies to follow one protocol and then another. But he's hopeful it's now clear how important this type of test will be to keep the virus under control.

    "If the FDA is smart," he said, "they are going to work quickly to make these available."
    =========

 
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