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Alias Born 11/30/2023

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Saturday, 12/02/2023 1:11:59 PM

Saturday, December 02, 2023 1:11:59 PM

Post# of 36
Lets stop for a moment and recognized what has transpired, prior to COVID-19 you could only test for HIV at home, and approval was a 10-year process. The next phase of this, is now taking the momentum for COVID-19 home testing with EUA's, and appyling it to a broader range of issues, a broader range of pathogens; and with 510K's (substantially equivalent) and De Novo (not present substantial risk to user/patient) approvals now taking months instead of years (as with a PMA). Out of necessity came reform and now a sweet spot for Cue and with that has an overwhelming advantage!
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