Qualigen Therapeutics (NASDAQ:QLGN) is up 46% premarket after submitting an official notification to the FDA to commence sales of its FastPack SARS-CoV-2 IgG test for COVID-19 antibodies in the U.S.
This test has already been submitted for Emergency Use Authorization (EUA) but the notification enables the company to commence sales even before the FDA considers or formally grants the emergency use nod.
Qualigen expects sales and shipments of the new test to begin in mid-July.
It is designed for use with the company’s new FastPack PRO System point-of-care diagnostic instruments.
https://seekingalpha.com/news/3587687-qualigen-to-start-selling-covidminus-19-antibody-test-mid-july
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