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$LMNX On July 22 Luminex submitted their "ABC Test" (Flu A, Flu B, Covid-19 assay) combo NxTAG RPP (19 viral+2 bacterial targets) for FDA EUA approval. Today, Sept 24th, we got $5.4M BARDA award to submit that ABC test for full 510(k) filing.MrMagician, published September 29, 2020
Explaining like you're 5:
"FDA EUA approval" means you can sell the test so long as there's a declared pandemic.
"510(k) clearance" means the FDA has completed a full review, and you can sell the test forever.
I expect we will hear news soon that the ABC test has received FDA EUA approval, it's what typically happens in this situation.
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