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Sunday, 03/22/2020 4:58:37 PM

Sunday, March 22, 2020 4:58:37 PM

Post# of 11
$LMNX FDA Corona Approved Test Next?

$DHR just got FDA fast track approval over the weekend for their Cepheid Gene Xpert Flu test.

https://www.mercurynews.com/2020/03/21/coronavirus-test-45-minute-cepheid-sunnyvale-covid-19-test/

$LMNX has a VERY similar product called the Luminex Aires system that was approved by the FDA in 2016.

https://www.genomeweb.com/regulatory-news/luminex-receives-fda-clearance-influenza-ab-respiratory-syncytial-virus-assays#.XnebZNJKhPY

In fact the $DHR Cepheid Gene Xpert & Luminex Aires are considered the leading test systems for flu genes.

https://www.luminexcorp.com/download/comparison-cepheid-gene-xpert-flursv-xc-gx-luminex-aries-flu-ab-rsv-la-simplexa-flu-ab-rsv-direct-s-assays/

I would keep this one on watch, because $LMNX already stated last week that they are trying to get FDA EUA testing approval for the corona virus as well. Even though $DHR was the first, it is going to take way more than one test provider to meet world wide demand for these tests.

-Four independent clinical laboratories report data from evaluation of automated, sample-to-answer ARIES® System for rapid detection of SARS-CoV-2 virus

-Luminex has launched and begun shipping its Research Use Only (RUO) NxTAG® CoV Extended Panel

-Luminex is planning to submit an EUA (Emergency Use Authorization) for its NxTAG® CoV Extended Panel (RUO) by the end of this month

-Luminex intends to submit an EUA for an ARIES® SARS-CoV-2 Assay next month

https://finance.yahoo.com/news/luminex-provides-sars-cov-2-113000459.html

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