Beroni Group Announces Submission of Emergency Use Authorization to US FDA for its COVID-19 Rapid Test Detection Kit

Beroni Group Announces Submission of Emergency Use Authorization to US FDA for its COVID-19 Rapid Test Detection Kit

On March 26, 2020, Beroni Group Limited (OTCQX: BNIGF; NSX: BTG) , an international diversified biopharmaceutical enterprise focused on the research, development, innovation and commercialization of therapies and products for treatment of global diseases, today announces submission for an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its IgG/IgM antibody SARS-CoV-2 rapid test detection kit.

The SARS-CoV-2 IgG/IgM antibody detection kit based on colloidal gold is a rapid single use immunochromatographic test intended for the qualitative detection of IgG and IgM protein from the SARS-CoV-2 virus in capillary “fingerstick” whole blood, plasma, and serum samples.

Beroni’s request for EUA is currently under review by the FDA. If the FDA concludes that the criteria for issuance of an EUA has been met, the company will commence manufacturing and shipment of test kits to customers.

The full announcement can be found at the following website:

https://www.nsx.com.au/ftp/news/021737996.PDF

This news is also highlighted in various media sites, as follows:

BioSpace

https://www.biospace.com/article/releases/beroni-group-announces-submission-of-emergency-use-authorization-to-us-fda-for-its-covid-19-rapid-test-detection-kit-live-webcast-at-virtual-life-sciences-investor-forum-12-30pm-est-march-26-2020-/

Biocentury 

https://www.biocentury.com/article/304515

Reuters

https://www.reuters.com/article/brief-beroni-group-announces-submission/brief-beroni-group-announces-submission-of-emergency-use-authorization-to-fda-for-covid-19-rapid-test-detection-kit-idUSASA00J0P

Benzinga

https://www.benzinga.com/pressreleases/20/03/g15672682/beroni-group-announces-submission-of-emergency-use-authorization-to-us-fda-for-its-covid-19-rapid-

StreetInsider

https://www.streetinsider.com/Globe+Newswire/Beroni+Group+Announces+Submission+of+Emergency+Use+Authorization+to+US+FDA+for+its+COVID-19+Rapid+Test+Detection+Kit/16666407.html

EIN Presswire

https://www.einpresswire.com/article/513043602/beroni-group-announces-submission-of-emergency-use-authorization-to-us-fda-for-its-covid-19-rapid-test-detection-kit

MarketScreener

https://www.marketscreener.com/news/Beroni-Group-Announces-Submission-of-Emergency-Use-Authorization-to-US-FDA-for-its-COVID-19-Rapid-Te–30257503/

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