贝罗尼集团向美国FDA提交新型冠状病毒快速检测试剂盒紧急使用权申请

贝罗尼集团向美国FDA提交新型冠状病毒快速检测试剂盒紧急使用权申请

贝罗尼集团有限公司(“贝罗尼集团”)(OTCQX上市代码:BNIGF;NSX上市代码:BTG),是一家国际化、多元化的生物制药企业,主要致力于全球疾病治疗方式的研发及成果转化。2020年3月26日,贝罗尼集团宣布,其新型冠状病毒(SARS-CoV-2)IgG/IgM抗体检测试剂盒已向美国食品药品监督管理局(FDA)提交紧急使用权申请。

新型冠状病毒(SARS-CoV-2) IgG/IgM抗体检测试剂盒是一款基于胶体金技术的快速、一次性免疫层析检测试剂,旨在定性检测受检者全血、血浆和血清中的新型冠状病毒(SARS-CoV-2)IgG和IgM抗体。

目前,FDA正在审查贝罗尼集团的紧急使用权申请。若申请通过,贝罗尼集团将开始生产试剂盒并输送给客户。

点击以下链接可查看相关公告:

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

同时,全球多家媒体先后对此进行了报道,请点击以下链接查看:

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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