Beroni Group Announces Submission of Emergency Use Authorization to US FDA for its COVID-19 Rapid Test Detection Kit
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- Live Webcast at Virtual Life Sciences Investor Forum, 12:30PM EST, March 26, 2020 -
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NEW YORK and SYDNEY, Australia, March 26, 2020 (GLOBE NEWSWIRE) -- Beroni Group (OTCQX: BNIGF; NSX: BTG) (“Beroni” or the “Company”), 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.
Jacky Zhang, Chairman and CEO of Beroni Group, said, “Our immediate priority is to help our healthcare infrastructure address this global health emergency. Our scientific team has quickly developed a SARS-CoV-2 IgG/IgM antibody detection kit to accurately detect this highly contagious virus with both symptomatic and asymptomatic candidates. This detection kit is fast, simple to use and yields results in 10 minutes with only fingertip blood or venous blood required. Getting tests to detect COVID-19 into the hospitals, clinics, urgent care and pharmacies as soon as possible is one of our highest priorities in fighting this expanding pandemic. With a 97% accuracy rate, we are confident that our test kit will help increase the extent and quality of testing in severely affected countries.”
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.
Beroni will be presenting at the Virtual Life Sciences Investor Forum as follows:
DATE: Thursday, March 26th TIME: 12:30PM EST LINK: https://tinyurl.com/032620LSIF
This will be a live, interactive online event where investors are invited to ask the company questions in real-time. If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event.
It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates.
Learn more about the event at www.lifesciencesinvestorforum.com.
About Beroni Group LimitedBeroni Group is an international biopharmaceutical enterprise dedicated to the innovation and commercialization of drugs and therapies to combat various global diseases such as cancer and infectious diseases. Its diversified portfolio is comprised of a US FDA approved virus diagnostic kit, an e-commerce platform for the sale of pharmaceutical products and a development pipeline targeting oncology and cell therapies. Beroni has operations in Australia, United States, China and Japan. To learn more about Beroni, please visit www.beronigroup.com.
About Life Sciences Investor ForumLife Sciences Investor Forum is the leading proprietary investor conference series that provides an interactive forum for Life Sciences companies to meet and present directly with investors. A real-time solution for investor engagement, Life Sciences Investor Forum is part of Intrado’s suite of investor relations services specifically designed for more efficient Investor Access. Replicating the look and feel of on-site investor conferences, Life Sciences Investor Forum combine leading-edge conferencing and investor communications capabilities with a comprehensive global investor audience network.
About IntradoIntrado, formerly West, is an innovative, cloud-based, global technology partner to clients around the world. Our solutions connect people and organizations at the right time and in the right ways, making those mission-critical connections more relevant, engaging, and actionable—turning Information to Insight.
Forward-Looking Statements DisclaimerThis press release contains forward-looking statements or forward-looking information, within the meaning of applicable United States and Australian securities laws with respect to the Company. By their nature, forward-looking statements are subject to a variety of factors that could cause actual results to differ materially from the results suggested by the forward-looking statements. Accordingly, readers should not place undue reliance on the forward-looking statements. Generally forward-looking statements can be identified by the use of terminology such as “anticipate”, “will”, “expect”, “may”, “continue”, “could”, “estimate”, “forecast”, “plan”, “intend”, “believe”, “potential” and similar expressions.
Forward-looking information contained in this press release is based on Company management’s opinions, estimates and assumptions in light of its experience and perception of historical trends, current conditions and expected future developments, as well as other factors that management currently believes are appropriate and reasonable in the circumstances. Forward-looking statements involve significant risks, uncertainties and assumptions, and there can be no assurance that such statements, or its underlying risks, uncertainties and assumptions will prove to be accurate. Factors that could cause actual results or events to differ materially include, without limitation, risks related to laws, rules and regulation applicable to the Company as well as the industry in which it operates (including in respect of taxes and other levies), economic or market conditions on both a national and global level, currency fluctuations, risks inherent to other entities at a similar stage of development and industry in which the Company currently is, competition from the Company’s competitors, unsatisfactory development or marketing of the Company and/or its products or services, regulatory action or litigation (including product liability claims), and failure to enter into agreements or arrangements with other parties on fair or reasonable terms. Forward-looking information is made only as of the date on which it is provided and, except as may be required by applicable laws, the Company disclaims any intent or obligation to update such forward-looking information whether as a result of new information, future events or otherwise.
For more information, please contact:
Investor Contact:Vivian ChenImpact IRPhone: 917-449-4918Email: [email protected]
Media Contact:Cathy LoosImpact IRPhone: 347-334-4135Email: [email protected]
Life Sciences Investor ForumJohn M. ViglottiSVP Corporate Services, Investor AccessPhone: (212) 220-2221Email: [email protected]
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