VANCOUVER, BC / ACCESSWIRE / December 13, 2022 / Gemina Laboratories Ltd. (CSE:GLAB)(FRA:8I7) (the "Company" or "Gemina") is pleased to announce that RAPIvD Limited ("RAPIvD") has met an important regulatory milestone.
On December 7, 2022, Gemina announced that it had entered into a definitive share exchange agreement to acquire 19% of the issued and outstanding shares of RAPIvD with the option, subject to certain conditions, to acquire all of the remaining issued and outstanding RAPIvD shares. Today, Gemina is able to announce that RAPIvD has achieved a significant certification, namely the International Organization for Standardization ISO 13485 medical devices standards for ‘contract development and manufacture of lateral flow assays for IVD' ("in vitro diagnostics"). The certification follows a rigorous operational audit by the British Standards Institution (BSI) and enables RAPIvD to manufacture lateral flow assays in-house.
Dr Robert Porter, RAPIvD's founder and CEO said. "Obtaining ISO 13485 certification means that we have passed another strategic milestone in our continued development. We set up our systems to meet the industry's best-practice standards and to have this ratified by the BSI and ISO is hugely beneficial. It recognises the hard work and application of our staff and assures our partners, customers and others in the supply chain, that we operate quality management processes and deliver high standards in everything we do".
Brian Firth, Gemina's CEO added "I'd like to pass on my congratulations to the RAPIvD team. This level of certification is no small achievement and adds significantly to our combined capacity to take lateral flow products into in-house manufacturing".
On Behalf of the Board of Directors
Gemina Laboratories Ltd.
About Gemina Laboratories Ltd.
Gemina Labs is a biosensor and diagnostic company with a transformative, patented, proprietary chemistry that powers next-generation testing platforms for a wide range of pathogens that affect human health and wellness. Our technology drives testing platforms that are fast, affordable and accurate, and easily self-administered. Our development pipeline includes platforms for the rapid testing of COVID-19, influenza and other viruses. Additional information on the Company can be found at www.geminalabs.com.
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Forward Looking Statements
This news release includes forward-looking information and statements, which may include, but are not limited to, information and statements regarding or inferring the future business, operations, financial performance, prospects, and other plans, intentions, expectations, estimates, and beliefs of the Company. Such statements include statements regarding the anticipated terms of any proposed transaction or engagement. Information and statements which are not purely historical fact are forward-looking statements. Forward-looking information and statements involve and are subject to assumptions and known and unknown risks, uncertainties, and other factors which may cause actual events, results, performance, or achievements of the Company to be materially different from future events, results, performance, and achievements expressed or implied by forward-looking information and statements herein. Although the Company believes that any forward-looking information and statements herein are reasonable, in light of the use of assumptions and the significant risks and uncertainties inherent in such information and statements, there can be no assurance that any such forward-looking information and statements will prove to be accurate, and accordingly readers are advised to rely on their own evaluation of such risks and uncertainties and should not place undue reliance upon such forward-looking information and statements. Furthermore, the Company is presently unable to fully quantify the impact that the Covid-19 pandemic will have on its operations and recognizes that certain eventualities may affect planned or assumed performance moving forward. As such, any forward-looking information and statements herein are made as of the date hereof, and except as required by applicable laws, the Company assumes no obligation and disclaims any intention to update or revise any forward-looking information and statements herein or to update the reasons that actual events or results could or do differ from those projected in any forward looking information and statements herein, whether as a result of new information, future events or results, or otherwise, except as required by applicable laws.
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SOURCE: Gemina Laboratories Ltd.