GEMINA LABORATORIES LTD.
February 3, 2022
GEMINA LABS ANNOUNCES COMPLETION OF SIGNIFICANT DEVELOPMENT STEP FOR ITS SARS-COV-2 RAPID TEST
February 3, 2022, Vancouver, British Columbia: Gemina Laboratories Ltd. (CSE: GLAB) (FRA:8I7) (the “Company” or “Gemina”) is pleased to provide an update on its current activities related to the development of its first rapid diagnostic test targeting the SARS CoV-2 antigen, using the Company’s patented breakthrough chemistry platform. Following the previously announced prototype design freeze for use in saliva and the transfer of the prototype to International Point of Care (“IPOC”), the company is pleased to announce the completion of another important milestone, namely: design freeze for shallow nasal swab testing. From a regulatory perspective, nasal swabs have become the leading method for large scale rapid testing globally.
Gemina’s team previously announced that their SARS-CoV-2 test has already demonstrated outstanding performance in a lab setting. Independent laboratory results with Gemina’s prototype SARS-CoV-2 rapid antigen test indicated the company was able to reliably detect recombinant SARS-CoV-2 nucleocapsid in saliva and nasal fluid samples with significantly higher sensitivity when compared with a panel of seven leading commercial rapid antigen tests (Lancet – Corman, et al. 2021).
This latest milestone indicates that the performance of this finalized test design with inactivated virus and with real patient samples is sufficient evidence to initiate the production of three feasibility lots (of 3,500 rapid tests per lot) which will undergo third party performance evaluations. The test has been optimized for use with anterior (shallow) nasal swab samplesin response to market and regulatory signals. Detection of inactivated virus in artificial nasal fluid at clinically relevant concentrations has been independently confirmed by an external laboratory using the Gemina test. A second independent evaluation is scheduled to occur within the next week. The test has also been run against nasal fluid provided from a panel of COVID-negative volunteers and shown to exhibit no non-specific binding (no false positive signals).
In the following three months, the test will be taken through a series of sensitivity and specificity trials in advance of feasibility lot production, including evaluation of test specificity against seasonal coronaviruses. Three feasibility lots will then be tested to confirm sensitivity, usability, shelf stability, and lot-to-lot consistency with contrived inactivated virus samples. The test will then be subjected to an external performance evaluation with retrospective patient samples as part of the compilation of the data pack required to support regulatory submissions. Successful completion of these performance evaluations is a critical step towards manufacturing scale-up and allows the company to advance commercialization efforts through distribution and licensing agreements.
“Our partnership with IPOC to support the advancement of our first COVID diagnostic test is proving successful, and we continue to see encouraging, clinically relevant results from the first product development programme to emerge from our broad and robust technology platform,” commented Rob Greene, Founder and CTO of Gemina Labs. “The resurgence of the Omicron variant in recent months makes it clear that we may need high performance rapid tests for years to come, in order to detect and
control the spread of COVID-19. Today’s milestone provides another layer of evidence that we are developing the pandemic response platform and product that we set out to achieve.”
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.
International Point of Care is a leading Canadian company that develops, manufactures and supplies unique biological reagents, raw materials, and lateral flow components for the in-vitro diagnostic industry and the research and development community.
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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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