VANCOUVER, BC / ACCESSWIRE / September 13, 2021 / Gemina Laboratories Ltd. (CSE:GLAB)(FRA:8I7) (the "Company" or "Gemina") is pleased to provide an update on its research and development ("R&D") activities and highlight both recent and forthcoming milestones within the R&D group as well as our corporate development initiatives.
Research and Development - Applying Gemina's Breakthrough Chemistry
The chemistry powering an effective diagnostic test has two elements - it captures the diagnostic target (i.e. the virus, bacterial pathogen, hormone) and, it connects with the sensor surface allowing it to produce a positive or negative result that is visible to the user.
The legacy chemistry of rapid testing has remained largely unchanged for years, limiting the performance and broad applicability of various tests, such as Lateral Flow Assays ("LFA"), which are commonly used in pregnancy tests and more recently, in COVID-19 rapid diagnostic tests. This is where Gemina's core chemistry has the potential to disrupt the diagnostic biosensor industry, and dramatically advance the performance of rapid testing.
Gemina's core biosensor platform is built around proprietary biochemistry that is designed for rapid and simple high-binding affinity attachment of capture molecules to biosensor surfaces, such as gold and nitrocellulose, which are commonly used in the sensor surfaces of LFA tests. This dual affinity for target capture molecules and for diagnostic sensor materials significantly simplifies the surface functionalization process and increases target capture capacity, resulting in increased sensitivities and detection of small amounts of the target of choice. Gemina's biochemistry can be produced affordably through highly scalable production processes, resulting in reduced costs throughout the diagnostic development process.
In the last 15 months, Gemina has moved rapidly through the process of constructing the novel surface chemistry platform for use in Lateral Flow Assays. Gemina's second-generation solution has demonstrated outstanding performance in a lab setting for its initial diagnostic target - SARS-CoV-2. Independent laboratory results with Gemina's prototype SARS-CoV-2 rapid antigen test indicate 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). In the context of COVID-19, higher sensitivity should allow for earlier and more reliable detection of the virus in patient samples. Since airborne transmission has played a critical role in the distribution of the COVID-19 virus, early, cheap and reliable detection plays a critical role as a public health measure to break chains of infection and prevent viral spread.
Gemina's current pathway to prototype design freeze was achieved at the end of June 2021 and our prototype was submitted to International Point of Care ("IPOC") for phase 1 manufacturability testing. IPOC 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. IPOC's specialty is in the area of rapid point-of care-testing and its customers include global biotech companies and small dedicated research labs and institutes around the world. Data from IPOC testing will indicate if the Gemina results produced in the laboratory can be replicated in a manufacturing setting. The report from phase 1 is expected to be received by Gemina in Q3, 2021.
Successful phase 1 results will move the Company into the final development and production phases in Q4 of 2021. The production of diagnostic tests will be used for submissions to the leading national regulatory bodies in North America and in the UK. Under the current diagnostic review pathways available to Gemina, the Company is aiming to be in a position to commercialize the initial test in the first half of 2022.
"The company has made tremendous progress towards the commercialization of our first diagnostic test," commented Robert Greene, CTO of Gemina. "The manufacturability results are a critical step towards this goal. Should the results show that our chemistry performs at or near the same levels we have experienced to date, we will know our proprietary platform is robust enough to manufacture at scale, bringing us one step closer to establishing Gemina as a new standard for powering a wide variety of point of care diagnostics for the medical and wellness markets."
"We are very pleased to have reached the manufacturabilty stage of our product development roadmap," added John Davies, CFO of Gemina. "Successful results will provide us the necessary evidence to begin our initial licensing outreach to the international pharmaceutical and diagnostics community."
Corporate Development Updates
The Company is pleased to announce it has been granted approval to begin trading on the Frankfurt Stock Exchange under the symbol "8i7". The WKN code for this security in Germany is "A3CWW7". Additionally, the Company has undertaken to list its shares on the OTCQB in the United States and procure DTC eligibility, thereby creating a viable market for the trading of Gemina shares for residents of the United States. Listing is expected to be completed within Q4, 2021.
The Company has granted stock options to certain directors, officers, and employees of the Company to purchase an aggregate of 900,000 common shares in the capital of the Company. The stock options are exercisable for a term of 5 years from the date of grant at an exercise price of 45 cents per common share, and subject to vesting provisions.
The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 virus. The Company will be seeking regulatory approval for our product(s) before sales and clinical use are permitted.
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 biochemistry 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.
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this Release.
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.