20 Sept 2021
Positive initial manufacturing results for Covid diagnostic test
GEMINA LABORATORIES LTD.
News Release September 20, 2021
GEMINA LABS RECEIVES POSITIVE INITIAL MANUFACTURING RESULTS FOR SARS-COV-2 DIAGNOSTIC TEST
September 20, 2021, 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. The results represent a significant milestone on the path to manufacturing Gemina’s first diagnostic test and demonstrates the power of Gemina’s chemistry in its ability to effectively test at lower limits of detection when manufactured at scale. This confirmation allows the company to begin exploring initial out-licensing opportunities.
Understanding the Phase 1 Results
Gemina products are built around our proprietary transformative chemistry platform that the Company believes significantly improves the performance, limit of detection and production of biosensors for a range of established and emergent diagnostic platforms, including rapid COVID-19 testing.
With respect to Gemina’s initial product development program – a COVID-19 rapid diagnostic test, Gemina achieved prototype design freeze at the end of June 2021 and transferred the program 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.
Phase 1 results indicate that IPOC was able to repeatedly detect 1 ng/mL of SARS-CoV-2 N protein in pooled human saliva. This result confirms earlier independent laboratory results with Gemina’s prototype SARS-CoV-2 rapid antigen test indicating the company was able to reliably detect recombinant SARS-CoV2 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). The low Level of Detection achieved in this test is five times better that the market leading tests evaluated in the Lancet study.
In the context of testing for viruses (like COVID-19), lower limit of detection will allow for earlier and more reliable detection of the virus in patient samples. Since airborne transmission plays a critical role in the distribution of the COVID-19 virus, having access to early, reliable and cost-effective detection plays a critical role as a public health measure to control or limit the chains of infection, and prevent or reduce viral spread.
The positive data resulting from the Phase 1 assessment allows Gemina to move into Phases 2 and 3 of the manufacturing trials at IPOC, which will subject the test to bench studies, including usability studies, cross-reactivity studies, and clinical trials with North American and European Health Agencies. Importantly for Gemina, the Phase 1 results and subsequent data from Phases 2 and 3 will also be used to initiate licensing negotiations with established international diagnostic test providers.
Following the saliva results, performance assessment in nasal fluid samples with both recombinant nucleocapsid antigen and with inactivated virus are now underway at IPOC with results expected in late Q3, 2021.
“This is a major milestone in our journey towards manufacturing our first biosensor built on our disruptive chemistry platform.” commented Rob Greene, founder and CTO of Gemina Labs. “Achievement of the 1 ng/mL limit of detection in a manufacturing setting is a strong result that allows us to move into Phase 2 with great confidence in the high performance of the test design.”
CEO John Davies added “It is becoming increasingly clear that despite the positive impact of large-scale vaccination programs, COVID cases continue to be a serious societal challenge. With new waves of the pandemic there is a clear demand for widespread, low cost, rapid population testing and screening as an essential public health measure. For regions of the developing world with low vaccination rates and lacking the infrastructure for molecular testing, low-cost rapid testing may be the principal public health measure. We believe Gemina Labs can make a major contribution to addressing this challenge at an international level.”
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
CEO 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.
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.
For more information regarding the Company, please contact: