Gemina Labs Nears Completion of Phase 2 Human Patient Testing for Initial Diagnostic Test
VANCOUVER, BC / ACCESSWIRE / April 28, 2022 / Gemina Laboratories Ltd. (CSE:GLAB) (FRA:8I7) (the “Company” or “Gemina“) is pleased to announce that human subject testing for its COVID-19 rapid antigen test is in its final stages, with completion and full data readout expected in May 2022.
With extremely encouraging results in hand from its Phase 1 work with International Point of Care (“IPOC”), Gemina Labs moved into Phase 2 development work on its COVID-19 platform with human subjects. A clinical performance study with prospectively collected patient samples was initiated in early April 2022 at Centro Diagnostico Buonarroti in Civitavecchia, Italy. The Buonarroti Diagnostic Centre is a leading health facility with expertise in the provision of diagnostic testing and clinical analysis for Italy’s general population, with a specific expertise in COVID-19 testing. Three weeks into the study, more than 300 tests have been administered to determine sensitivity and specificity while being compared with both RT-PCR results (generally considered the ‘gold standard’ of testing), and to a widely used, commercially available rapid antigen test. Results collected thus far with the Gemina test have exceeded expectations. Upon completion of the study, the Company will release the performance data associated with the full complement of human tests.
In addition to the patient sampling evaluation underway in Italy, extensive testing continues with IPOC. IPOC has produced a second feasibility lot of 2500 Gemina COVID-19 tests which are currently undergoing expanded limit of detection, cross-reactivity, interfering substances, stability, and shelf-life studies.
The performance studies now being undertaken, along with the accompanying document generation, and ongoing branding and product design work, moves Gemina’s COVID-19 project into the final phases of the three-month work program as outlined in our February 3rd, 2022 technical update news release.
Legio X Gemina Branding
Gemina Labs has trademarked the brand Legio X Gemina for use with its line of point of care diagnostic tests. Looking forward, Gemina’s COVID test will now be referred to as the “Legio X Gemina COVID-19 Rapid Antigen Test”.
Launch of Second Diagnostic Test Development Program.
In anticipation of the successful completion of the Legio X Gemina COVID-19 Rapid Antigen Test development program, Gemina has initiated the development of its Influenza A/B rapid test prototype. This is an important demonstration of our proprietary chemistry platform’s ability to flexibly pivot to new diagnostic targets. The Company will provide further updates on this new program in the weeks to come.
“We are excited to be meeting these milestones in our development program,” commented Gemina CTO, Robert Greene. “We are advancing our chemistry at a determined pace currently, and much of that progress is attributable to the strong performance of our chemistry, which clearly is emerging as the disruptive platform we envisioned. The results from Italy thus far are extremely encouraging, and we look forward to sharing details as we complete these human trials.”
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
John Davies
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 regrading the Company, please contact:
James Tansey
Telephone: 604-562-4546
Email: investor@geminalabs.com
SOURCE: Gemina Laboratories Ltd.
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