VANCOUVER, BC / ACCESSWIRE / September 20, 2021 / 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-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). 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
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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