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Gemina Labs Receives Positive Initial Manufacturing Results for SARS-CoV-2 Diagnostic Test

Autor: Accesswire
20.09.2021, 20:25  |  107   |   |   

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 …

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.

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Gemina Labs Receives Positive Initial Manufacturing Results for SARS-CoV-2 Diagnostic Test 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 …

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