Canada-based biotechnology front-runner LuminUltra announced today that it has submitted its GeneCount® COVID-19 RT-qPCR Assay Kit (COVID-19 Assay) to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) and to Health Canada for an Interim Order (IO).
| FREDERICTON, NB, Sept. 14, 2020 /PRNewswire/ - Canada-based biotechnology front-runner LuminUltra announced today that it has submitted its GeneCount® COVID-19 RT-qPCR Assay Kit (COVID-19 Assay) to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) and to Health Canada for an Interim Order (IO). With authorization to use this key testing component, LuminUltra, a leader in field-based molecular diagnostic testing for over 20 years, will provide a complete clinical COVID-19 testing solution that can be customized for testing facilities throughout North America. LuminUltra’s accurate GeneCount® COVID-19 RT-qPCR Testing Solution comprises multiple components that together make up an end-to-end solution, including: sample collection kits; isolation reagents; the COVID-19 Assay; and a range of quick-detection qPCR testing devices with software for simple interpretation of COVID-19 test results in under two hours. With the authorization of the COVID-19 Assay, LuminUltra will be able to offer flexibility to appropriate facilities around the world by providing some or all of the necessary COVID-19 testing components from a single, reputable company. This reduces the need to source components from multiple suppliers, allowing facilities to onboard additional testing capacity quickly. Underscoring its reliable supply chain, LuminUltra responded promptly to the Government of Canada’s testing needs earlier in the year, and has been a key supplier of the isolation reagents for the national testing program since April, providing 500,000 tests a week. Facilities can select COVID-19 testing devices based on their respective requirements and size, from portable, qPCR testing devices that can assess up to 16 samples in under two hours period, to large format, high-capacity and automated qPCR and extraction devices. “Human diagnostic testing for COVID-19 has scaled up very quickly and has become complicated for users. We hear frustration as facilities are forced to source inflexible components for testing from different companies and work through supply chain issues since these products are in high-demand – all while trying to provide safe testing solutions for patients,” said LuminUltra Chairman and CEO Pat Whalen. “We have been working relentlessly to provide flexible solutions that we are confident in – all from one company with a proven track record of meeting demand.” LuminUltra has a history of biological testing innovation. Alongside the clinical diagnostic test, LuminUltra is also the creator of the GeneCount Environmental Monitoring Solutions – an on-site environment monitoring system that detects the presence of SARS-CoV-2, the virus that causes COVID-19, on surfaces, in the air, or in wastewater. This monitoring system, launched in May 2020, allows corporations, building managers, hotels, cruise ship operators, service providers and others to verify disinfection protocols as well as pinpoint potential asymptomatic and presymptomatic carriers within two hours. The GeneCount qPCR devices – both the portable and high-capacity options – can also run the environmental test, providing a holistic approach to pandemic management. The work done on research and development for the environmental test has helped to ensure a reliable and market-ready clinical test. Assets, including images of the GeneCount qPCR product and application photos, can be found here. About LuminUltra
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