LuminUltra Technologies Ltd. is proud to announce that we’ve submitted our GeneCount® COVID-19 RT-qPCR Assay Kit to the U.S. Food and Drug Administration for Emergency Use Authorization and Health Canada for an Interim Order.
With this authorization we’ll be able to provide testing facilities throughout North America with a complete, customizable clinical COVID-19 testing solution.
Everything you need from one trusted company
With the authorization of the GeneCount® COVID-19 RT-qPCR Assay Kit, LuminUltra will be able to offer flexibility to testing facilities around the world by providing some or all of the necessary COVID-19 testing components from a single, reputable company.
Facilities can onboard additional testing capacity more quickly, without the need to source components from multiple suppliers. We’re a proven supply chain, as a key supplier of the isolation reagents to the Government of Canada since April, providing 500,000 tests/week to their national testing program.
“Human diagnostic testing for COVID-19 has scaled up very quickly and has become complicated for facilities. We hear frustration as users 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,” says LuminUltra Chairman and CEO Pat Whalen.
“We have been working relentlessly to provide flexible solutions – all from one company with a proven track record of meeting demand.”
Facilities can select GeneCount® COVID-19 testing devices based on their needs and size, from portable, qPCR testing devices that can assess up to 16 samples in under two hours, to large format, high-capacity and automated qPCR and extraction devices.
Biological testing expertise
LuminUltra has a history of biological testing innovation. Alongside the clinical diagnostic test, we’ve created GeneCount® Environmental Monitoring Solutions – an onsite environmental surveillance system that detects the presence of SARS-CoV-2, the virus that causes COVID-19, on surfaces, in the air, or in wastewater within two hours.
The environmental test 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. The GeneCount® qPCR devices – both the portable and high-capacity options – also process the environmental test, providing a holistic approach to pandemic management.
Our accurate GeneCount® COVID-19 RT-qPCR Testing Solution includes multiple components to make up an end-to-end solution, including:
• sample collection kits;
• isolation kits
• the COVID-19 Assay; and
• a range of quick-detection qPCR testing devices with software for simple interpretation of COVID-19 test results with confidence in under two hours.
LuminUltra has a range of reliable, fast, and sensitive testing solutions to identify the presence of COVID-19 and SARS-CoV-2.
Contact us to learn more about a testing protocol to meet your needs.