Biotechnology Leader LuminUltra Submits COVID-19 Clinical Diagnostic Testing Kit for Regulatory Authorization in U.S., Canada

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.