Research & Development
LuminUltra submits GeneCount COVID-19 clinical diagnostic testing kit for regulatory authorization in US, Canada
15 September 2020 -

Canadian biotechnology company LuminUltra reported on Monday that it has filed its GeneCount COVID-19 RT-qPCR Assay Kit with the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) and to Health Canada for an Interim Order (IO).

Following approval from both agencies, LuminUltra stated that its facilities throughout North America will be able to select the company's COVID-19 testing devices based on respective requirements 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.

The company added that its accurate GeneCount COVID-19 RT-qPCR Testing Solution is comprised of 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.

In response to Government of Canada's testing needs earlier in the year, the company also said it has been a key supplier of the isolation reagents for the national testing programme since April, providing 500,000 tests a week.