LuminUltra submits COVID-19 diagnostic for approval

By staff writers

September 14, 2020 -- Molecular diagnostics company LuminUltra has submitted its GeneCount COVID-19 reverse transcription-quantitative polymerase chain reaction (RT-qPCR) assay for emergency use authorization with the U.S. Food and Drug Administration (FDA). The Canada-based company also submitted an interim order with Health Canada.

With approvals from the U.S. and Canadian agencies, LuminUltra will be able to provide its complete COVID-19 testing solution for facilities in North America.

The COVID-19 RT-qPCR assay is a part of the company's end-to-end testing solution for the novel coronavirus that can provide test results in under two hours, according to LuminUltra. The company's other COVID-19 offerings include sample collection kits, isolation reagents, and qPCR devices.

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Last Updated ls 9/21/2020 8:35:49 AM

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