www.fdanews.com/articles/197529-quantumdx-nabs-ce-mark-for-covid-19-assay
QuantuMDx Nabs CE Mark for COVID-19 Assay
June 9, 2020
QuantuMDx’s COVID-19 real-time reverse transcriptase (rtRT) polymerase chain reaction (PCR) assay has earned CE mark certification.
The assay delivers results in 75 minutes or less, and its reagents come freeze-dried in a single vial.
Through a manufacturing agreement with Biofortuna, QuantuMDx is currently capable of producing 2 million tests per week.