MiRXES Earns CE Mark for COVID-19/Flu Test

Singapore-based MiRXES’ Fortitude SARS-CoV-2/influenza test kit has received a CE mark in Europe and regulatory clearance in Singapore.

The multiplex test combines a reverse transcription polymerase chain reaction (RT-PCR) COVID-19 test kit with assays for influenza A and B, and can distinguish between SARS-CoV-2 viruses and flu pathogens.

The company said it is currently seeking Emergency Use Authorization from the FDA and approval from Japan’s Pharmaceuticals and Medical Devices Agency for the test.