Novacyt Gets CE Marks for Winterplex, Escapeplex COVID-19 PCR Tests
Novacyt has received a CE mark for its Winterplex polymerase chain-reaction (PCR) test for diagnosis of COVID-19, respiratory syncytial virus (RSV) and some types of influenza.
The new version of its Winterplex test combines flu B, three-gene COVID-19, flu A and RSV assays in a single kit, and is designed for use in central laboratories with open PCR platforms.
The company has also earned a separate CE mark for its Escapeplex PCR test for identifying four COVID-19 variants.
Novacyt has been marketing Escapeplex as a research-use-only test since April. The new CE marked version is intended for clinical use.