French company Eurobio Scientific has obtained CE mark for its test EBX 047, Eurobioplex SARS-CoV-2 Fast-SVD – Screening and Variants Detection. The multiplex polymerase chain reaction kit is intended for routine Covid-19 testing and detection of present SARS-CoV-2 variants. It can check for the presence of the virus and differentiate between K417N, L452R and E484K mutations to detect Omicron, Beta Gamma and Delta variants. Requiring a single reaction and providing results in 45 minutes, the kit is offered in various versions to carry out 48, 96 or 192 tests.
Celltrion has boosted the distribution of its Covid-19 antigen test kits to the US on obtaining emergency use authorization (EUA) from the US Food and Drug Administration (FDA), Korea Biomedical Review reported. Jointly developed by Celltrion and Humasis, the DiaTrust COVID-19 Ag Home Test is intended for use in individuals of the age 14 years and above without needing a prescription from a physician. The company updated a contract with its US subsidiary to increase the shipments of Covid-19 test kits and the contract termination date has been altered. With the update, the company will now receive an upfront payment of $141.4m (KPW167.3bn).
HealthTrackRx has retained the US Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) to carry out the Molecular Laboratory Developed (LDT) COVID-19 Authorized Test. The laboratory is one among the 27 labs in the country authorised to use such tests under the EUA. The real-time polymerase chain reaction test for Covid-19 can precisely identify pathogens on the molecular level. The technology aids in delivering quick results within 24 hours.