Macrogen has received a European community in-vitro diagnostic device (CE-IVD) certification for its fast-test kit for Covid-19, the Axen™ COVID-19 IgM/IgG RAPID. The kit can detect the presence of antibodies within 15 minutes using a small blood sample. It demonstrated 97% accuracy in the Seoul National University Hospital clinical trial. Macrogen secured the overseas business rights for the ImmuneMed kit in February and will export the kits as its own brand.
Aptamer Group, a biotechnology company, has entered into a partnership with Mologic, a lateral flow and rapid diagnostic tests developer, to work towards acquiring the CE mark for Aptamer’s AptaDx SARS-CoV-2 lateral flow rapid antigen test for professional use. The test detects the viral spike protein antigen in anterior nasal swabs. Initial test results have shown high sensitivity to detect the virus and other dominant emerging variants.
Pharmaceutical company XPhyto, and its exclusive Germany diagnostics development partner 3a-diagnostics, have received European approval for its point-of-care Covid-19 RT-PCR test systems called the Covid-ID Lab. The test has demonstrated high sensitivity, specificity, and robustness and can deliver results in 25 minutes. The Covid-ID Lab is now registered within European Union (EU) as a commercial in vitro diagnostic (CE-IVD) test and is expected to be launched for sale by April 2021.