www.fdanews.com/articles/203550-biolyticals-hepatitis-c-virus-antibody-test-gets-ce-mark
BioLytical’s Hepatitis C Virus Antibody Test Gets CE Mark
July 14, 2021
Canadian in vitro medical diagnostics company bioLytical Laboratories has received the CE mark for its hepatitis C virus (HCV) antibody test.
In clinical studies, the test demonstrated more than 99 percent accuracy, according to the British Columbia-based company.
The portable antibody test takes just one minute after a fingerstick, does not require any additional equipment and can be performed in “a multitude of settings with easy-to-interpret results,” the company said.