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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.

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