NEW YORK – NeuMoDx confirmed today it has received CE-IVD marking on assays to detect and quantify levels of hepatitis B virus and hepatitis C virus. The two assays are now available in Europe.
The Ann Arbor, Michigan-based firm is focused on high-volume central laboratory customers, and the HBV and HCV tests could be particularly useful to labs serving immunocompromised populations or monitoring HBV DNA and HCV RNA titers for therapy management, the firm noted in a statement.