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.
The NeuMoDx systems provide first results in one hour, with continuous sample loading and a random-access workflow with up to eight hours of walkaway time. They also use the firm's proprietary NeuDry reagents that do not require refrigeration, have a room temperature shelf life of more than one year, and an onboard stability of 60 days. NeuMoDx also sells reagents and consumables for customers to create laboratory-developed tests on the systems.
"We are very pleased with our continued progress in expanding the menu on the first truly continuous random-access platform on the market," said Dan Harma, NeuMoDx chief commercial.