Roche Holding AG wants their Ebola virus test approved for emergency use in the United States, according to Reuters.
Roland Diggelman, the company’s head of diagnostics, said Roche is in discussions for an emergency use application by the FDA, and that they also filed for CE mark approval by the European Union.
According to the report, it takes about two hours for their test to detect Ebola, and using their Roche LightCycler 480 machine, it is possible to run about 480 samples per day.
Laboratories that want to handle the samples will be required to fulfill specific safety requirements. It was not immediately clear what those safety requirements would be.
