www.fdanews.com/articles/198415-neumodx-gets-ce-mark-for-quantitative-bk-virus-assay
NeuMoDx Gets CE Mark for Quantitative BK Virus Assay
August 7, 2020
NeuMoDx has earned a CE mark for its quantitative BK virus polymerase chain reaction (PCR) assay.
The test is designed for patients who have undergone organ transplantation and may be immunocompromised. BK virus, which was named after the first person found to be infected, can spread from one patient to another during an organ transplant.
The freeze-dried assay is stable at room temperature for two years and produces results in about one hour.