CorDx Receives CE Mark for Two Monkeypox Tests

Atlanta, Ga.-based CorDx has gained CE mark certifications for two monkeypox diagnostic tests.

The CorDx Monkeypox Virus Fluorescence polymerase chain reaction (PCR) test, detects nucleic acid from the monkeypox virus in rash exudates, whole blood and plasma samples, and it can be used as an auxiliary diagnostic tool in clinical settings.

The second test, the CorDx Monkeypox Virus IgM/IgG Ab Test is a lateral flow chromatographic immunoassay used for detection of monkeypox virus IgM and IgG antibodies in whole blood and plasma samples.

With the CE marks in hand, CorDx will launch in the EU where more than 16,000 confirmed cases of monkeypox infection had been reported since the start of the outbreak.