CorDx was recently granted a CE Mark certificate for two of the company's monkeypox diagnostic tests.
The CE Mark, granted on May 23, 2022, enables CorDx to market the tests in the European Union (EU).
The first test, the Monkeypox Virus Fluorescence PCR Kit, is used for the qualitative detection of monkeypox virus nucleic acid in human rash exudates/whole blood/plasma samples. It is also used for clinical auxiliary diagnosis and treatment.
The second test, the Monkeypox Virus IgM/IgG Ab Test, is a lateral flow chromatographic immunoassay used for the qualitative detection of monkeypox virus IgM and IgG antibodies in human whole blood/serum/plasma samples.
The Conformitè Europëenne (CE) Mark is the EU's mandatory conformity marking for regulating goods sold within the European Economic Area. It indicates that CorDx's monkeypox tests have been assessed and deemed to meet EU safety, health, and environmental protection requirements.
On July 23, 2022, the Director-General of WHO Dr. Tedros Adhanom Ghebreyesus declared that the multi-country outbreak of monkeypox is a public health emergency of international concern (PHEIC).