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CE Mark Applied to CorDx’s Latest Monkeypox Diagnostic Test

CorDx's three tests enable the detection of the monkeypox virus in humans; available for sale in the EU

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A CE Mark certificate was recently applied to the latest of three monkeypox diagnostic tests produced by CorDx, a global leader in the development, manufacturing, and distribution of diagnostics and medical devices.

The most recent CE Mark enables CorDx to market all three tests in the European Union (EU).

CorDx’s three monkeypox diagnostics are:

  • The Monkeypox Virus IgM/IgG Ab Test, 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 Monkeypox Virus Ag Test, a lateral flow chromatographic immunoassay for the qualitative detection of monkeypox virus antigen in human rash exudates and blood samples.
  • The Monkeypox Virus Fluorescence PCR Kit, 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 Conformitè Europëenne (CE) Mark is the EU’s mandatory conformity marking for regulating goods sold within the European Economic Area.

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).

“We take any threat to public health seriously. CorDx’s foremost mission is to develop, manufacture, and distribute reliable, affordable diagnostic products that protect health and save lives,” said Jeff Yufeng Li, CorDx’s founder & CEO. “We’re honored to provide our important monkeypox diagnostic tools to families and healthcare providers in the EU.”

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