CorDx Granted CE Mark for Two Monkeypox Diagnostic Tests

Diagnostics enable the detection of the monkeypox virus in humans

SAN DIEGO, Aug. 18, 2022 /PRNewswire/ — CorDx, a global leader in the development, manufacturing, and distribution of diagnostics and medical devices, 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).

"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 this important new diagnostic tool to families and healthcare providers in the EU."

About CorDx:

From its headquarters in Atlanta, Ga., CorDx is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world. Through its product realization partnerships with leading pharmaceutical companies, CorDx develops, manufactures, and distributes diagnostics and related tools that empower users to monitor and improve their health. Its proprietary line of diagnostics solutions is recognized by families and medical professionals for their reliability, affordability, and rapid results.

CorDx is a member of the CorDx Union, a biotechnology organization that delivers medical device solutions to healthcare industries and over a billion users in more than 170 countries.

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For more information contact:

Shuang Wills
Head of Staff, CorDx
(678) 680-2380