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CorDx Gets CE-IVD Marks for Monkeypox Assays

NEW YORK — San Diego-based diagnostics firm CorDx said on Thursday that it has obtained CE-IVD marks for a PCR test and a lateral flow test for monkeypox.

The first, CorDx's Monkeypox Virus Fluorescence PCR Kit, tests for the virus in human rash exudates and blood and plasma samples. It can also be used for clinical auxiliary diagnosis, the company said. The second, the Monkeypox Virus IgM/IgG Ab Test, is a lateral flow chromatographic immunoassay that can be used to detect antibodies to the virus in blood.

CorDx obtained the certificates before Europe's new In Vitro Diagnostic Regulation came into force on May 26. The company can sell the assays through May 2026 before requiring clearance under the IVDR.

CorDx CEO Jeff Yufeng Li said in a statement that gaining CE-IVD marks was in line with the company's mission to make "reliable, affordable diagnostic products that protect health and save lives."

In March, the company announced the CE-IVD marking of a lateral flow chromatographic immunoassay for influenza A, influenza B, SARS-CoV-2, and respiratory syncytial virus.

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