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Bioneer Obtains CE-IVD Marking for HIV-1 Kit

NEW YORK (GenomeWeb) — South Korean molecular diagnostics firm Bioneer said today that it has received CE-IVD marking for its RT-PCR-based HIV-1 quantitative analysis kit.

The kit is designed to quantify HIV-1 RNA in blood samples and runs on Bioneer's ExiStation automated molecular diagnostics system. It is now available in the EU and countries recognizing the CE mark.

Bioneer said it is the first Asian company to receive CE-IVD marking for an HIV-1 quantitative analysis kit.

In 2016, Bioneer said its three-in-one test kit for Zika, dengue, and chikungunya viruses were deemed eligible for procurement by the World Health Organization.