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Bioneer Receives CE IVD Mark for PCR Zika Detection Kit

NEW YORK (GenomeWeb) – South Korean molecular diagnostics firm Bioneer announced today that it has received CE IVD marking for its AccuPower ZIKV  (DENV, CHIKV) Multiplex Real-Time RT-PCR Zika virus detection kit.

The multiplex mosquito-borne virus panel is a qualitative nucleic acid assay that uses Bioneer's ExiStation Molecular Diagnostic System to rapidly test for Zika, Dengue, and Chikungunya simultaneously, the company said. The assay incorporates Bioneer's Dual-HotStart RT-PCR technologies, which include hotstart in both the PCR and reverse transcription steps, enhancing sensitivity and specificity. It can confirm infection within four hours of testing.

In 2014, Bioneer released a molecular test kit for Ebola that it had developed in collaboration with the Nigerian National Biotechnology Development Agency.

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