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Bioneer Gets Korean Approval for Zika Detection Kit

NEW YORK (GenomeWeb) – South Korean molecular diagnostics firm Bioneer announced this week that it has received approval from the Korea Ministry of Food and Drug Safety for its AccuPower ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Zika virus detection kit.

According to the company, 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 assay also incorporates the firm’s Dual-HotStart RT-PCR technologies, which include hotstart in both the PCR and reverse transcription steps, and can confirm infection within four hours of testing.

The Korean approval comes about five months after the test received CE-IVD marking.

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