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FDA OKs first Zika diagnostic test in U.S.

  • The FDA approves Seattle, WA-based InBios International's ZIKV Direct 2.0 IgM Capture ELISA, the first ZIKA diagnostic test commercially available in the U.S.
  • The assay, which detects IgM antibodies to the Zika virus indicating recent exposure, was previously available under the agency's Emergency Use Authorization (EUA).
  • The FDA approved Roche's Zika screening test in October 2017. Chembio's point-of-care DPP Zika test for IgM antibodies has been available in the U.S. under EUA status since September 2017.
  • Related tickers: Chembio Diagnostics (NASDAQ:CEMI -0.6%), Co-Diagnostics (NASDAQ:CODX +0.6%), Roche (OTCQX:RHHBY +0.5%)

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