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Orasure Says FDA Requested Added Information on Test Application

Dec. 21, 2020, 9:06 PM

OraSure Technologies said the FDA has requested additional information as part of its review of the company’s application for Emergency Use Authorization for its laboratory-based oral fluid Covid-19 antibody test.

  • The OraSure SARS-CoV-2 Antibody ELISA is intended for qualitative detection of total antibodies to SARS-CoV-2 in human oral fluid specimens collected with the OraSure Oral Antibody Collection Device
  • The company intends to resubmit two separate EUAs for the ELISA and the oral specimen collection device
  • In addition, the FDA has requested that additional analytical studies be conducted on sample collection and stability

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