BD's Automated Molecular Diagnostics Platform Wins FDA Approval, Initial Test For HPV

  • Becton Dickinson and Co BDX has received FDA approval for its automated, sample-to-answer, high-throughput BD Cor system along with the BD Onclarity HPV Assay for extended genotyping of human papillomavirus (HPV).
  • The modular and scalable BD Cor includes an automated sample preparation system, BD Cor PX, and an instrument that automates the BD Onclarity HPV assay, BD Cor GX. 
  • The PX instrument enables the preparation of specimens for testing. 
  • The BD Cor enables the processing of samples directly from liquid-based cytology vials, as well as the creation of molecular aliquot tubes and assay testing, automating labor-intensive and error-prone manual processes.
  • The Cor has onboard capacity for reagents and samples to provide six to eight hours of system processing.
  • The BD Cor was initially launched in Europe in 2019.
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: BDX shares are down 0.19% at $247.39 during the market session on the last check Wednesday.
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Posted In: NewsHealth CareFDAGeneralBriefsDiagnosticshuman papillomavirus
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