Qiagen's COVID-19 Antigen Test Gets FDA Emergency Use Approval

  • The FDA has granted emergency use authorization (EUA) to Qiagen N.V.'s QGEN QIAreach SARS CoV-2 Antigen Test.
  • The rapid, portable test can detect COVID-19 antigen in people with active infections in 2 to 15 minutes.
  • The test can process an average of around 30 swab samples per hour, providing digital test results that do not require subjective interpretation. 
  • The QIAreach test is the second Qiagen COVID-19 test to use the digital eHub and eStick system developed in partnership with Australian digital diagnostics company, Ellume.
  • Lab professionals will now be able to run tests to detect both previous and active infections on one device simultaneously, with each testing slot operating independently of the others.
  • Each Digital eHub device, with a capacity for up to 8 eSticks, can simultaneously run QIAreach COVID-19 antigen and antibody tests.
  • Related: Qiagen Stock Gains As Non-COVID Sales Boosts Q2 Topline, Bottom-line.
  • Price Action: QGEN shares closed down 0.72% at $52.36 on Friday.
  • Related content: Benzinga's Full FDA Calendar.
  • Photo by Mufid Majnun on Unsplash
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Posted In: NewsHealth CareFDAGeneralBriefsCovid-19
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