FDA Gives Emergency Use Nod To Roche's Monkeypox Test

  • FDA has granted Emergency Use Authorization for Roche Holdings AG's RHHBY cobas MPXV for use on the cobas 6800/8800 Systems. 
  • The test is a real-time PCR test for the qualitative detection of DNA from the monkeypox virus (MPXV) in lesion swabs collected from individuals suspected of monkeypox infection by their healthcare provider.
  • Cobas systems can also detect HIV, hepatitis B, and C viruses.
  • Cobas MPXV targets two regions of the MPXV genome, which are less prone to mutations than other parts of the genome. This dual-target approach ensures that cobas MPXV will continue to detect the virus even if a mutation occurs in one of the target regions.
  • "When multiple clusters of monkeypox virus infection were initially reported in countries where the disease is not endemic, Roche was among the first companies to address virus concerns with test kits," said Thomas Schinecker, CEO of Roche Diagnostics. 
  • The Food and Drug Administration said testing would be limited to laboratories that meet the requirements to perform moderate or high complexity tests.
  • Price Action: RHHBY shares closed at $41.36 on Tuesday.
  • Photo Jernej Furman from Flickr
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Posted In: BiotechLarge CapNewsHealth CareFDAGeneralBriefsMonkeypox
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