GenScript USA, a subsidiary of biotechnology company GenScript Biotech Corp., announced the immediate availability of a monkeypox virus PCR test kit.

The kit, which was developed in partnership with Anbio Biotechnology, can now be ordered by diagnostic labs and medical device distributors to be used in research to provide detection of the monkeypox virus.  The test kit has already received the CE mark for IVD use in the European Union (EU). Monkeypox cases are increasing rapidly around the world. As of Aug. 16, 2022, 12,869 cases of monkeypox have been reported in the U.S., per the US Centers for Disease Control. U.S. Department of Health and Human Services Secretary Xavier Becerra declared monkeypox a public health emergency on Aug. 4, 2022, a move that accelerates coordination across federal agencies, increases communication with states and localities, and helps the administration develop new strategies to distribute vaccines and treatments.

“Providing access to commercial test kits is essential so that we can quickly detect and understand how the virus is moving through our communities,” says Amanda Grimm, senior product manager of diagnostics at GenScript USA. “We are rushing supplies of the monkeypox PCR test kit to our lab customers and distributors because diagnostic labs across the United States are a crucial element of the nation’s response to this public-health emergency.”

Technical Information:

  • Qualitative assay for detection of monkeypox virus from various sample types, including the FDA recommended lesion swab samples
  • Amplifies two conserved gene regions of the monkeypox virus
  • Pseudovirus validation control available separately
  • For research use only (RUO) in the USA, CE Marking for EU use
  • Visit the GenScript monkeypox detection kit web page