US FDA approves Waters' at‑home cervical cancer screening kit

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Becton, Dickinson and Company

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Waters Corporation

WAT

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- Lab equipment maker Waters WAT.N said on Wednesday the U.S. Food and Drug Administration has cleared its at-home cervical cancer screening kit for use with an approved HPV test, potentially improving early detection and reducing deaths from the cancer.


  • Waters said about 60% of cervical cancers occur in people who are not screened or are screened less often than recommended.

  • The self-collection kit, tested with BD's BDX.N Onclarity HPV assay, is designed to detect all high-risk types of human papillomavirus, Waters added.

  • Patients can collect a sample at home and mail it to a laboratory, with results shared with their healthcare provider, the company said.

  • The World Health Organization estimates that persistent HPV infection of the cervix, if untreated, causes around 95% of cervical cancers.

  • The company said it worked with the U.S. National Cancer Institute to confirm the accuracy of home sample collection.

  • Waters said it is setting up partnerships to make the kit available nationwide by prescription in the coming months.

  • The company said the kit is expected to be covered by private insurance as well as federal programs such as Medicare and Medicaid.