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8th Apr, 2026 12:00 AM
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US FDA Approves Waters' At‑home Cervical Cancer Screening Kit

April 8 (Reuters) - Lab equipment maker Waters 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.

Shares of the ‌company were up about 4% in early trading.

  • Waters said about 60% of cervical cancers occur in peoplewho are not screened or are screened less often thanrecommended.
  • The self-collection ‌kit, tested with BD's Onclarity HPVassay, is designed to ​detect ‌all high-risk types of humanpapillomavirus, ‌Waters added.
  • Patients can collect a sample at home and mail it ⁠to alaboratory, with results shared with ‌their healthcare provider,the ⁠company said.
  • The ​World Health Organization estimates that ‌persistentHPV infection of the cervix, if untreated, causes around 95% ofcervical cancers.
  • The company said it worked with the ​U.S. National CancerInstitute to confirm the ‌accuracy ‌of home sample collection.
  • Waters said it is setting up partnerships ‌to make ​the kitavailable nationwide by prescription in the coming months.
  • The company said the kit is expected to be ⁠covered byprivate insurance as well as federal ‌programs such as Medicareand Medicaid.

(Reporting by Sahil Pandey in ​Bengaluru; Editing by Vijay Kishore)


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