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

Becton Dickinson and Co

08/04/2026 14:23

April 8 (Reuters) - 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.

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

 ((Sahil.Pandey@thomsonreuters.com;))