US FDA approves Waters' at‑home cervical cancer screening kit
- By Reuters -
- Apr 08, 2026
Lab equipment maker Waters said on Wednesday the US. 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 approximately 60 percent of cervical cancer cases occur in individuals who are unscreened or under-screened.
Expanding screening options and access, including at-home self-collection, has been identified by public health experts as an instrumental strategy for improving early detection and reducing cervical cancer deaths.
The self-collection kit, tested with BD’s 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 US 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.