Tags: fda | waters | at home cervical cancer screening kit

FDA Approves Waters' At-Home Cervical Cancer Screening Kit

Wednesday, 08 April 2026 10:53 AM EDT

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 people who are not screened or are screened less often than recommended.

* 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 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. 

© 2026 Thomson/Reuters. All rights reserved.


Politics
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.
fda, waters, at home cervical cancer screening kit
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2026-53-08
Wednesday, 08 April 2026 10:53 AM
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