US Stocks: US FDA approves Waters' at‑home cervical cancer screening kit, shares up 4%

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.