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

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.