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

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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.



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