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

April 8 (Reuters) – 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 peoplewho are not screened or are screened less often thanrecommended. * The self-collection kit, tested with BD’s Onclarity HPVassay, is designed to detect all high-risk types of humanpapillomavirus, Waters added. * Patients can collect a sample at home and mail it to alaboratory, with results shared with their healthcare provider,the company said. * The World Health Organization estimates that persistentHPV infection of the cervix, if untreated, causes around 95% ofcervical cancers. * The company said it worked with the U.S. National CancerInstitute to confirm the accuracy of home sample collection. * Waters said it is setting up partnerships to make the kitavailable nationwide by prescription in the coming months. * The company said the kit is expected to be covered byprivate insurance as well as federal programs such as Medicareand Medicaid.

(Reporting by Sahil Pandey in Bengaluru; Editing by Vijay Kishore)