Waters Gets FDA Approval for At-Home HPV Self-Collection Kit

By Robb M. Stewart

The Food and Drug Administration has given the go ahead to Waters' at-home cervical cancer screening tool, potentially removing a barrier that prevents many women from receiving routine screening.

The life sciences and diagnostics company said Wednesday the regulator cleared its Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use. Both are manufactured by Becton, Dickinson and Co.

Cervical cancer is largely preventable with regular screening and early detection of human papillomavirus, or HPV, the virus responsible for nearly all cervical cancers.

"Expanding access to screening is one of the most important steps we can take to prevent cervical cancer, and at-home HPV self-collection is a game changer for making screening easier to complete," Jeff Andrews, vice president of medical affairs at Waters Advanced Diagnostics, said.

Waters said it currently establishing partnerships to provide broader nationwide access to the Onclarity HPV Self-Collection Kit, which is expected to be available by prescription in the coming months. Covered by private insurance, Medicaid and Medicare, the kit can be mailed directly to a patient's home, allowing them to collect a sample and mail it to a laboratory for processing.

The kit is tested with the BD Onclarity HPV Assay, which detects all of the high-risk, carcinogenic genotypes of HPV, the company said.

Waters shares were down 1.2% in premarket trading at $303.65. The stock has fallen more than 20% over the last 3 months and is roughly flat on a year ago.

Write to Robb M. Stewart at robb.stewart@wsj.com

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April 08, 2026 08:48 ET (12:48 GMT)