US FDA approves Waters' at‑home cervical cancer screening kit
AOL.com • • health
Key Points:
- Waters announced FDA clearance for its at-home cervical cancer screening kit, designed for use with an approved HPV test to enhance early detection and reduce cervical cancer deaths.
- Approximately 60% of cervical cancers occur in individuals who are not screened or are screened less frequently than recommended, highlighting the need for accessible testing options.
- The self-collection kit, validated with BD's Onclarity HPV assay, allows patients to collect samples at home and mail them to a lab, with results shared with healthcare providers.
- Waters collaborated with the U.S. National Cancer Institute to verify the accuracy of home sample collection and plans to launch the kit nationwide by prescription in the coming months.
- The kit is expected to be covered by private insurance and federal programs including Medicare and Medicaid, facilitating broader access to cervical cancer screening.
