Home / Health / Waters Corp. Unveils FDA-Cleared HPV Self-Collection Kit
Waters Corp. Unveils FDA-Cleared HPV Self-Collection Kit
10 Apr
Summary
- FDA approved Waters' Onclarity HPV self-collection kit for at-home use.
- The kit allows women earlier access to cervical cancer screening.
- It aims to improve health equity and reduce cervical cancer burden.
The US Food and Drug Administration (FDA) has approved Waters Corporation's Onclarity human papillomavirus (HPV) self-collection kit. This clearance is poised to significantly expand women's access to earlier cervical cancer screening. The BD Onclarity HPV Assay, now approved for at-home use, can identify all high-risk carcinogenic HPV genotypes. Waters acquired this assay as part of its July 2025 acquisition of Becton, Dickinson and Company's biosciences and diagnostic solutions division.
Patients can collect their own samples at home using the kit, which is then mailed to a lab for processing. The BD COR system automates analysis and reporting, with results communicated to healthcare providers to guide subsequent care. This advancement is expected to remove barriers to screening, advance earlier detection, and achieve greater health equity.
Research highlights that HPV causes nearly all cervical cancers, with a significant portion occurring in unscreened individuals. The World Health Organization (WHO) estimates that persistent HPV infection is attributable to 95% of cervical cancers if untreated. Waters' kit is entering a market with existing at-home screening tools, reflecting growing investor interest in women's health devices.
