The US Food and Drug Administration (FDA) has cleared Waters Corporation’s Onclarity human papillomavirus (HPV) self-collection kit in a development anticipated to expand women’s access to earlier cervical cancer screening.
Waters’ BD Onclarity HPV Assay with extended genotyping has also received FDA-approval for at-home use. Approved initially in 2018, BD Onclarity detects all of the high-risk, carcinogenic HPV genotypes. Waters asserts that it is the only FDA-approved HPV assay to identify six individual and three groups of pooled results.
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Waters inherited BD Onclarity following its $17.5bn acquisition of Becton, Dickinson and Company’s (BD) biosciences and diagnostic solutions division in July 2025.
Once patients have taken a vaginal swab with the Onclarity self-collection kit, which can be mailed directly to a patient’s home, samples are sent off for processing at a lab with BD COR. This system uses robotic-based protocols to prepare, analyse, and report results while preserving specimen integrity. The test results are subsequently shared with a patient’s healthcare provider to guide follow-up and care decisions.
Covered by private insurance, Medicaid, and Medicare, Waters said that it is currently establishing partnerships to enable broader nationwide access to Onclarity and expects the kit to be available by prescription in the coming months.
Jianqing Bennett, senior vice president of Waters Advanced Diagnostics, said: “FDA clearance of the Onclarity Self-Collection Kit for at-home use marks a meaningful step towards removing today’s primary barriers to screening and supporting more personalised care.
“We’re proud to provide this kit to advance earlier detection, achieve greater health equity, and ultimately reduce the burden of cervical cancer for women and persons with a cervix.”
Research indicates that HPV, a common group of over 200 related viruses, is responsible for nearly all cervical cancers, with approximately 60% of cervical cancer cases occurring in individuals who are unscreened or under-screened. According to the World Health Organization (WHO), if left untreated, persistent HPV infection of the cervix is attributable to an estimated 95% of cervical cancers.
Waters kit and assay are not the first at-home screening tools for cervical cancer to be made available in the US. With a similar setup, women’s health company Teal Health gained FDA approval for its Teal Wand device in May 2025.
GlobalData analysis reveals that medical devices and in vitro diagnostics (IVDs) for women’s health conditions are steadily attracting more investor interest across areas including female cancers, urinary incontinence, and pelvic floor disorders. According to GlobalData analysis, medical devices receiving approval for indications associated with women’s health are on the rise, with over 140 such devices approved in 2024 versus around 80 in 2020.
