FDA Clears At-Home HPV Self-Collection Kit to Expand Cervical Cancer Screening Access

The FDA has cleared the Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use, as tools for cervical cancer screening, according to a news release from Waters Corporation.¹

The regulatory milestone follows a collaborative effort with the National Cancer Institute (NCI) through the Cervical Cancer Last Mile Initiative to address significant barriers in preventative care. Human papillomavirus (HPV) is a significant driver of cervical cancer cases, yet the press release highlighted that approximately 60% of new diagnoses occur in individuals who are unscreened or under-screened. This decision expands upon prior regulatory momentum in 2024 and 2025, when self-collection was initially permitted only within healthcare settings such as primary care offices and pharmacies.

“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, MD, FRCSC, vice president of Medical Affairs, Waters Advanced Diagnostics, at Waters Corporation, stated in the press release.¹ “As a practicing obstetrician/gynecologist who has performed cervical cancer screenings for decades, I have seen firsthand the profound difference early detection makes for patients. When more patients can get screened, whether at home or in the clinic, clinicians have better information to identify risks earlier and intervene sooner. That allows us to spend less time trying to reach patients who have fallen behind on screening and more time focusing on prevention, follow-up care, and treatment for those who need it.”

The investigators noted that the HPV self-collection kit was tested with the BD Onclarity HPV Assay, which identifies all high-risk carcinogenic genotypes of HPV. It is the only FDA approved HPV assay that detects 6 individually and 3 groups of pooled results. Further, these samples are processed on the BD COR™ system. The accuracy and evaluation of self-collection for HPV testing was evaluated in SHIP trial (NCT06498661).

The SHIP trial was a multicenter, prospective study designed to evaluate the clinical accuracy of self-collection approaches. Patients were assigned to either group A, in which patients underwent self-collection of 2 vaginal samples and clinician collection of a cervical test sample, then standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated, or group B, in which patients underwent self-collection of 2 vaginal samples and clinician-collection of 1 or 2 cervical test samples, then possibly underwent colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures.

Eligible patients in both groups were 25 years or older with an intact cervix. In group A, patients had a referral for colposcopy or cervical excisional procedure in which routine cervical cancer screening included positive HPV testing or abnormal cytology performed within the past 12 months preceding the referral visit. In group B, patients were eligible for cervical cancer screening by current national guidelines.

The primary objective of the study was to evaluate the clinical accuracy for the detection of cervical precancer/cancer and agreement/concordance on self-collected vs clinician-collected samples for several HPV genotype detections and groupings. Exploratory objectives included human factors affecting usability, acceptability, and preferences for self-collection, among others.

“US 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 personalized care,” added Jianqing Bennett, senior vice president, Waters Advanced Diagnostics, Waters Corporation, in the press release.¹ “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.”

References

1. Waters announces FDA clearance of the most comprehensive at-home cervical cancer screening tool, the Onclarity HPV self-collection kit and FDA-approved HPV assay. News release. Waters Corporation. April 8, 2026. Accessed April 9, 2026. https://tinyurl.com/sauheyd
2. Self-collection for HPV testing to improve cervical cancer prevention (SHIP) trial (LMI-001-A-S01). ClinicalTrials.gov. Updated April 1, 2026. Accessed April 9, 2026. https://tinyurl.com/yc2sfjp3