FDA Clears First Comprehensive At-Home Cervical Cancer Screening Tool

Waters Corporation announced that the FDA has cleared the Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use, marking what experts are calling a pivotal step toward eliminating longstanding barriers to cervical cancer screening.¹

A New Option for At-Home Screening

Waters collaborated with the National Institutes of Health National Cancer Institute through the Cervical Cancer ‘Last Mile' Initiative SHIP trial (NCT06498661) to evaluate the accuracy of self-collection for human papillomavirus (HPV) testing. The resulting product is now the most comprehensive at-home cervical cancer screening option currently available.^1,2

The BD Onclarity HPV Assay with extended genotyping is a multiplex real-time polymerase chain reaction (PCR) assay for the qualitative detection of 14 high-risk HPV types, providing on-demand genotyping for individual results of HPV 16, 18, 45, 31, 51, and 52, with pooled results of additional genotypes. The Onclarity assay is the first FDA-approved test that reports 6 HPV strains individually, enabling those strains to be tracked over time, an important determinant of cervical cancer risk for patients who test positive for HPV.^3,4

The kit is expected to be available by prescription in the coming months, with Waters currently establishing partnerships to enable broader nationwide access.¹

Why This Approval Matters

Cervical cancer screening disparities in the US are deeply concerning. African American women have a 30% higher cervical cancer incidence rate and a 70% higher mortality rate than White women. The age-adjusted cervical cancer mortality rate among Black women is approximately 1.5 times that among White women, and when corrected for hysterectomy rates, the mortality rate ratio reaches 2.2.^5,6

Despite its life-saving potential, cervical cancer screening remains inaccessible to many individuals in underserved communities, with barriers including geographical isolation, cultural and linguistic challenges, and socioeconomic factors hindering accessibility. At-home self-collection has long been proposed as a solution.⁷

With vaginal self-collection as an option, women are more inclined to participate in screening, with never-screened women demonstrating a more than 2-fold increase in acceptance and participation, allowing health care providers an alternative option to identify high-risk HPV infections in more convenient care settings.⁴

From Clinic to Home: The Evolution of Self-Collection

This clearance builds on earlier regulatory progress. In May 2024, the FDA expanded approvals for 2 primary HPV tests—the Onclarity HPV assay and the cobas HPV test—to include self-collected vaginal specimens obtained in health care settings, such as primary care offices, urgent care centers, pharmacies, and mobile clinics.⁸

At the time of those 2024 approvals, data from the SHIP trial were being gathered with the eventual goal of extending limited approvals to home-based sample collection. That goal has now been achieved with this latest FDA action.⁹

The updated American Cancer Society cervical cancer screening guideline now incorporates self-collected vaginal specimens, a method of primary HPV testing, and recommends repeat screening every 5 years for those with a negative test result.⁸

Role of the Pharmacist

With the Onclarity Self-Collection Kit expected to be available by prescription, pharmacists are well positioned to counsel patients on proper self-collection technique, the significance of HPV genotyping results, and the importance of follow-up care after a positive result. Screening is only one piece of the full prevention pathway: If a test detects cancer-causing HPV, additional visits to a health care provider may be needed to determine whether precancerous cells require treatment. Pharmacists can help ensure patients understand that a positive HPV result is not a cancer diagnosis but a prompt for further evaluation.⁹

Studies demonstrate that programs incorporating HPV self-collection can increase cervical cancer screening among under-screened patient populations, and community pharmacy settings may be an especially powerful access point for patients who face traditional barriers to gynecologic care.⁵

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 8, 2026. https://ir.waters.com/News--Events/newsroom/news-details/2026/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/default.aspx

2. Self-collection for HPV testing to improve cervical cancer prevention (SHIP) trial (LMI-001-A-S01) (SHIP-A-S01). ClinicalTrials.gov. Updated April 1, 2026. Accessed April 8, 2026. https://clinicaltrials.gov/study/NCT06498661

3. BD Onclarity HPV Assay. BD. Accessed April 8, 2026. https://www.bd.com/en-us/products-and-solutions/products/product-families/bd-viper-lt-system

4. Women in US can now collect their own sample for cervical cancer screening. News release. BD. May 15, 2024. Accessed April 8, 2026. https://news.bd.com/2024-05-15-Women-in-U-S-Can-Now-Collect-Their-Own-Sample-for-Cervical-Cancer-Screening

5. Perkins RB, Wolf AMD, Church TR, et al. Self-collected vaginal specimens for human papillomavirus testing and guidance on screening exit: an update to the American Cancer Society cervical cancer screening guideline. CA Cancer J Clin. 2026;76(1):e70041. doi:10.3322/caac.70041

6. Reynolds S. FDA approves HPV tests that allow for self-collection in a health care setting. National Cancer Institute. July 24, 2024. Accessed April 8, 2026. https://www.cancer.gov/news-events/cancer-currents-blog/2024/fda-hpv-test-self-collection-health-care-setting

7. Farajimakin O. Barriers to cervical cancer screening: a systematic review. Cureus. 2024;16(7):e65555. doi:10.7759/cureus.65555

8. Draft recommendation: cervical cancer screening. US Preventive Services Task Force. December 10, 2024. Accessed April 8, 2026. https://www.uspreventiveservicestaskforce.org/uspstf/draft-recommendation/cervical-cancer-screening-adults-adolescents

9. Folino G, Zent I, Eason L, et al. Temporal trends of cervical cancer demographics: a CDC WONDER database study. Front Oncol. 2025;15:1567305. doi:10.3389/fonc.2025.1567305