FDA Clears Onclarity HPV Self-Collection Kit to Expand Cervical Cancer Screening Access
In a significant move to combat cervical cancer, the U.S. Food and Drug Administration (FDA) has cleared the Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay for at-home use. Announced on April 8, 2026, by Waters Corporation, this regulatory milestone aims to remove critical barriers that prevent many individuals from receiving routine screenings.
Cervical cancer is largely preventable through regular screening and the early detection of human papillomavirus (HPV), the virus responsible for nearly all cases. Despite this, approximately 60% of cervical cancer cases occur in individuals who are either unscreened or under-screened. By introducing an at-home collection option, public health experts believe early detection can improve and cervical cancer deaths can decrease.
Breaking Barriers to Early Detection
Traditional clinic-based screenings can present logistical or personal barriers for many. The introduction of the Onclarity HPV Self-Collection Kit allows patients to collect their own samples, making the process more accessible. This shift is designed to reach the high percentage of the population currently missing routine care.
“Expanding access to screening is one of the most important steps we can accept to prevent cervical cancer, and at-home HPV self-collection is a game changer for making screening easier to complete,” stated Jeff Andrews, M.D., vice president of medical affairs at Waters Advanced Diagnostics. He noted that when more patients get screened—whether at home or in a clinic—clinicians gain better information to identify risks earlier and intervene sooner.
The Technology: BD Onclarity HPV Assay
The self-collected samples are tested using the BD Onclarity HPV Assay, which is described as the most comprehensive HPV screening tool available in the U.S. Today. This assay provides extended genotyping to detect high-risk, carcinogenic genotypes of HPV.
Key technical features of the assay include:
- Comprehensive Identification: It is the only FDA-approved HPV assay capable of identifying six individual genotypes and three groups of pooled results.
- Automated Workflow: Samples are processed on the fully automated BD COR System.
- Precision Robotics: The BD COR System uses robotics to prepare, analyze, and report results, which helps preserve the integrity of the specimen.
Key Takeaways
- FDA Status: The Onclarity HPV Self-Collection Kit is FDA-cleared, and the BD Onclarity HPV Assay is FDA-approved for at-home use.
- Target Population: The tool specifically targets the 60% of cervical cancer cases that occur in unscreened or under-screened individuals.
- Clinical Advantage: The assay offers extended genotyping and utilizes an automated robotic system (BD COR) for processing.
- Goal: To reduce cervical cancer risk by expanding nationwide access to screening.
Frequently Asked Questions
How does the Onclarity HPV Self-Collection Kit work?
Patients use the kit to collect a sample at home, which is then tested using the BD Onclarity HPV Assay. This removes the require for an initial clinic visit for sample collection, reducing barriers to screening.
What makes the BD Onclarity HPV Assay “comprehensive”?
It is the only FDA-approved assay that can identify six individual HPV genotypes and three groups of pooled results, providing a detailed look at high-risk, carcinogenic HPV types.
Why is at-home collection important?
Since a majority of cervical cancer cases occur in people who do not receive regular screenings, providing an at-home option makes it easier for under-screened populations to detect HPV early, when the disease is most preventable.
Looking Ahead
Waters Corporation is currently establishing partnerships to ensure broader nationwide access to the Onclarity HPV Self-Collection Kit for both patients and prescribers. This initiative marks a pivotal step toward eliminating the gaps in cervical cancer screening and improving long-term patient outcomes through earlier intervention.