MILFORD, Mass., April 8, 2026
Waters Corporation has announced U.S. FDA clearance for its Onclarity™ HPV Self-Collection Kit, enabling at-home cervical cancer screening and marking a major advancement in diagnostic accessibility and preventive healthcare. The approval includes the BD Onclarity™ HPV Assay, the most comprehensive HPV screening tool in the U.S., capable of detecting high-risk cancer-causing HPV genotypes with extended genotyping capabilities. This milestone is expected to significantly improve early detection rates and reduce barriers to routine screening.
At-Home Testing Expands Access to Cervical Cancer Screening
The newly approved self-collection kit allows patients to collect cervical samples at home and send them to laboratories for analysis, eliminating common barriers such as clinic visits, scheduling challenges, and patient discomfort. This innovation addresses a critical public health issue, as approximately 60% of cervical cancer cases occur in individuals who are unscreened or under-screened, highlighting the urgent need for more accessible screening solutions.
By enabling at-home testing, Waters aims to increase screening participation rates, particularly among underserved populations, and support earlier detection of cervical cancer risk. Early identification of HPV infections allows healthcare providers to intervene sooner, improving patient outcomes and reducing disease progression.
The kit is expected to be available by prescription and covered by private insurance, Medicaid, and Medicare, further enhancing accessibility and affordability for patients across the United States.
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Advanced HPV Assay Enhances Diagnostic Accuracy
The Onclarity™ HPV Self-Collection Kit is paired with the FDA-approved BD Onclarity™ HPV Assay, which offers extended genotyping to detect all high-risk HPV strains associated with cervical cancer. Unlike traditional screening methods, this assay can identify six individual HPV genotypes and three grouped categories, providing clinicians with detailed insights for risk stratification and patient management.
Samples collected using the kit are processed on the fully automated BD COR™ System, which utilizes advanced robotics to ensure high-throughput, accurate, and reliable results while preserving specimen integrity. This end-to-end automated workflow enhances laboratory efficiency and supports consistent diagnostic performance.
The development and validation of the self-collection approach were supported by collaboration with the National Cancer Institute (NCI) through the SHIP Trial, reinforcing the scientific credibility and clinical reliability of the technology.
Driving Preventive Healthcare and Health Equity
Cervical cancer is largely preventable through regular screening and early detection of HPV, the virus responsible for nearly all cases of the disease. However, traditional screening methods have faced challenges in reaching all populations, particularly those with limited access to healthcare services.
Waters’ at-home screening solution represents a transformational step toward improving health equity, enabling more individuals to participate in routine screening regardless of geographic or socioeconomic barriers. By providing convenient and accessible testing options, the technology supports a shift toward patient-centered care and preventive healthcare strategies.
The company is actively establishing partnerships to expand nationwide access to the self-collection kit, ensuring that more patients and healthcare providers can benefit from this innovation. This aligns with broader healthcare trends focused on early detection, personalized care, and improved patient engagement.
The FDA clearance of the Onclarity™ HPV Self-Collection Kit marks a significant milestone in cervical cancer prevention, combining advanced diagnostic technology with patient-friendly at-home testing to improve screening access and outcomes. By addressing critical gaps in screening participation and enabling earlier detection, Waters is contributing to a new era of accessible, efficient, and equitable healthcare solutions, reinforcing the growing importance of diagnostic innovation in modern medicine.
Source: Waters Corporation press release
