The clearance of the Onclarity HPV Self-Collection Kit and approval of the BD Onclarity HPV Assay aim to reduce barriers for unscreened populations.

The Food and Drug Administration (FDA) has cleared the Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use. This regulatory clearance aims to expand access to cervical cancer screening and remove barriers for individuals who do not receive routine screenings, according to a press release from Waters Corp.

Cervical cancer is largely preventable with regular screening and early detection of human papillomavirus (HPV), the virus responsible for nearly all cases. Approximately 60% of cervical cancer cases occur in individuals who are unscreened or under-screened. Public health experts have identified at-home self-collection as a strategy for improving early detection and reducing cervical cancer deaths.

“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,” says Jeff Andrews, vice president of medical affairs, Waters Advanced Diagnostics, Waters Corp, in a release. “When more patients are able to get screened, whether at home or in the clinic, clinicians have better information to identify risks earlier and intervene sooner.”

Laboratory Processing and Genotyping

The kit is tested with the BD Onclarity HPV Assay, which detects high-risk, carcinogenic genotypes of HPV. It is the only FDA-approved HPV assay to identify six individual and three groups of pooled results, which the company describes as the “most comprehensive HPV screening tool available in the US today.”

Samples are processed on the fully automated BD COR System, which uses robotics to prepare, analyze, and report results while preserving specimen integrity. Waters collaborated with the National Cancer Institute through the Cervical Cancer “Last Mile” Initiative SHIP Trial to evaluate the accuracy of self-collection for HPV testing.

“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,” says Jianqing Bennett, senior vice president, Waters Advanced Diagnostics, Waters Corporation, in a release.

Access and Distribution

Waters is establishing partnerships to enable nationwide access to the kit, which is expected to be available by prescription in the coming months. The screening kit can be mailed directly to a patient’s home, allowing them to collect a sample and mail it to a laboratory for processing. Results are shared with the patient’s healthcare provider to guide follow-up and care decisions.

The kit is expected to be covered by private insurance, Medicaid, and Medicare. This initiative is part of a broader effort to achieve greater health equity and reduce the burden of cervical cancer for women and persons with a cervix.

Photo caption: Waters announces FDA clearance of the Onclarity HPV Self-Collection Kit and approval of the BD Onclarity HPV Assay with extended genotyping for at-home use, marking a significant milestone in expanding access to cervical cancer screening.

Photo credit: Waters Corp

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