The US Food and Drug Administration cleared the Onclarity human papillomavirus (HPV) self-collection kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use, increasing access to cervical cancer screening options.
Cervical cancer is preventable with routine screening and early identification of HPV, which is associated with nearly all cases. Despite established screening recommendations, approximately 60% of cases occur among patients who are unscreened or under-screened, indicating ongoing barriers to access and adherence. At-home sample collection has been identified by public health experts as an approach to improve screening participation.
The self-collection kit enables patients to obtain a sample outside a clinical setting and submit it for laboratory analysis. Testing is performed using the BD Onclarity HPV Assay, which detects high-risk carcinogenic genotypes and provides extended genotyping results, including individual identification of six genotypes and grouped reporting of three additional categories. The assay is processed on the BD COR System, an automated platform designed to support standardized specimen handling, analysis, and reporting.
Evaluation of self-collected samples was conducted in collaboration with the National Cancer Institute through the Cervical Cancer Last Mile Initiative SHIP trial. According to company representatives, expanding screening methods may support earlier identification of patients at risk and facilitate timely follow-up and management.
The kit is expected to become available by prescription in the coming months and is anticipated to be covered by private insurance, Medicaid, and Medicare. It can be mailed directly to patients, with results transmitted to health care providers to guide subsequent care decisions.
Waters indicated that it is establishing partnerships to expand access to the self-collection kit across the US, with the aim of increasing screening uptake and supporting earlier detection of cervical cancer.
Source: Waters
