Transforming cervical cancer protection with the BD Onclarity HPV Assay

In a recent interview with Contemporary OB/GYN, Jeff Andrews, MD, FRCSC, vice president of medical affairs at BD Life Sciences, discussed advancements in human papillomavirus (HPV) screening, particularly focusing on challenges, innovations, and the importance of self-collection methods.

Andrews noted that approximately 25% of eligible women in the United States are under-screened or unscreened for HPV, leading to a disproportionately high cervical cancer incidence in underserved and marginalized communities, such as Black, Hispanic, rural, and LGBTQ individuals. To address these disparities, self-sampling techniques have been introduced, initially in health care facilities, with the potential to expand to at-home self-collection in the future.

The BD Onclarity HPV Assay plays a significant role in broadening HPV screening. Approved by the FDA, this assay includes extended genotyping, which differentiates HPV types based on risk levels. This precision enables targeted follow-up care, where individuals with high-risk genotypes such as HPV 16 or 18 can proceed directly to colposcopy, while those with lower-risk genotypes may only require retesting after 12 months. This tailored approach minimizes unnecessary clinical visits while ensuring timely intervention for high-risk cases.

Andrews also discussed the Su Clinica program in southern Texas, a region with high cervical cancer rates and low insurance coverage. Su Clinica collaborates with federally qualified health centers to offer self-collection as a practical solution, especially since many of these centers lack full-time ob-gyn availability. Patients can privately collect samples, which are then sent to labs for testing using the BD Onclarity Assay. This initiative not only provides opportunistic screening but also serves as a model for scaling the self-collection workflow nationwide.

The program emphasizes communication in English and Spanish, clear instructions with visual aids, and streamlined processes to ensure collected samples are efficiently analyzed and results are communicated. The study evaluates how to optimize patient follow-up, particularly for those requiring additional diagnostic procedures. The goal is to refine and replicate the program's successes in other regions to reduce cervical cancer disparities across the United States.