Jeff Andrews, MD, FRCSC, discusses BD’s new HPV self-collection device

In a recent interview with Contemporary OB/GYN, Jeff Andrews, MD, FRCSC, Vice President Medical Affairs, Diagnostic Solutions, at BD, discussed current challenges and potential advancements in cervical cancer screening, with a focus on under-screened populations and self-collection human papillomavirus (HPV) testing.

Andrews identified the primary challenge as reaching the 30% of women and people with a cervix in the United States who are under-screened or have never been screened. These individuals are disproportionately from underserved communities, contributing to stagnant cervical cancer rates. Traditional clinical screenings using a speculum can be a deterrent becuase of issues such as lack of insurance, transportation, time off work, or past trauma. To address these barriers, Andrews emphasized the need for self-collection options that allow patients to screen at home, increasing accessibility and comfort.

He introduced BD’s new self-collection HPV testing method, which has been submitted to the FDA for approval. This procedure allows a clinician to order a test that is mailed to the patient’s home. The patient collects their sample using a simple swab, seals it in a tube, and returns it by mail. In the lab, the sample is processed using BD’s automated Core system, which runs a DNA PCR test called Onclarity. A unique feature of this test is its extended HPV genotyping, which enables precise follow-up steps based on the HPV type detected.

Depending on the results, clinical management aligns with ASCCP guidelines:

• If negative, re-screening is recommended in 3 years.
• If positive for HPV 16 or 18, immediate referral for colposcopy is advised.
• For other high-risk genotypes, follow-up includes either repeat testing in 1 year or cytology, based on the specific type.

Andrews explained that this approach helps overcome common barriers to screening by eliminating the need for in-person visits and speculum exams. He stressed that the self-collected test must be as effective as clinician-collected samples, a claim supported by their studies submitted to the FDA.

Finally, Andrews noted that self-collection is already part of ASCCP guidelines and included in the draft recommendations of the US Preventive Services Task Force. He expressed hope that organizations such as ACOG will fully endorse the method, as it expands access to care and ensures earlier detection and treatment, ultimately benefiting both patients and OB/GYN providers.

No relevant disclosures.

Reference

BD aims to save lives by empowering women with choice and access to cervical cancer screening self-collected at home. BD (Becton, Dickinson and Company). July 31, 2025. Accessed August 5, 2025.