The value of HPV self-sampling kits


Jeff Andrews, MD, FRCSC, Vice President of Medical Affairs for Integrated Diagnostic Solutions at BD, discusses the link between human papillomavirus (HPV) and cervical cancer, and how HPV self-sampling kits may increase rates of cervical cancer screening.

The value of HPV self-sampling kits | Image Credit: © Chinnapong - © Chinnapong -

The value of HPV self-sampling kits | Image Credit: © Chinnapong - © Chinnapong -

Contemporary OB/GYN: What is the current state of cervical cancer in the United States? Have you seen an increase or decrease in diagnoses?

Jeff Andrews, MD, FRCSC: Despite being one of the few cancers that is almost entirely preventable, according to the American Cancer Society (ACS), every year in the United States, 14,000 women are diagnosed with cervical cancer, and more than 4,000 women die from it. The annual incidence of cervical cancer has not declined in decades. However, cervical cancer is one of the most curable cancers in the United States today. The annual incidence of cervical cancer has not declined in decades.

Cervical cancer is caused by the most common sexually transmitted infection, human papillomavirus (HPV). However, findings from a survey of 872 U.S. women ages 18-64 years old, conducted by the Harris Poll on behalf of BD, found that 67% of American women were unaware that cervical cancers are caused by HPV.

The FDA-approved quadrivalent HPV vaccine that debuted in 2006 has proven to be highly effective at decreasing the prevalence of high-risk HPV types 16 and 18. Since then the newer nonavalent vaccine has been in use. Although high vaccination rates will one day lead to a decline in cervical cancer, we need screening tests today and for the next 3 decades to reduce cancer incidence. The state of the science is that HPV screening is more sensitive than traditional Pap screening (visualizing cells on a slide).

Contemporary OB/GYN: What barriers prevent women from being screened for cervical precancer?

Andrews: Women often face cultural, economic, and geographical barriers that preclude them from obtaining critical, sometimes lifesaving health screenings, including HPV and Pap tests for cervical precancer.

Equitable access to health care is critical. Cervical cancer rates – and deaths – especially among women in low- and middle-income countries and in high-income countries among marginalized groups are disproportionate. According to the American Journal of Preventive Medicine, Hispanic and Black women have less access to screenings, and many times, sociocultural factors at play are precluding them from getting regular screenings.

Cervical cancer screenings can save women’s lives, but we must do better to provide access to the right resources, tools, and information women need to better manage their personal care. Effective, accessible screenings will empower women, and ultimately, work towards eliminating cervical cancer in our lifetime.

Contemporary OB/GYN: Can you talk about the pros and cons of at-home HPV self-collection tests?

Andrews: The FDA has not approved self-collection for HPV testing at the time of this answer. Self-collection is currently available in other countries and provides more choices and greater control over the process, which will hopefully lead to early detection and prevention of HPV and other pre-cancerous diagnoses. For some women, options like a self-collection test that enables them to collect a specimen in the comfort and privacy of their own home could be a way forward to improve health equity.

Self-sampling would be cost-effective in the United States, and ultimately, could drive access to under-served communities. It makes screening accessible to women who don’t typically participate in screening or have limited access to screening.

Self-sampling doesn’t take away from a clinician’s role, in fact, it can improve clinicians’ efficiency. The advantage of self-collection is that it eliminates the need for an initial in-clinic pelvic speculum examination and can be performed at home, or another location that is convenient for the patient. However, clinicians still need to be involved in the process – from creating the orders and managing the follow-ups. Those with positive HPV results need to be seen by a clinician for follow-up care.

Contemporary OB/GYN: What HPV self-collection options are available for women in the United States?

Andrews: Self-sampling is already in place outside the United States. where there are organized screening programs. Self-sampling is available in Australia, Denmark, Sweden, and many parts of Europe. It provides more choices and greater control over the process, which will hopefully lead to early detection and prevention of HPV and other pre-cancerous diagnoses.

The BD Onclarity HPV assay with extended genotyping was the industry’s first HPV test CE marked for at-home self-collection for HPV screening and, to our knowledge as of today, remains the only HPV assay CE marked for use in settings outside of healthcare facilities.

Contemporary OB/GYN: Is there anything you would like to add?

Andrews: According to a recent survey commissioned by BD by Harris Poll, 79% of American women say they would be interested in using a self-collection kit for HPV or cervical cancer screening, especially if they could do it in private, at a time and place where they are most comfortable.

BD has been working in public-private partnership in the United States to promote the idea that self-sampling would be an advantage for women in the United States. In addition, organizations like the American Cancer Society are joining with the White House Cancer Moonshot to promote educational outreach to women, awareness about HPV screening, and to encourage the adoption of self-collection for primary HPV screening.

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