Cervical Specimen Self-Collection Is Finally Here

Michelle Nelson, MD
Posted on September 30, 2024

Related AFP Editorial: It Is Time to Switch to Primary HPV Screening for Cervical Cancer

Each year, 14,000 people in the United States are diagnosed with cervical cancer, and 4,000 will die from it. Almost all cases are linked to carcinogenic genotypes of the human papillomavirus (HPV). Current methods of cervical cancer screening include Papanicolaou testing with or without HPV co-testing. The HPV test is 90% sensitive for identifying cervical precancers. A previous AFP editorial advocated for primary HPV screening over co-testing in average-risk individuals because of equal effectiveness, decreased cost, increased accessibility, and the limit of number of lifetime tests required.

On May 14, 2024, the U.S. Food and Drug Administration approved the expanded application for HPV detection kits, including BD Onclarity and Cobas HPV test from Roche. Previously, only cervical specimens collected by a clinician in a health care setting were approved for HPV testing. These tests can now be used by patients for vaginal self-collection in a health care setting if cervical sampling is contraindicated or unable to be obtained by a clinician.

According to the National Cancer Institute’s Cancer Trends and Progress Report, only 72.4% of eligible women 21 to 65 years of age in the United States were up-to-date with cervical cancer screening in 2021. In this same age range, Hispanic and non-Hispanic Black patients had lower completion rates at 67.9% and 71.6%, respectively. Lower screening rates in these populations occur for several reasons, including socioeconomic factors, lack of access to primary care, cost, fear of cancer diagnosis, disability, pain, preference for a female physician, time, and lack of transportation.

Other countries (e.g., Australia, Denmark, the Netherlands, Sweden) have already implemented self-sampling. Some countries have gone further and offered an at-home option to increase cervical cancer screening rates. Researchers in Denmark found that by offering an alternative to clinician-collected cervical cancer screening, 17% of eligible women who were not up-to-date on their screening completed the at-home self-sampling test.

The next logical step in the United States is at-home HPV screening for cervical cancer. The National Cancer Institute is currently conducting a clinical trial assessing effectiveness of self-collection methods through the Self-Collection of HPV Testing to Improve Cervical Cancer Prevention (SHIP) trial network. This study is part of the Last Mile initiative, which aims to provide access to cervical cancer screening to all eligible patients.

One of the best methods for preventing cervical cancer is the 9-valent HPV vaccine, which reduces the risk of cervical cancer by approximately 90%. Combining vaccination and increased access to HPV screening has been shown in other countries to reduce the incidence of cervical cancer. Expanding screening options for patients could reduce health disparities through improving early detection of cervical cancer.