Cervical Cancer Awareness Month: Expanding Access for Cervical Cancer Screening Using Self-Sampling | Mark H. Einstein, MD, MS, FACS, FACOG

Mark H. Einstein, MD, MS, FACS, FACOG

The SGO’s Cervical Cancer Task Force chaired by me and my co-chair, Deanna Teoh, MD, MS, has been focused on addressing the multifactorial health equity and policy aspects to decrease the incidence of invasive cervical cancer in the US, including coverage for diagnostic testing and treatment of pre-invasive disease. The inclusion of primary HPV testing as the American Cancer Society’s preferred method for cervical cancer screening has allowed for expansion of opportunities for cervical cancer screening through highly sensitive HPV testing using self-swabbing. Recently, two of the commercially available HPV tests in the US market now also have a labeling for self-sampling in office settings.^1,2

Such technology opens the door for new, previously nontraditional approaches and clinical settings for cervical cancer screening. Imagine an office visit where in addition to ‘leaving urine’ in the bathroom during an office visit intake, a patient can also leave a self-sampled cervical cancer screening specimen for primary HPV testing. Imagine traditional primary medical physician visits, urgent care visits, or emergency room visits for completely unrelated issues, now being an opportunity of convenience for cervical cancer screening. Sadly, many individuals diagnosed with cervical cancer in the US have seen a medical provider in the past five years, but were not screened for cervical cancer. Self-sampling can be implemented to overcome this unfortunate issue in an impactful way.

Home or ‘over the counter’ solutions for primary HPV screening are becoming the community standard in other high-income countries such as the Netherlands, UK, and Australia/New Zealand. The testing, workflow for labs, and linkage to access to care is now under study in the US. In an effort overseen by the Division of Cancer Prevention at the US National Cancer Institute, in close oversight by the US Food and Drug Administration (FDA), such home-based solutions are now under study in an effort called the Last Mile Initiative (LMI-SHIP Trial).³ In this study, the performance of commercially available HPV tests that are FDA approved for primary HPV testing for cervical cancer screening are being studied for their performance, implementation, and also eventual access to care for those who have screened ‘positive’ and need further management (e.g., colposcopy or active surveillance for ‘intermediate risk’ testing). Such technology can also be triaged with already FDA-approved molecular tests for triage to colposcopy such as Dual Stain (CINtec®Roche Diagnostics) allowing for a completely molecular ‘Pap.’ without the need for cytology or a provider-obtained traditional cervical cytology needed to perform high quality triage of an individual for further management, such as colposcopy. Such technology has the promise to:

1) be used for home cervical cancer screening, which can be impactful for poor access communities (e.g., rural US),

2) overcome additional barriers to access to prevention due to jobs, childcare, or eldercare (cervical cancer is the cancer most closely linked with poverty in the US)⁴

3) improve adherence to active surveillance for equivocal testing (e.g., post-LEEP follow-up and other frequent repeat testing strategies that are sooner than every 3-5 years)

For individuals who already have a diagnosis of cervical cancer, the Cervical Cancer Task Force is working to increase access to appropriate treatment, including immune checkpoint inhibitors and brachytherapy where relevant. I am sure the SGO membership and our survivor groups would welcome the day when someone does not need to suffer from cervical cancer again. Adding innovative delivery of care and access tools such as self-sampling to our prevention strategies can help us to achieve this goal.

References

1. BD Onclarity™ HPV Assay [package insert]. Sparks, MD: Becton, Dickinson and Company; 2018.

2. Roche cobas® HPV Test [package insert]. Pleasanton, CA: Roche Molecular Systems, Inc.; 2011.

3. National Cancer Institute Division of Cancer Prevention. NCI Cervical Cancer ‘Last Mile’ Initiative. Accessed on December 11, 2024. https://prevention.cancer.gov/major-programs/nci-cervical-cancer-last-mile-initiative 4. Spencer JC, Brewer NT, Coyne-Beasley T, Trogdon JG, Weinberger M, Wheeler SB. Reducing Poverty-Related Disparities in Cervical Cancer: The Role of HPV Vaccination. Cancer Epidemiol Biomarkers Prev. 2021 Oct;30(10):1895-1903. doi: 10.1158/1055-9965.EPI-21-0307. Epub 2021 Sep 9. PMID: 34503948; PMCID: PMC8492489.

Mark H. Einstein, MD, MS, FACS, FACOG, is a gynecologic oncologist at Montefiore Medical Center and Co-chair of the SGO Cervical Cancer Task Force.