Dr. Jeff Andrews, VP, Medical & Scientific Affairs – BD Integrated Diagnostic Solutions

The goal of cervical cancer screening is simple but critical: To detect pre-cancer before it develops into cancer. Adding HPV at-home self-sampling to any cervical cancer prevention effort is close to a silver bullet; it’s simple, easy and safe for women, and equals doctor-collected samples in diagnostic qualityⁱ.

Persistent infection with HPV is the cause of virtually all cases of cervical cancerⁱⁱ. Current estimates indicate that every year in Europe, more than 61,000 women are diagnosed with cervical cancer and nearly 26,000 die from the disease,ⁱⁱⁱ making cervical cancer the second-most common female cancer deaths in women aged 15 to 44 and the ninth-most frequent cancer among women overall.ⁱⁱⁱ This is simply not acceptable.

Over half of all cervical cancers are diagnosed in women who have never been screened or have not been screened in the previous five years^iv, a situation that has been compounded by the global pandemic^v. HPV self-sampling makes screening accessible to women who don’t typically participate in screening or have limited access to screening.

At-home collection has the most significant potential to help address the urgent public health challenge of reaching people with a cervix who do not regularly attend or have access to routine cervical cancer screening.

The BD Onclarity™ HPV assay with extended genotyping received the industry’s first at-home self-collection claim for HPV screening (CE marked to the IVD directive 98/79/EC) and remains one of the few HPV assays approved for samples acquired using validated self-collection devices. Self-collection with the BD Onclarity™ assay is approved in countries accepting the CE mark. Self-collection at healthcare facilities, meaning that the patient is onsite and instructed by the clinician how to take the sample at the clinic setting, does afford the patient a degree of privacy. However, having to make an appointment, visit a clinic and then self-collect during the appointment is much less convenient and less private than being able to self-collect the sample in the comfort and privacy of one’s home (or wherever the patient chooses) and at whatever time is convenient for them.

Cervical cancer screening has been very effective at reducing morbidity and mortality from disease but participation in screening programs varies widely across Europe, ranging from 7.3% to complete coverage^vi. Adding at-home collection as an option to screening programs has been demonstrated to increase participation. ⁱ And by far, the greatest potential impact for reduction of cervical cancer incidence in the next two decades is reaching under-screened women; the ability to perform self-sampling outside of a health care facility is among the most valuable tools for that impact.

The BD Onclarity™ HPV Assay detects and identifies 14 high-risk human papillomavirus (HPV) types in a single analysis and provides genotyping information from specimens collected for cervical cancer screening purposes. The BD Onclarity™ HPV Assay includes genotype reporting beyond HPV genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58, 35/39/68 and 56/59/66.

Combining HPV self-sampling with extended genotyping allows for focus on those women at highest risk while not overtreating those at very low risk. Screening strategies, including at-home self-collection, that employ HPV tests with simultaneous genotyping offer a simple way to improve cervical cancer screening to the benefit of the woman and health care providers both by allowing risk stratification directly on the screening sample.

In late 2020, the World Health Organization (WHO) launched its Global Strategy to Accelerate the Elimination of Cervical Cancer, recognizing the potential for a three-pronged approach of vaccination, screening, and treatment to virtually eliminate cervical cancer^vii. The European Union has set a goal to introduce “organized population-based HPV-based screening and achieve 70% of screening coverage in the target age group, providing also HPV testing on self-samples for non-screened or underscreened women; and to manage 90% of screen-positive women” by 2030^viii. Self-collection, specifically at-home self-collection, has the potential to move the EU closer to that goal.

Laboratories and facilities can process the at-home self-collected samples via a BD diluent tube using the BD Onclarity™ HPV Assay on either the BD Viper™ LT or the BD COR™ System, both of which are in use globally.

The BD COR™ System, BD Onclarity™ HPV Assay and the BD Viper™ LT are in vitro diagnostic medical devices bearing a CE mark.

ⁱ Arbyn, M. et al. (2018) Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses. Bmj 363, k4823;
ⁱⁱ Cadman, L. et al. (2021) A randomised comparison of different vaginal self-sampling devices and urine for human papillomavirus testing - Predictors 5.1. Cancer Epidemiol Biomarkers Prev Published Online First on January 29, 2021; DOI: 10.1158/1055-9965.EPI-20-1226; Rohner, E. et al. (2020) Test Accuracy of Human Papillomavirus in Urine for Detection of Cervical Intraepithelial Neoplasia. J Clin Microbiol 58 (3) ⁱⁱⁱ Walboomers J, Jacobs M, Manos M et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999;189(1):12-19.
ⁱⁱⁱ Cervical Cancer Prevention Policy Atlas (EPF) 2020 https://www.epfweb.org/node/504#:~:text=Current%20estimates%20indicate%20that%20every,aged%2015%20to%2044%20years.
^iv CDC. Cervical Cancer is Preventable. 2014. https://www.cdc.gov/vitalsigns/cervical-cancer/index.html (Last accessed 3/23/2021)
^v 1 MMWR, delay or avoidance of medical care because of COVID. (n.d.). Retrieved October 28, 2021, from https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6936a4-H.pdf.
^vi Basu, P. et al. (2018) Status of implementation and organization of cancer screening in The European Union Member States-Summary results from the second European screening report. Int.J.Cancer:142, 44-56.
^vii https://www.who.int/news/item/17-11-2020-a-cervical-cancer-free-future-first-ever-global-commitment-to-eliminate-a-cancer
^viii Arbyn M. et al. (2021) The European response to the WHO call to eliminate cervical cancer as a public health problem. Int. J. Cancer. 2021;148:277–284.