Cervical cancer is the fourth most frequent cancer in people with a cervix, and in 2018, the World Health Organization (WHO) estimated there were over 500,000 cases, representing approximately 6.6% of all female cancers. According to the American Cancer Society (ACS), 14,000 women are diagnosed with cervical cancer yearly in the US alone, and more than 4,000 women die from it. Due to the high incidence of cervical cancer, the WHO has highlighted an urgent need for effective screening programmes.
However, cervical cancer is one of the most curable cancers. “We can end cervical cancer”. That was the leading 2023 message of the WHO, which runs an annual campaign to mark Cervical Cancer Awareness Month. Every January, the campaign puts a brighter spotlight on cervical cancer and human papillomavirus (HPV) vaccination. Alongside the campaign’s key 2023 message, the WHO encouraged people to “get informed, get screened, get vaccinated”.
The message reflects the sentiments across the healthcare industry as understanding, research and innovation into cervical cancer causes, detection and testing grow. The impetus to ensure early detection and treatment is advancing technological developments. New launches seek to improve screening and help healthcare clinicians and patients move towards a world where eliminating cervical cancer is the reality.
Pap and HPV testing confusion
Education is vital as new research reveals a lack of cervical cancer knowledge. An online survey conducted by research company The Harris Poll found a significant gap in women’s knowledge about the primary causes of cervical cancer and the most effective means of prevention. The Harris Poll was conducted among 872 US people aged 18 to 64 and captured responses relating to screening, equity and self-sampling.
The survey’s results reveal that the majority of those asked did not know when to get tested, signalling the necessity for precise and transparent information and guidance on cervical cancer screening. Further, many of those asked did not know the difference between a Pap and a HPV test.
In the US, several organisations make cervical cancer screening guidelines, contributing to a lack of clarity. “There are different recommendations on what age to start screening, how long a person should go between the screenings and with what method to [conduct] screens,” says Molly Broache, Associate Director, US Region, Medical Affairs at BD Life Sciences – Integrated Diagnostic Solutions.
HPV testing on its own can occur, as can a Pap test, which is sometimes called cytology. HPV and Pap tests can also occur together, which is called co-testing. “This can also contribute to confusion for both patients and providers,” says Broache.
Over four-fifths (81%) of people are unaware of how often to get a Pap test and 71% of respondents have delayed getting a Pap test, the survey found. Specifically, 15% of those asked said their visit for a routine care or check-up was more than three years ago, with nearly one in 10 (9%) saying they have never had a Pap test.
Over half of the women asked (51%) are unaware of how often to get an HPV test. While we have come to expect unknowns with many cancers, cervical cancer is different, as in over 99% of cases, HPV will be its cause. “So through vaccination and screening, we could remove cervical cancer in our lifetime,” says Broache.
Clinicians have identified that high-risk HPV can be prevented by early vaccination, ideally at 11 to 12 years old. However, regular screening is highly beneficial for people who have been exposed because it takes a long time for HPV or high-risk HPV to progress into cervical precancer and cancer. Therefore, if people are going for regular screenings, there is the opportunity for providers to catch HPV and perform the necessary treatment.
The survey results underscore that a lack of knowledge is one of the most significant barriers to receiving timely cervical cancer screening. Emerging tech seeks to fill that gap.
Inequity in testing, insurance and support
Health disparities limit access to and understanding of Pap and HPV testing, The Harris Poll’s survey finds, with Black, Latina and Hispanic people disproportionately affected.
“Racial and ethnic minorities, rural residents, sexual and gender minorities and those with limited English proficiency often face cultural, economic and geographical factors that preclude them from obtaining critical health screenings, including Pap and HPV tests,” says Broache.
Over 10% of Black and Latina women had never had a Pap test, for example, compared to 5% of white women. The survey also found that Hispanic people are more likely to say they were embarrassed or afraid that visiting an obstetrics and gynaecology clinician (OB/GYN) would hurt. The results show that Hispanic people are more likely to indicate they don’t have health insurance than non-Hispanic white women or live too far away from health care providers.
At-home testing technologies help to re-imagine the idea of healthcare and its typical setting. Tech provides a self-sampling opportunity for cervical cancer screening to take place in a comfortable environment, lessen the inequity barriers, and empower people to engage in regular cervical cancer screening.
“We need more patient-centred communications to educate everyone, including and especially marginalised and underserved groups, in addition to providing greater access to critical diagnostic tools and services,” Broache adds.
Challenges with traditional tools
“The ability to sample tissue in the cervical canal has been done similarly for many decades,” says Kathy Lee-Sepsick, Founder, President & CEO at Femasys.
Traditional cervical cancer screening tools focus on the endocervical canal. If there is an abnormal Pap smear, the patient will typically undergo an invasive procedure called a colposcopy, which includes a visualisation of the cervical cancer and tissue sampling. For decades, traditional tools, like brushes or a Kevorkian curette, have been the only ones available to collect tissue.
“The tools available to collect this tissue are limited and can cause pain and extreme discomfort, often resulting in an inadequate or contaminated sample,” says Lee-Sepsick.
Failing to take a tissue sample can lead to the patient having to return for repeat examinations and diagnostic care or more invasive procedures. To avoid the repeat of this procedure, doctors may perform a loop electrosurgical excision procedure (LEEP), which involves removing a portion of the cervix, which can lead to complications with later pregnancies or mean the person is unable to have instruments passed back into the uterine cavity.
Entering a paradigm shift
Biomedical company Femasys identifies areas of women’s healthcare with “very antiquated technologies”, says Lee-Sepsick. These are areas with limited advancements and considerable opportunity to develop women’s health-focused products, of which it believes cervical cancer screening is one.
Today, health tech innovators are developing tools to make cervical cancer screening more effective. Femasys has recently launched FemCerv, an endocervical tissue sampler to support clinicians and patients with cervical cancer screening. Femasys’ endocervical tissue sampler is the first FDA-cleared cervical cancer screening device designed to obtain a high-quality tissue sample to detect precancer or cancer lesions on the cervix.
By improving tissue quality and quantity, the creator has produced its new tool to enhance the existing standard of care. FemCerv aims to do this by capturing a 360-degree tissue sample from the cervix, allowing for comprehensive analysis and reduced contamination risk, and may also detect high-grade lesions or invasive cancer that other methods may not detect.
Global medical company BD wants to expand access to cervical cancer screening through self-sampling. The company launched its Onclarity HPV Assay for self-collection in 2021 in the European market. The technology tests for high-risk HPV with extended genotyping. BD’s screening assay specifically tests for HPV 31, a genotype that poses a very high risk for cervical cancer. BD created this type of test because, Broache confirms, it saw a “deficit in the HPV world of tests that were available to look at types other than 16 and 18”.
New clinical tools such as FemCerv can help generate more awareness around the importance of early detection of cervical cancers to enable treatment and, ultimately, its elimination. “Earlier detection always wins,” says Lee-Sepsick. To be able to identify, track and redo these types of patient samples is much better medicine.
The Harris Poll study found that 79% of US people asked would be interested in using a self-collection kit for HPV or cervical cancer screening, especially if they could do this in private, at a time and place where they are most comfortable. A self-collection kit is an alternative form of screening that allows women to collect their own specimens at home.
Self-sampling resonates with younger generations, signalling how at-home collection can give people choice and empowerment over their cervical cancer testing and overall healthcare decisions.
Younger women said they are more likely to use self-collection for HPV or cervical cancer because it might be less expensive (38% versus 28% of women ages 45 to 64), the Harris Poll reveals. A lack of insurance coverage is also an influence, with younger women stating they don’t have health insurance (18% versus 8% of women ages 55 to 64). Worries over pain also contributed to their decision, with younger women citing that a self-collection kit might hurt less than a traditional Pap test (21% vs 9% of women ages 45 to 64).
“The key to eliminating cervical cancer is prevention,” says Broache. “So we must increase knowledge, reduce stigma, raise awareness to help educate women worldwide and right here in the US,” Broache shares. Along with the screening, improving vaccine equity among young girls and boys and improving access to cervical cancer screening for under-screened and underserved women is vital. “Self-collection is our pathway forward there,” Broache adds.
Emerging diagnostic landscape: Still hurdles to overcome
As new technologies for cervical cancer screening are in their infancy, accessible and affordable screening is a significant consideration. FemCerv has, for example, intentionally introduced its product to the market at a low price point to enable widespread adoption. “I anticipate that physicians will want to add something that’s less painful and gets a more accurate comprehensive answer,” says Lee-Sepsick.
From aggregating the results of its survey, The Harris Poll researchers identified self-sampling as a cost-effective approach that will ultimately drive access to under-served communities across the US.
“It is available in other countries now, 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,” says Broache.
Adopting a self-sampling process in the US would see individuals receive a kit at home, collect the sample and send it back in a pre-addressed envelope to the laboratory. Then, a healthcare provider would receive the person’s results and confirm whether a follow-up visit is required.
Several factors can influence a person not wanting to have a cervical cancer screening, including a history of trauma and transportation or childcare difficulties. “Essentially, we must be able to get that FDA approval for self-sampling.”