Untreated, long-lasting infections of the cervix from the human papillomavirus (HPV) cause 95% of cervical cancer cases. This scary reality makes early detection of cervical cancer, through HPV/Pap testing of women and people with uteri every three or five years after age 25, absolutely critical, but many fail to follow this advice, some through no fault of their own.
If doctors diagnose cervical cancer, catching it at an early stage, they can effectively treat it by removing all or part of the cervix. Other cases may require removal of the uterus (a hysterectomy), part of the vagina, or lymph nodes. A Pap smear test screens for DNA from certain types of HPV, including types 16 and 18. However, according to the US Centers for Disease Control and Prevention, doctors diagnose about half of all invasive cervical cancer cases in people who have never had a screening, and about 10% of their diagnoses are in people who have not had an HPV/Pap test in the five years prior to their diagnosis.
Screening has been shown to save lives, so why don’t more people take this important step? Some likely refuse to get tested, or delay the screening, due to the discomfort, intimacy, and invasiveness of the procedure: it requires them to visit a gynecologist’s office; lie flat on their backs, spread their legs and place their feet in stirrups; wince at the insertion and rotation of a cold, hard metal speculum and at its pinch; and endure the swabbing and removal of collected cells and the speculum. This can be quite painful for people over age 50 because with increased age, vaginal tissues shrink and become less elastic. Ethnic minorities are also less likely to get screened due to cultural prohibitions, mistrust, and/or embarrassment.
Good news, however, has just arrived: the FDA has approved a simple, accurate, do-it-yourself test that people can do in the privacy of their homes or in their doctor’s office, if they so prefer. Roche Diagnostics and Becton-Dickinson manufacture the screening kit, and its availability comes just in time, as the world’s population and the number of high-risk women over 65 continue to increase.
The DIY Cervical Cancer Screening kit that is mailed out to patients includes a self-collection swab in a tube; easy-to-read, understandable, illustrated instructions; and a return envelope and pre-addressed label.
Two UK clinical trials of the game-changing, cervical-cancer screening test paved the way for the FDA’s approval. Dr. Anita Wey Wey Lim conducted them at the Comprehensive Cancer Centre’s School of Cancer and Pharmaceutical Sciences, based in the Faculty of Life Sciences and Medicine at King’s College in London in 2021 as reported in the British Journal of General Practice and in 2024 in The Lancet. These research trials involved self-sampling by older women and by women who had ceased to participate in HPV/cervical cancer screenings.
Dr. Lim’s first study focused on older women and included an intervention group and an equal-size control group of those who did consent to traditional HPV exams with specula in their doctors’ offices. Participants in the intervention group chose either to self-sample at home— using a vaginal swab instead of a speculum—or to go to their doctor’s office, where the clinician did the sampling using the swab from the kit. The study results showed greatly increased uptake in screening among those lapsed attendees, both with at-home and in-office types of swab sampling, compared with the traditional speculum-based control group. The real-world study design incorporated diverse ethnicities and income levels.
Her second study offered self-sampling kits to women who were overdue for screening, sent from the offices of their general practitioner, and, like the first study, included underserved, ethnically varied minorities. The DIY, self-sampling kits produced a highly encouraging 22% increase in tests by the lapsed-screening population per month. Participants received invitations from their doctor’s office to order the kits, and the offices also sent kits directly to non-responders. Half the women who mailed back samples for analysis had not gotten screenings for two years; some had never gone in for a screening.
Remarkably, large numbers of ethnic minorities willingly participated in both of Dr. Lim’s self-sampling studies. This game-changing result suggests that formerly unreachable populations with the greatest need for responsible, equitable care can easily benefit from this cancer screening. As with the traditional exam, patients with positive HPV test results get referrals to their physicians for additional testing, including a repeat HPV test.
A United Kingdom women’s health company, looking to the future, is piloting another technology for detecting cervical cancer cells on slides from women who have already tested positive. This new test uses a digital cytology system to digitize images of cervical smear slides from HPV-positive women. It also uses an algorithm to identify the cervical cancer cells and to separate out the most diagnostically relevant ones in the sample. The benefit of this technology is that it eliminates nontransformed cells and therefore cuts down on the number of cells the cytotechnologist needs to analyze. Because of this increase in efficiency, the technology will speed up doctors’ diagnoses and allow them to more easily and more quickly diagnose difficult cases.
Jue Wang, Yunfang Yu, Yujie Tan, Huan Wan and Nafen Zheng, researchers from Guangzhou, China, contributed to a study published in Nature about an AI-based cervical cancer screening capable of classifying cancer cells. These five researchers trained their Artificial Intelligence Cervical Cancer Screening technology on many different datasets comprising a total of 16,056 participants. It showed higher accuracy in classifying cervical cancer cells than that achieved by cytopathologists who presently manually inspect and grade slides. The new computer technology does not eliminate manual inspection: It augments it with AI, providing more accuracy. The researchers’ report boasts a significant 13.3% increase in accuracy and sensitivity using the new technology, compared with just using the manual method. The published research does report limitations — situations in which the cervical sample may not accurately represent the true state of the cervix, which can lead to a false negative result.
Dr. Dimitra Pouli, Irene Georgakoudi, and colleagues at Tufts University have reported research on a potentially noninvasive method that uses a type of light technology to image cervical cancer cells from fresh biopsies. This technique captures fluorescence, light that absorbs at a non-visible wavelength and emits at a visible wavelength, to identify enzymes that are more prevalent in cancer cells than in normal ones that are needed for cellular metabolism. This ultra-sensitive technique, used in combination with examining the morphology of the cells in the biopsy, can aid in diagnosis. This work is preliminary, but the researchers hope that doctors can use the technology, called functional metabolic imaging, to improve identification of cancers in a patient’s body—or in vivo— without the need for a biopsy. If the translation to in vivo is successful for functional metabolic imaging, patients can avoid the pain, inconvenience, and delay of biopsy results with no loss of screening accuracy or sensitivity. This new test can be performed at the patient’s bedside.
All these advances in cervical cancer screening mark a promising, new era for women and people assigned female at birth especially ethnic or religious minorities who have long faced inequitable health-care access and outcomes. Researchers expect that these new often pain-free tools will result in earlier diagnosis, will help women overcome their fears about screening procedures, and will lead to better prognosis.
Roberta Batorsky, a longtime AWIS member, is a former college biology instructor and cancer pharmacologist, now a freelance writer. She writes for publishers such as Pearson, McGraw-Hill, and Cengage/Brooks/Cole, as well as for the National Center for Science Education, and she has taught biology in a maximum-security prison in New Jersey.
This article was originally published in AWIS Magazine. Join AWIS to access the full issue of AWIS Magazine and more member benefits.