Advancements in Cervical Cancer Screening

January marks cervical cancer awareness month. Most cases of cervical cancer are caused by persistent infection with particular strains of human papillomavirus[1], (HPV).  This means that, unlike most cancers, cervical cancer can be prevented from developing, such as through vaccination and early treatment.  Around 3,200 women are diagnosed with cervical cancer every year in the UK[2].  Cervical cancer has a 5-year survival rate of 91% for early-diagnosed cancer, dropping down to 60% for more advanced cancer, [3] so regular screening is vital to increase the chance of early detection.

In 2020, the world health organisation launched the Cervical Cancer Elimination Initiative, with the goal of eliminating cervical cancer as a public health problem by 2100[4].  To aid in reaching this goal, three key targets have been laid out to be implemented in every country by 2030.  These targets are:

• Vaccination: 90% of girls should be vaccinated with the HPV Vaccine by the age of 15.
• Screening: 70% of women should be screened using a high-performance test by the age of 35 and again by the age of 45
• Treatment: 90% of women with precancer should be treated and 90% of women with invasive cancer should be managed.

In the UK, only 68.8% of eligible individuals aged 25 to 64 were adequately screened in the three and a half years leading up to March 2024.  NHS data suggests that about a third of women in the UK miss their cervical cancer screening due to concerns around pain, embarrassment and body consciousness.[5]

Recent advancements in cervical cancer screening may help in reaching these targets to reduce cervical cancer rates, some of which are discussed below.

Teal health

Figure 1 US 1,021,130 S

Teal health have developed a device – the Teal Wand – which is currently under review with the FDA.  This will allow for women to collect their own samples at home and post them to a lab for processing.  The results are then sent to the user, and they can be connected with a Teal Health provider to discuss next steps.  If necessary, the Teal team can help coordinate further follow-up care.

Teal health have a granted US patent for their device (US 12,089,823 B2) and have pending applications in a number of other countries.  Additionally, they have a US design patent (USD 1,021,130 S) which protects the appearance of the Teal wand.

Daye

Daye sell diagnostic tampons that allow for at home collection of a sample that can be used for the screening 14 of HPV strains.  The tampons are inserted for at least 20 minutes when the user is not menstruating, and then can be sent off to one of Dayes labs where the sample will be tested using PCR testing techniques.  The results are then sent to the user, and Daye offer advice and support for those who have tested positive for a strain of HPV.  As the diagnostic tampons are designed to be used when the user is not menstruating, the tampons provide a convenient way for all women, including post-menopausal women, to access HPV testing at home.

Matrix health and care

Figure 2 https://femtechinsider.com/matrix-health-and-care-patent/

Matrix have developed a digitally-enabled device intended to replace the use of speculums in gynaecological examinations.  The device can be inserted by the user and is designed to be a more comfortable alternative to the traditional speculum.  The device is equipped with multispectral cameras to capture high-quality diagnostic images; these results can be instantly relayed to a clinician.  A swab can be placed in the device to allow for collection of a screening sample.  The cameras can be utilised along with an actuator in the device to maneuver the swab into the correct position, by either the user or by a healthcare provider.  To reduce any self-consciousness the cameras are designed to only turn on once the device is inserted into the vaginal canal and automatically turn off when the device is removed.

Matrix have a granted US patent for their device (US 11,864,738 B1).

Papcup

Figure 3https://femtechinsider.com/papcup-cervical-cancer-screening-menstrual-blood-testing/

Sânziana Foia, a post graduate student, developed a device, the Papcup, that can detect HPV from the comfort of your own home.  A swab is used to self-collect a sample of menstrual blood which is then placed into the device where biosensors in the device test the levels of the HPV Virus in the sample.  The test can also be used with a shallow vaginal swab, meaning that the device can also be used by people who don’t menstruate.  The device returns the results in just 15 minutes.  Not only would this device allow for at home-testing, but the quick results may also reduce the level of anxiety that some women may experience whilst waiting to receive the results.

Hologic

Hologic have developed the first FDA cleared digital cytology system that combined the use of advanced volumetric imagine technology with artificial intelligence to identify pre-cancerous legions and cancerous cervical cells.  Cervical cancer cells are traditionally analysed by a pathologist or cytopathologist by carefully reviewing each of the cells under a microscope.  The Genius Digital diagnostic system images the cells on the slide and their AI model highlights specific cells that need review by the pathologist.  Hologic report a 28% reduction in false negatives of high grade squamous intraepithelial and more severe lesions when using this system compared to traditional microscopic review[6]. The reduction in false negatives helps to reduce the number of cases of cervical cancer that go undetected.  In these cases, treatment can begin earlier, and chances of survival will increase.

Hologic have filed a patent application (WO2023164664A1) for multi-plane viewing of a digital image of subject matter, which does not require accessing multiple images of the subject matter taken at multiple image planes, one possible application of this technology is in cervical cancer screenings.

Conclusion

Eradicating cervical cancer relies on widespread HPV vaccination, regular screening and early treatment.  However, many women face barriers to accessing cervical cancer screening, including discomfort, embarrassment and time constraints.  Advancements in at-home testing and self-testing, help to break down barriers that prevent women from accessing cervical cancer screening, as these tests may provide a more comfortable and less embarrassing experience than a traditional smear test.  At-home testing also avoids the need to attend in person appointments, which some women may find preferable.  By increasing the number of women participating in cervical cancer screening, and with improved testing accuracy, it is hoped that occurrences of cervical cancer can be detected and treated earlier, thus reducing mortality rates.