Research group that wants to eradicate cervical cancer
29 September 2021
Eradicating cervical cancer is the driving force behind the self-sampling and testing concept developed by a research group at the Department of Immunology, Genetics and Pathology. After extensive studies, the HPVir concept is ready to be used on a larger scale.
For 20 years, the research group at the Department of Immunology, Genetics and Pathology (IGP) has been working on the development of HPVir, a combined self-sampling kit and HPV test. The test is designed to detect whether a woman is infected with the HPV virus and thus at greater risk of cervical cancer.
“We have been working on this concept for a very long time, so there has been a large number of studies over the years to make sure it works,” says Ulf Gyllensten, Professor at IGP and leader of the research group that developed HPVir.
“Initially, we conducted small-scale studies. We had a number of women collect a sample themselves during a visit to a doctor, which was followed by the doctor performing a supplementary assisted sample collection,” explains Inger Gustavsson, project manager of the research group.
With assisted sample collection, cells are collected from the cervix (portio vaginalis) and studied under a microscope or tested for the HPV virus. With self-sampling, vaginal secretions are tested instead, and the focus of testing is the HPV virus only. In the comparative studies, the doctor also collected a tissue sample from the cervix to look for cell changes that could be a precursor to cervical cancer.
Self-sampling and testing concept does not miss any cell changes
The results of the initial studies were positive.
“There was very good consistency of HPV results between the sample collected by the woman and the one collected by the doctor. We actually found more HPV types in the vaginal secretion sample that the woman collected herself,” says Inger Gustavsson.
After the initial studies, the research group concluded that the self-sampling and testing concept does not miss any serious cell changes, and continued to test the concept in larger studies.
“Another factor that was important for us to ensure was that the results were consistent over time. We therefore had a number of women performing the self-sampling and testing every day for one month,” says Inger Gustavsson.
Half of the women in the group had a hormonal variation due to their menstrual cycle, which could affect the vaginal secretion. The other half of the group was older women without the same hormonal influence.
“We saw that the results were consistent and were not influenced in any way by hormonal fluctuations of the menstrual cycle or by the woman being menopausal or postmenopausal,” explains Ulf Gyllensten.
36,000 women in Uppsala study
Once the research group had ensured alignment with assisted sampling and the consistency of the results over time, they moved on to larger studies. Over the three years that the study ran in Uppsala County, 36,000 women were invited to participate.
The aim was to compare the self-sampling and testing concept with the existing procedure in the county – cell sampling with assisted sampling in accordance with the screening programme. The women who tested positive for HPV when using the self-sampling and testing concept repeated the self-test after more than four months. If they were still HPV positive, they were referred for subsequent examination by a doctor.
“The results of the study showed that HPVir found twice as many women with serious cell changes,” explains Inger Gustavsson.
Ulf Gyllensten leads the research group that developed HPVir. In addition to the fact that HPVir has been shown to be better at detecting cell changes, he also sees other benefits from self-sampling.
“Today, more than 20 percent of women do not participate in cancer screening for various reasons. Our studies show that more women would participate in self-sampling and testing, which would give us better coverage,” he explains.
Innovation in the FTA card
The health economic analyses performed on HPVir also show that it is much cheaper. The healthcare sector could save up to 50 percent of the current costs of screening. It saves on primary care costs as well as transport and staff costs. This means that more women can be tested.
“The current screening programme stops testing women after the age of 64. This means that a large group of older women who actually have an increased risk of cervical cancer are missed,” says Ulf Gyllensten.
Cervical cancer is most common among women aged 30–40 and after the age of 70.
The innovation of HPVir is not only that the woman collects the sample herself, but also the use of a special FTA card for testing. The woman applies her vaginal secretion to the FTA card, and the card clearly indicates that the secretion has adhered. The samples are then stable at room temperature for several years. Samples on the card are transmission-proof, which means that those handling the card cannot be infected by any other viruses that might be present in the sample.
“This means that the FTA card could be highly useful in countries where the HIV virus is widespread,” says Ulf Gyllensten.
The simpler and cheaper method also makes it easier for developing countries to perform the sample collection.
Moral responsibility as researchers
HPVir is now a registered trademark. The research group’s next step is to get HPVir CE-marked. CE-marking represents health, environment and safety, and means that the manufacturer certifies that the product complies with the EU’s basic health, environmental and safety requirements. This is a new law that came into force in May 2021. For a product to be CE-marked, there must be a company behind the product – a new world for most researchers. However, Inger Gustavsson and Ulf Gyllensten agree that this is the future.
“We want to save more lives, and are really passionate about the use of HPVir,” says Ulf Gyllensten.
“CE-marking is the only way to reach out, and it is our moral responsibility as researchers to get this out to the public,” says Inger Gustavsson.