Results of a clinical study regarding HPV Selfy, a screening test for cervical cancer prevention and a flagship product of Ulisse BioMed, have just been published in the prestigious international peer-reviewed scientific journal European Journal of Medical Research (https://eurjmedres.biomedcentral.com/articles/10.1186/s40001-023-01263-8).

That publication details the clinical trial conducted by the Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) in Trieste, where 500 women were enrolled whose screening test scheduled for 2021 had been postponed due to the SARS-CoV-2 pandemic. A vaginal specimen self-sampling kit was sent home to these women; self-sampling is an innovative mode of biological specimen collection widely supported by the World Health Organization, useful in increasing cervical cancer screening coverage. The just-published study documents very high adherence to this project: in fact, as many as 80 percent of women returned the self-reported swab to the hospital where testing was conducted with the HPV Selfy test, one of the few validated tests for screening even on self-reported samples.

Such a high participation rate is particularly relevant because similar studies have reported much lower return rates, between 6 and 39.1 percent. The study authors speculate that this success can be attributed to the fact that women were informed by the Health Authority of the initiative through a personalized phone call that provided detailed explanations of the procedure and clarified any doubts about it. The kit sent, moreover, was developed to be as user-friendly as possible to ensure that each woman could use it properly. The swab used, manufactured by Copan Italia, is the only one in the world validated for home self-sampling and, besides being extremely easy to use, is absolutely painless. The results of a questionnaire, posed to the women at the end of the study, were also very encouraging: the majority of the women expressed an extremely positive opinion towards the self-sampling, considering it easy to perform, and in general of the procedure offered by the Health Company.

Ulisse BioMed has, as well, developed a complete line of CE-IVD-labeled products for HPV detection and genotyping that allow the identification of up to 30 HPV genotypes in a single test constituting the widest range of products for HPV genotyping based on real-time PCR technology.