Updates and announcements
NEW CLINICAL STUDY ON HPV SELFY PUBLISHED
The results of a clinical study on HPV Selfy, a screening test for the prevention of cervical cancer and Ulisse BioMed's flagship product, 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).
This 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 self-sampling kit was sent home to these women; self-sampling is an innovative way of collecting a biological sample that is widely supported by the World Health Organisation and is useful for increasing cervical cancer screening coverage. The study just published documents a very high adherence to this project: in fact, as many as 80% of the women returned the self-sampled swab to the hospital where it was tested with the HPV Selfy test, one of the few validated tests for screening even on self-sampled samples.
This high participation rate is particularly relevant as similar studies have reported much lower return rates of between 6 and 39.1 per cent. The authors of the study hypothesise that this success can be attributed to the fact that the women were informed by the health authority of the initiative by means of a personalised telephone call that provided detailed explanations on the procedure and clarified any doubts about it. The kit sent out was also developed to be as user-friendly as possible, to ensure that each woman could use it properly. The swab used, produced by Copan Italia, is the only one in the world validated for home self-testing and, besides being very easy to use, is absolutely painless. The results of a questionnaire, put to the women at the end of the study, were also very encouraging: the majority of the women expressed an extremely positive opinion of the self-sampling, considering it easy to perform, and in general of the procedure offered by the health authority.
Ulisse BioMed has also developed a complete line of CE-IVD-labelled 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.