18 May 2022
Ulisse BioMed is proud to announce an important milestone reached: the validation of HPV Selfy as a primary cervical cancer screening test. To date, more than 250 HPV CE IVD marked tests are available on the market for the diagnosis of HPV but only about a dozen are validated for primary screening according to the relevant international guidelines: HPV Selfy - invented, patented, validated and CE- IVD marked by Ulisse BioMed - has been recognized as one of these.
This qualification is attested by a recently released international publication with 36 authors from a dozen international universities and institutes (among which, first and foremost, the Oncological Reference Center of Aviano, the Giuliano Isontina Health Authority (ASUGI) of Trieste, the Campus Biomedico of Rome, the University of Trieste, the Rudor Boskovic Institute of Zagreb and the International Center for Genetic Engineering and Biotechnology). The article, published in the prestigious peer-reviewed journal "Journal of Translational Medicine" (https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-022- 03383-x) shows the results of an extensive clinical study based on the analysis of samples collected over about a thousand women, enrolled at the Oncological Reference Center of Aviano and at ASUGI. The results obtained fully satisfy the international criteria (the Meijer guidelines - https://pubmed.ncbi.nlm.nih.gov/18973271/) to be met to define an HPV test as for
primary screening purposes, i.e. to ensure that the test has adequate quality, performance and reproducibility to be used on a large scale to prevent cervical cancer.
But that is not all: the test was also validated for primary screening on self-collected samples, according to specific international guidelines (VALHUDES protocol - https://pubmed.ncbi.nlm.nih.gov/30195193/), just like only two other tests validated for primary screening. Self-sampling is an innovative way of biological samples collection that is getting growing attention all over the world. Self-sampling, which can be performed easily in the privacy of the woman’s home, allows to increase the participation rate to primary screening programs and constitutes a powerful tool to effectively run the screening, even in times of severe restrictions, such as those encountered during the COVID-19 pandemic.
In addition to these distinctive characteristics, what makes HPV Selfy unique is the native genotyping capability of the test - thanks to the proprietary patented SAGITTA technology – able to provide the single genotyping of each viral strain detected in the biological sample. HPV Selfy is currently the only CE-IVD marked screening test, also validated on self-collected samples, able to offer such information about the genotypes responsible for the infection.
Genotyping rightly represents the new frontier of screening tests as only the knowledge of the specific genotype responsible for the infection (which can be more or less dangerous) can contribute to develop targeted and sustainable patient triage strategies - as underlined several times during EUROGIN 2022, the largest conference about cervical cancer prevention, where the work was presented (https://www.ulissebiomed.com/it/news/ulisse-biomed-partecipa-a- eurogin-2022/28). The ability to identify the genotype responsible for the infection allows to design new primary screening algorithms based on the oncogenic risk associated with the different HPV types. Furthermore, the specific knowledge of the genotype responsible for the infection allows to monitor the persistent infections of one of the high-risk HPV types and the co-infections that increase the probability of developing pre-cancerous lesions and, ultimately, cervical cancer.
"We worked with passion and dedication to achieve this result - says Rudy Ippodrino, Chief Scientific Officer - and the validation obtained confirms the unique performance of the test, a fundamental milestone for its commercialization".
Ulisse BioMed also developed a complete product line of CE-IVD marked tests for HPV detection and genotyping that allow to identify up to 30 HPV types in a single test: the widest product range of HPV genotyping tests based on real-time PCR technology.