The high-risk human papillomaviruses (HR-HPVs) are the etiologic agents of cervical cancer and are associated to anal and oropharyngeal cancers. The presence of HPV infection in the mouth may increase by 20 times the risk of developing oropharyngeal carcinomas.
The E6 and E7 oncoproteins are responsible for the onset and maintenance of carcinogenesis induced by HR-HPVs. They represent appropriate targets for the development of diagnostic tools.
In particular, the HPV16 E6 protein has been identified as an early biomarker for some HPV-associated oropharyngeal cancers (whose incidence is rising): E6 seropositivity was found to be present more than 10 years before the diagnosis of tumor.
We have developed a novel procedure to obtain the E6 protein from HPV16 and HPV18 in a stable, soluble, and biologically active form. We propose the early diagnosis of HR-HPVs-associated tumors through the development of novel diagnostic kits based on the identification of the E6 and E7 oncoproteins of the different HR-HPVs ("HPV-protein Chip"), able to distinguish self-resolving HPV infections from infections that are progressing to cancer.
Currently, the HPV diagnosis is based exclusively on molecular biology tests. A product for oncoproteins detection, such as a "HPV-protein Chip", could be a valuable tool for the second level of diagnosis in early HR-HPV cancers screening (HPV-test and / or PAP test), simple for clinical laboratories use.
Cervical screening is performed in all women aged between 25 and 64 years and a second level of diagnosis can improve the follow-up of positive women is not yet of clinical use for the lack of laboratory tests that can to give more information. The "HPV-protein Chip" could fill this gap.
The possibility of using kits for the detection of antibodies against HPV oncoproteins could provide important information for diagnosis or best treatment in a number of other cancers associated with HPV, such as cancers of the anal region and oropharyngeal.