The SMEs MIKROGEN and BIOSYNEX are well established in the field of diagnostic tests for infectious diseases in humans and perform active research into innovative products. As a critical step to get access to the lucrative market of diagnostic kits for the detection of persistent infections by human papillomaviruses (HPV), the SMEs teamed up with partner UIBK who developed a unique set of immunological tools suitable for this purpose, and two leading European gynecological clinics with longstanding interest in improving clinical management of HPV-associated diseases. Currently used diagnostic tools can detect HPV DNA in cervical smears but fall short of discriminating between transient infections which can spontaneously regress and persistent infections, which have a high chance to progress to high-grade squamous intraepithelial lesions. At this point, the PIPAVIR consortium comes in with the proposal to develop and validate a new diagnostic test for progressive infectious diseases that allows detection, by sandwich-ELISA, of HPV E7 proteins in cervical smears, as markers specific for persistent infections with bad prognosis. In addition, it is planned to develop and validate a diagnostic test strip for rapid detection of viral E7 proteins in cervical smears, most appropriate for alternative diagnostic procedures, such as self-sampling, as well as for the use in low-resource settings. As a major innovative feature, both proposed products use as molecular markers virus-encoded proteins closely related to infection-associated pathology, rather than just the presence of viral DNA or any surrogate markers. Based on the potential of the technology to meet a real clinical need, it can be anticipated that the ability of the participating SME partners to provide and market such superior diagnostic tools will create great business opportunities.
Fields of science
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