Introduction

AUTOCAST - The future of cervical cancer screening

Cancer accounts for nearly one-quarter of deaths in the developed world, exceeded only by heart diseases. One of the key strategies in cancer prevention is early diagnosis through cancer screening programs. Estimates of premature deaths that could be avoided through cancer screening vary from 3% to 35%, depending on a variety of assumptions. Beyond the potential to reduce mortality, screening may reduce cancer morbidity, since treatment for earlier-stage cancers is often less aggressive than that for more advanced-stage disease. Currently many cancer screening programs, have issues in relation to false negative/ positive results, long time delays in obtaining results and delays in starting treatment.

In this project, we will develop a novel low cost automated real time PCR/probe technology, in a microarray biochip format with corresponding automated detection instrumentation for use as a rapid “point of care” diagnostic device in both a clinical and laboratory setting.

image

Cervical cancer and its associated virus, Human Papilloma Virus (HPV) is the model system which will be used to develop this novel automated cancer screening technology. Cervical cancer is the second most common cancer in women worldwide, and remains a major cause of morbidity and mortality. HPV is implicated in over 99% of cervical cancers. Over 100 Human Papillomavirus (HPV) types have been identified, of which 40 types have been shown to infect the genital tract. HPV contributes to neoplastic progression through the interaction of its two oncoproteins E6 and E7 which interfere with critical cell cycle regulatory process, leading to over production of tumour suppressor genes, including p16INK4a. The uniqueness of the current project is the potential of the novel real time PCR technology to detect panels of multiple biomarkers, both viral and host cell markers, within a single test.
This will impact enormously on current cervical screening programs particularly in the context of HPV vaccination. Incorporation of these biomarker panels into cervical screening programs will have the potential to stratify patients based on their HPV subtype, defining different treatment cohorts, resulting in improved patient management and reduced costs to healthcare providers.

The developed system and assay technology can not only be used in the medical field for cancer research and diagnostics, but will also be applicable for food safety, environmental monitoring or homeland security if a suitable biomarker panel is adopted. The applicability and performance of the developed prototype system will be demonstrated in particular by screening for human papillomavirus viruses (HPV) biomarkers in cervical cancer.

The interdisciplinary consortium includes four research institutes and three industrial companies (two of which are SMEs), who have together extensive experience in all relevant fields ranging from HPV diagnostics using PCR based assays to polymer micro fabrication techniques. The companies involved cover the supply and value chain completely, and they are determined to commercialize the results. The consortium will be supported by a hospital carrying out validation of the system performance and comparing it with routine clinical tests. By doing this, it is assured that the requirements of the end-users are met and also the basic research in the field of cervical cancer is advanced.

image
image