971446CINck – a laboratory triage test for disease stratification to prevent cervical cancer.ClosedSmall Business Research InitiativeInnovate UKCINck – a laboratory triage test to prevent cervical cancer. Our vision is to produce a laboratory based triage test for cervical screening to improve stratification of women, infected with HPV, who are at very low risk of developing either cervical pre-cancerous disease or cancer from those who need clinical treatment. Cervical cancer is a devastating disease caused by certain types (High Risk types) of Human Papilloma Virus (HR-HPV). HR-HPV types are common and over 70% of sexually active men and women will be infected at some time. Unfortunately for women, if infection persists in cells of the cervix this can lead to cancer if untreated. However, nearly all infections are cleared naturally and cause no significant disease. Cervical screening prevents cancer by checking for pre-cancerous disease which can be treated in the clinic. Women in the UK are fortunate to have access to a nationally organised cervical screening programme and to vaccination against the two most common HR-HPV types. However, anyone over 27 has not been vaccinated and as cervical cancer can take decades to develop against all types that can cause cancer, there is a clear need to continue screening. Additionally, as the vaccine only protects against 2 out of 15 HR-HPV types it is unclear whether other types will in future expand within the population to cause more cervical cancers. Currently, UK cervical screening is done by “cytology” which means looking at cells taken during a cervical screening test under a microscope. Cytology is time consuming, costly, subjective and sensitivity varies dramatically between laboratories. As HR-HPV infection is necessary for cancer development it makes sense to switch from cytology to testing for HR-HPV which is done by a high-throughput, rapid, objective laboratory test. This type of screening, called HPV-First, has a sensitivity of >95% for detecting infection. It is the clear direction of travel for cervical screening and is being trialled in England, Italy , Sweden, Denmark, Norway and in Holland which will switch completely to HPV-First in 2016. The American Society for Colposcopy and Cervical Pathoogy also supports HPV first in women over 30. A negative HR-HPV result means a woman is at a <0.5% risk of cancer. The problem for the NHS is that HR-HPV infection will be detected in hundreds of thousands more women than are picked up by cytology. The majority of infected women have no cervical disease and the challenge is to stratify infected women into those who require clinical examination and those at extremely low risk of cancer who can be managed more conservatively. Our work shows certain protein markers are associated with clinically concerning infection and can be detected in the same samples used for cytology and HR-HPV testing. We have identified combinations of these proteins with high sensitivity and specificity for detecting cervical disease in infected women. Detection can be done as a high-throughput, rapid laboratory triage assay on a platform currently used in NHS laboratories. Our aims are to:- i) develop plans for trial of our triage test in NHS Lothian, and a spin-out company to exploit trial results; ii) evaluate impact of adoption of our test to identify how to progress through evaluation and adoption stages; and, iii) to generate commercially viable evidence for test performance and to refine the clinical care algorithm for risk stratification of HR-HPV infected women.