Cervical cancer is the second most common cancer in women worldwide, a position it shares with colorectal cancer - breast cancer being the most prevalent. About 400,000 new cases of cervical cancer are diagnosed each year, with a high proportion occurring among the economically disadvantaged, in both developing and industrialized nations. For the past 50 years, the standard detection method has consisted of the visual inspection of hundreds of thousands of cells per patient (morphology); looking for small changes in the shape and size of cells and nuclei in order to identify pre-cancerous and cancerous cells. This method is referred to as the Pap-Test, after its inventor, Dr G. Papanicolaou, who developed it in the 1940s.

In cervical cancer, early diagnosis is critical for a good prognosis and consequently early detection programs seek to identify both those at risk and those in the very early stages of disease. Worldwide, at least 140 million Pap smears are taken every year. With the implementation of prevention programs for early detection of morphological abnormalities in cervical cells the incidence rate of cervical cancer has decreased by about 70%.

Despite this great success, current early detection technologies and diagnostics for cervical cancer have well recognized limitations resulting in unacceptably rates of false negative, false positive diagnoses and high costs. This is because the tests used currently do not actually detect direct markers of disease resulting in a high degree of subjectivity.

More recently, testing for Human Papillomavirus (HPV) has been adopted for the management of unclear and mildly abnormal Pap Tests (most of which are false positive results). High-risk human papillomaviruses (HR-HPV) have been demonstrated to be the main etiological factor for the development of cervical cancer (see Figure 1). The use of HPV testing for this application is limited to a small percentage of all Pap Tests. HPV testing has superior sensitivity for disease compared to that of a Pap test. However, due to the high rate of HPV infection and prevalence in the general population (up to 30% of women) HPV testing delivers very low specificity (correlation of positive test to actual disease), which severely limits its potential utility to be used for early disease detection.