Cervical Cancer Screening
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 and false positive diagnoses and high costs. This is because tests in current use have a high degree of subjectivity and do not actually detect direct disease markers.
More recently, testing for Human Papilloma Virus (HPV) has been adopted for the management of unclear and mildly abnormal Pap Tests (most of which are false positive results) for women over 35. High-risk human papillomaviruses (HR-HPV) have been demonstrated to represent the main etiological factor for cervical cancer (see Figure 1). The use of HPV testing for this application is limited to a small percentage of all Pap Tests. The sensitivity for disease of HPV testing is superior to that of a Pap Test. However, the high rate of general HPV infection for this group of viruses in women (up to 25%) delivers a very low specificity (correlation of positive test to actual disease), which severely limits the potential clinical utility of this for mainstream early detection.
Figure 1. Persistent infection with high risk HPV over a number of years is known to be causative of cervical cancer.
There exists a medical need for far greater objectivity in disease early detection over current approaches which are related on subjective, morphological interpretation of cervical cells or for risk assessment based on presence of HPV. A more efficient approach to cervical cancer early detection and diagnosis is to detect specific biomarkers that indicate the presence or absence of cervical cancer or its pre-cursors. mtm has identified mtm has identified p16INK4a as a marker with the potential as a direct marker and has developed a family screening and diagnostic technologies based on the p16INK4a biomarker. Diagnostics and early detection technologies based on this marker provide the promise for confident and accurate early diagnosis of disease. mtm's diagnostics kits make use of the clinically validated E6H4™ antibody clone, which is highly selective and sensitive to the presence of p16INK4a. Unlike other antibody candidates, detection with E6H4™ does not show cross reactivity with Trichomonas (a protozoal infection of the vagina). This cross-reactivity renders other antibody candidates unacceptable as generating too many false positives.
The first of these products, CINtec® Histology and CINtec® Cytology have been available on a global basis since January 1, 2007. The GMP manufactured kit components in combination with the optimized antibody ensures the reproducible quality and results in assessing a wide variety of biological specimens.
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