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Clinical Need for Cervical Cancer Detection

Cervical Cancer, cancer of the uterine cervix, is the second most common cancer among women worldwide, with an estimated 493,243 new cases and 273,505 deaths per year. These statistics are particularly troubling since when detected early, cervical neoplasia is almost always curable. Due to the magnitude of the public health problem, cervical cancer prevention is considered a priority by the World Health Organization (WHO).

Colposcopy is the primary diagnostic method used in the US to detect cervical intraepithelial neoplasia (CIN) and cancer, following an abnormal cytological screen (i.e. Pap smear).

The purpose of a colposcopic examination is to identify and rank the severity of lesions, so that biopsies representing the highest-grade abnormality can be taken, if necessary. A colposcopic examination involves a systematic visual evaluation of the lower genital tract (cervix, vulva and vagina), with special emphasis on the subjective appearance of metaplastic epithelium comprising the transformation zone on the cervix. However, there also is debate as to the predictive value of colposcopic exams as they are currently practiced.

The positive predictive value of a colposcopic impression for microinvasive cervical cancer is only 60%, and about 50% of microinvasive and 30% of invasive cancer was missed. Due to the subjective nature of the examination, the accuracy of colposcopy is highly dependent upon colposcopist experience and expertise.

Even in experts’ hands, colposcopy suffers from low specificity leading to many unnecessary biopsies. These avoidable biopsies cause an increased risk of infection, patient discomfort, delayed treatment and substantially increased costs.


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