With New Cervical Cancer Screening Technology, Women Can Be More Confident About Their Cervical Health (NAPS)—Most women are familiar with the Pap smear. In fact, George Papanicolaou’s “Pap” smear has been the preferred method of cervical cancer screening for more than 50 years. What most women do not realize, however, is that someclinical studies suggest that, when used alone, the Pap test is only 41 percent sensitive. PapSure is a new screening technology in the quest for early detection of cervical cancer, which is marketed by Watson Pharmaceuticals, Inc. PapSure combines the results of a traditional Pap smear and speculoscopy (a visual examination of the cervix) using Speculite, a disposable, chemiluminescentlight for vaginal illumination, which helps physicians visually identify cervical abnormalities or lesions that may be potentially cancerous. PapSure gives women and physicians more peace of mind by more than doubling the detection rate in cervical cancer screening to 92 percent compared to 41 percent for Pap smear alone. Although PapSure detected significantly more disease than the Pap smear alone, the increase in sensitivity was accompanied by an expected decrease in specificity from 95 percent to 80 percent. It also has a 99.1 percent negative predictive value, meaning that if a woman’s PapSure exam is negative, she has a less than one percent chance of having cervical abnormalities or potentially cancerouslesions. The Pap smearis invaluable to cervical cancer screening, but not infallible. In fact, PapSure greatly reduces “false negatives,” which someclinical studies show occur in as many as 55 percent of traditional Pap smears. This means that there is as high as a 55 percent chance that Pap smearresults that are actually positive for cervical cancer are reported as negative. There are a numberof reasons why a traditional Pap smear may appear normal even though abnormalcells exist on the cervix. Errors in detecting cervical abnormalities may occur due to barriers to exfoliation or “shedding”ofcells N iN sali . S Teal A new diagnostic tool is help- ing increase the accuracy of cervical cancer screenings. from the surface of the cervix, inadequate cell sample collection, omissions or mistakes in transferring cells to a slide and human error in evaluating cancerouscells that are collected. A PapSure exam, which combines a traditional Pap smear with a speculoscopy using Speculite more reliably, predicts the absence of disease than the Pap smear alone. Further, a positive speculoscopy alone does not necessarily indicate the presence of disease. Therefore, the key advantage to physicians and women is the confidence gained by combining the results of a traditional Pap smear with a speculoscopy. PapSure provides a greater level of confidence with cervical screenings by identifying more women with possible abnormalities. Women who have a PapSure exam may gain reassurance, because the visual results are available immediately. This information is important for women who may require further clinical evaluation or cancer treatment. Cervical cancer is almost 100 percent curable if detected early. About 55 million Pap smears are performed each year in the U.S. According to the National Cancer Institute (NCI), approximately 15,000 women are diagnosed with cervical cancer each year in the U.S. and about 5,000 of those womenwill die.
