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| |  Study Shows PapNet Can Improve Diagnosis Of Borderline Pap Smears SUFFERN, NY -- April 17, 1998 -- In the United States there are at least two million Pap smears annually that are diagnosed as atypical squamous cells of undetermined significance (ASCUS) and an estimated $3 to 4 billion US is spent annually on evaluation, triage and treatment of patients with ASCUS smears. A new study, published in this month’s issue of the journal Obstetrics & Gynecology, shows that computer-assisted review of ASCUS Pap smears with PapNet(R) testing revealed signs of more significant neoplasia in a significant number of ASCUS smears, and thus may provide a relatively cost-effective method for the future management of ASCUS patients. The study authors reviewed ASCUS smears from 160 women to evaluate the value of the PapNet computer-assisted test in identifying those cases that were most likely to contain signs of precancer or cancer that were not detected by microscopic screening. The study results support the use of the PapNet test as a cost-effective, accurate method of follow-up for the ASCUS smear. PapNet review of 160 ASCUS smears resulted in an upgrade in 20.6 percent (33/160) of cases to Squamous Intraepithelial Lesions, including low-grade and high-grade neoplasia. Of these, 79 percent (26) had biopsy-confirmed Cervical Intrapithelial Neoplasia or Human Papillomavirus infection. The seven Pap smears upgraded with the PapNet test but not shown to have an abnormal biopsy were examined by a second pathologist for adjudication who confirmed cytologic evidence of an SIL on all seven of these cases. "This technology is exciting because it is a safe and relatively cost-effective means of identifying patients with a cytologic diagnosis of ASCUS but who may ultimately harbour a more serious condition," said the study's lead author Raymond Kaufman, MD, professor of obstetrics and gynecology and pathology, Baylor College of Medicine, Houston, TX. The borderline ASCUS diagnosis usually results in patient anxiety and a management challenge for the clinician. Some women with ASCUS smears harbour a more serious lesion (precancerous or cancerous) while in many cases the ASCUS lesion will regress without follow-up. Given the uncertainty of the diagnosis, the follow-up performed by clinicians is unnecessarily costly in a significant number of cases. Current follow-up protocols for the ASCUS smear vary from repeating the Pap smear in three to six months to performing an immediate colposcopy. The issue of what constitutes appropriate management is considered controversial. Repeat Pap smears following an ASCUS smear have a high false-negative rate and colposcopy, while effective in the detection of cervical abnormality, ranges in price but can be expected to cost $350 or more. This study suggests that use of the PapNet test, at a cost of approximately $35, provides a follow-up avenue that can more accurately identify those women who require immediate colposcopy and biopsy. The PapNet system utilises neural network computer technology to identify and display potentially precancerous and cancerous cells among the tens of thousands of cells on cervical smears. These cells are captured as magnified images and projected on to a high-resolution video screen for diagnostic analysis by a cytology professional. In the United States, the PapNet system is currently approved and used as a supplemental test in the rescreening of Pap smears previously assessed as negative.
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