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Title: Papnet Testing Helps Laboratories Detect Cervical Cancer Earlier
URL: http://www.pslgroup.com/dg/3ECB2.htm
Doctor's Guide
October 21, 1997


SUFFERN, NY. -- October 21, 1997 -- Researchers have determined that Papnet-assisted reviews of smears result in a more accurate screening process than the current practice -- leading to an earlier and more effective detection of pre-cancerous and cancerous cells in the cervix.

The study of Neuromedical Systems, Inc.'s Papnet test appears in this month's issue of Human Pathology.

The multi-center trial (nine university hospital centers and one commercial laboratory in the United States) reviewed a total of 10,153 smears divided into two groups. The index group was comprised of 487 Pap smears previously rated as negative or within normal limits from women who subsequently developed confirmed high-grade cervical neoplasia or invasive cancer. These 487 smears had previously been screened by routine manual microscopic procedures and were subject to all quality control measures mandated by the U.S. government.

The second or control group consisted of 9,666 which were reported as negative based on routine manual microscopic screening (in some cases multiple microscopic screening) and quality control. All 10,153 slides were prospectively analyzed by cytologists using Papnet-assisted computer screening. The investigators were blinded as to the origin or history of the slides.

The study found, with the assistance of Papnet computer-generated video images, the cytologists were able to detect evidence of abnormalities in Pap smears from 31.6 percent of women whose Pap test was previously thought to be negative or normal. Further, the researchers showed the abnormalities found would have been detected more than a year earlier using Papnet-assisted screening in 91.6 percent of these patients and more than two years earlier in more than a third (36.1 percent) of these women.

Unexpectedly, the study also revealed evidence of abnormality in 4.8 percent of the negative control smears (464/9,666). In addition, historical data from several contributing investigative sites documented Papnet-assisted rescreening can detect more than five times the number of pre-cancerous lesions compared with routine quality control rescreening of the same number of slides using a microscope alone.

"This is a landmark study. It shows that even in laboratories that strive to maintain a high level of accuracy, false negative cervical smears will occur," said the study's lead investigator Leopold Koss, MD, professor and chairman emeritus of the department of pathology at Montefiore Medical Center in New York. "The widespread implementation of this computer-assisted technology in laboratories will help address this issue and will increase our ability to detect cervical abnormality more efficiently and have a positive impact on patient care."

"The traditional Pap smear has contributed to the dramatic decrease in deaths from cervical cancer. Nevertheless, its accuracy has been limited to-date because of its dependence on the microscope and human manual screening," said Dr. Gary Goldberg, professor and director of gynecology, associate
director of gynecologic oncology, Albert Einstein College of Medicine and Montefiore Medical Center.

"This study demonstrated that this applied computer technology can assist the cytologist/cytopathologist in detecting a greater number of abnormal smears and, therefore, help the clinician prevent invasive cervical cancer."

More information on: Papnet, Neuromedical Systems, Inc.a>

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