ajulius,
Here is the latest news release on Papnet:
Newly Published Study Demonstrates that PAPNET(R) Testing Can Help Laboratories Detect Cervical Cancer More Efficiently and Earlier
October 21, 1997 08:31 AM
SUFFERN, N.Y., Oct. 21 /PRNewswire/ -- Neuromedical Systems, Inc. (NSI) NSIX announced today the publication of the results of a multicenter clinical trial demonstrating the effectiveness of the PAPNET test in improving timely reading and interpretation of Pap smears. The study appears in the October issue of the peer-reviewed medical journal Human Pathology, and was part of the submission leading to the U.S. Food and Drug Administration approval of the computerized test. In their evaluation, the researchers determined that PAPNET-assisted review of smears results in a more accurate screening process than current practice, leading to an earlier and more effective detection of precancer and cancer of the cervix.
This US multicenter trial (nine university hospital centers and one commercial laboratory) 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 was designed to minimize bias either in favor of, or against, the PAPNET technology, and to reflect the actual clinical use of the PAPNET system.
The study found that with the assistance of PAPNET computer-generated video images, the cytologists were able to detect evidence of abnormalities in Pap smears from 31.6% of women whose Pap test was previously thought to be "negative" or "normal." Further, the researchers showed that the abnormalities found would have been detected more than a year earlier using PAPNET-assisted screening in 91.6% of these patients, and more than two years earlier in more than a third (36.1%) of these women.
Unexpectedly, the study also revealed evidence of abnormality in 4.8% of the "negative" control smears (464/9,666). In addition, historical data from several contributing investigative sites documented that PAPNET-assisted rescreening can detect more than five times the number of precancerous 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. 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," said the study's lead investigator Leopold G. Koss, MD, Professor and Chairman Emeritus, Department of Pathology, Montefiore, Medical Center in New York.
"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 L. Goldberg, Professor and Director of Gynecology, Associate Director of Gynecologic Oncology, Albert Einstein College, of Medicine and Montefiore Medical Center, which was one of the ten study sites. "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."
PAPNET testing is available through a network of laboratories nationwide. Laboratories, clinicians and patients interested in learning more about PAPNET testing or Neuromedical Systems, Inc., may call toll-free at 1-800-PAPNET4 or visit NSI on the World Wide Web at nsix.com .
Neuromedical Systems, Inc. is a healthcare technology company focused on diagnostic screening applications to aid in the early detection of certain cancers. Neuromedical's first product, the PAPNET Testing System, increases the accuracy of cervical screening by displaying potentially abnormal cells for review and analysis by a cytology professional. The Company believes that increasing access to routine screening and the adoption of PAPNET testing can reduce the morbidity and mortality associated with cervical cancer.
Safe Harbor Statement
Except for the historical information contained herein, the matters discussed in this press release may include forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934 which reflect the Company's current views with respect to further events and financial performance. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from historical results or those anticipated. For information regarding these risks and uncertainties, see the Cautionary Statements set forth in the Company's Securities and Exchange Commission filings, including its Annual Report on Form 10-K for the year ended 1996. The words "believe", "expect", "anticipate", and similar expressions identify forward-looking statements, which speak only as of their dates. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. SOURCE Neuromedical Systems, Inc. |
