Automated Pap smear testing technology: what to expect; two products use different approach, technology to improve accuracy.SEATTLE--(BUSINESS WIRE)--Sept. 7, 1995--U.S. Food and Drug Administration Advisory Panel decisions earlier last month cleared the way for a significant improvement in the accuracy of screening Pap smear Pap smear or Papanicolaou smear Sample of cells from the vagina and cervix of the uterus for laboratory staining and examination to detect genital herpes and early-stage cancer, especially of the cervix. Developed by the Greek-born U.S. slides. The two products under consideration take dramatically different approaches to double-checking Pap smear slides for missed abnormalities. These slides hold as many as 300,000 cervical cells, a few of which might signal the early stages of preventable cervical cancer Cervical Cancer Definition Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors. . Which system is adopted by laboratories will have significant implications for the extent of accuracy gains and the overall cost of testing. On Aug. 7 and 8, the Hematology and Pathology Devices Advisory Panel unanimously recommended that the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approve two new automated systems for improving the accuracy of Pap smear screening. Recommended for approval were the AutoPap(R) 300 QC System from NeoPath Inc., Redmond, Wash., and the PAPNET Testing System from Neuromedical Systems Inc. (NSI See Network Solutions. NSI - Network Solutions, Inc. ), Suffern, N.Y. At the hearing, PAPNET was shown to have a 30 percent improvement in "relative sensitivity," whereas the AutoPap System was shown to have a 400 percent improvement in "relative sensitivity," representing up to a five-fold improvement in detection of false negatives over the current random QC method. The AutoPap System also would cost customers considerably less. PAPNET could add as much as $1 billion to America's annual health care bill. That's if all of the 50 million Pap smears performed annually were subject to double-checking by PAPNET, for which consumers would pay an additional $20 per test. The AutoPap System would cost less than 25 percent of that figure. Implications for laboratory practice are profound. Labs in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. currently are required to select at least 10 percent of negative slides for rescreening. Most labs select these slides randomly. The AutoPap QC System has been recommended for approval to replace the random selection portion of current quality control procedures. When the system has been installed in the laboratory, it reviews negative slides and produces an enriched 10 percent sample so that cytotechnologists can double check those selected by the system as most likely to contain a missed abnormality. PAPNET, on the other hand, received a recommendation for approval only as an adjunctive test (following the laboratory's routine quality control procedures). The panel specifically disallowed the use of the PAPNET system to replace current quality control procedures. Therefore labs adopting this system would still be required to perform their own initial review and quality control testing, then send selected slides to an NSI facility to be analyzed. Days later, NSI would return the slides along with a data tape containing 128 electronic images for each slide. Cytotechnologists are required to review all images from each slide. Any suspect slides would then require manual microscopic review in their entirety. Data presented by NSI at the panel hearing showed that approximately 20-30 percent of the slides would have to undergo this manual review. All of these factors account for the significant difference in overall cost and turnaround time (1) In batch processing, the time it takes to receive finished reports after submission of documents or files for processing. In an online environment, turnaround time is the same as response time. between the two approaches. Neither product is yet available for sale, but in most cases the FDA follows the recommendations of the advisory panel. NeoPath Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :NPTH NPTH Non-Plated Through-Hole (PCB (printed circuit board manufacturing) ) developed the AutoPap 300 QC System in pursuit of its goal to help eradicate cervical cancer worldwide. The company's core expertise is the research, development and commercialization of technologies to automate the interpretation of medical images. The company, with headquarters in Redmond, employs approximately 110 employees. -0- NOTE TO EDITORS: Appearing before the FDA advisory panel meeting, some of the nation's foremost authorities on Pap smear screening lent their support to the FDA's clearance of the AutoPap 300 QC System. Several of these physician-scientists have agreed to make themselves available to discuss the subject of automated Pap smear testing. All have personally used and evaluated the instrument. Dr. David Wilbur Director, CytoPathology Department of Pathology and Laboratory Medicine University of Rochester The University of Rochester (UR) is a private, coeducational and nonsectarian research university located in Rochester, New York. The university is one of 62 elected members of the Association of American Universities. 716/275-5656 Dr. Thomas Bonfiglio Professor and Chairman Department of Pathology and Laboratory Medicine University of Rochester 716/275-3184 The University of Rochester is a leading academic institution for the study of cytopathology, including cervical cancer screening. Dr. Terry Colgan Head of Surgical Pathology surgical pathology n. A field in anatomical pathology concerned with examination of surgical specimens of tissues removed from living patients for the purpose of diagnosis of disease and guidance in the care of patients. , The Toronto Hospital Supervising Consultant, MDS MDS, n See temporomandibular pain-dysfunction syndrome. MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there Laboratories 416/340-4697 MDS is Canada's largest medical testing laboratory. CONTACT: NeoPath Inc. Patricia Milbank, Esq. VP, Regulatory Affairs and Quality Assurance 206/869-7284 or Donna DeLong, Director, Marketing, 206/869-7284 or John Stachowiak, CFO/VP, 206/869-7284 or EvansGroup Public Relations public relations, activities and policies used to create public interest in a person, idea, product, institution, or business establishment. By its nature, public relations is devoted to serving particular interests by presenting them to the public in the most Steve Bryant, Media Relations Consultant, 206/270-4664 or Fi.Comm Michael Newman, Investor Relations Investor relations The process by which the corporation communicates with its investors. Consultant 206/467-6732 |
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