NeoPath's patented automated Pap smear rescreening system gains important government approval; Decision allows AutoPap 300 QC System to replace federally mandated rescreening requirement, rendering previous quality control methods obsolete.SEATTLE--(BUSINESS WIRE)--March 13, 1996--A decision by the Health Care Financing Administration Health Care Financing Administration, n.pr department in the U.S. agency of Health and Human Services responsible for the oversight of the Medicaid and Medicare benefit programs, including guidelines, payment, and coverage policies. (HCFA HCFA abbr. Health Care Financing Administration HCFA, n.pr See Health Care Financing Administration. ) has cleared the way for improved accuracy in 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. screening. HCFA has granted its approval for clinical laboratories to use the AutoPap(R) 300 QC System from NeoPath(R) 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) ) for slide selection in the quality control review of Pap smear slides that have been initially screened by cytologists as normal. The system will help laboratories reduce the number of missed abnormal Pap smears ("false negatives"). The Clinical Laboratory Improvement Act of 1988 (CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a 88) requires that laboratories select 10 percent of Pap smears initially classified as normal and subject them to an additional manual review. With the HCFA ruling, laboratories can now improve their quality control procedures by using the AutoPap 300 QC System, which rescreens 100 percent of Pap smears initially classified as normal and selects for manual rescreening those Pap smears most likely to include false negatives. The HCFA decision was delivered in a March 1 letter from Judith A. Yost, director of the Center for Laboratories, Health Standards and Quality Bureau, the unit of HCFA responsible for interpreting CLIA regulations. In September 1995, the U.S. Food and Drug Administration granted NeoPath PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy approval to market the AutoPap 300 QC System. In clinical trials, the device demonstrated as much as a five-fold improvement in the detection of false negative Pap smear false negative Pap smear False negative smear Gynecology A Pap smear from a woman with a premalignant or malignant lesion that was classified incorrectly as containing no abnormal cells during routine Pap smears. See Cervical cancer. slides over a standard 10 percent random quality control procedure. By the same standard, the system showed up to an eight-fold improvement in the detection of biopsy-confirmed high grade and cancer slides. The AutoPap 300 QC System is presently the only fully automated system approved for quality control rescreening of Pap smears. It is a breakthrough medical device that uses proprietary image-processing computers, video imaging technology and comprehensive image interpretation software to analyze the thousands of microscopic images from a Pap smear slide. NeoPath Inc. developed the AutoPap 300 QC System in pursuit of its goal to help eradicate cervical cancer worldwide. The company's core expertise is in the research, development, and commercialization of technologies to automate the interpretation of medical images. The company, with headquarters in Redmond, Wash., has approximately 130 employees. CONTACT: NeoPath Inc., Redmond Volker Kettering or Donna DeLong, 206/869-7284 or EvansGroup Public Relations Steve Bryant, 206/270-4664 |
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