AccuMed successfully completes TracCell clinical trials; Files results with FDA.CHICAGO--(HealthWire)--Nov. 21, 1996--AccuMed International Inc. (Nasdaq:ACMI) announced today that it has completed, ahead of schedule, clinical trials of its TracCell(TM) 2000 System, a fully automated slide mapping system to support Pap test Pap test, Pap smear, or Papanicolaou test (păp'ənē`kəlou), medical procedure used to detect cancer of the uterine cervix. primary screening. The results show the safety and efficacy of the TracCell System. In these trials, the TracCell never failed to present for review any diagnostic cells that were identified by cytotechnologists as needing interpretation by a pathologist. The TracCell 2000 is a clinical laboratory diagnostic tool which is used in the primary screening process to map 100% of all sides and present all diagnostically relevant material to cytologists for their interpretation and diagnosis. Although this 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. submission needs to deal only with the safety and efficacy of the TracCell, ongoing studies are being completed to demonstrate improvements in productivity, quality and the reduced cost compared to alternative approaches, including the use of monolayer mon·o·lay·er n. 1. A film or layer one molecule thick formed at the interface between water and either oil or air by a substance such as a partially esterified fatty acid that contains both hydrophobic and hydrophilic groups in the same preparations. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. Dr. Norman Pressman, president of AccuMed's Cytopathology division, the results of the clinical trials and studies that are being completed "have significant quality, productivity and cost reduction implications for the clinical laboratory and the future of 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. The availability of the AccuMed TracCell 2000 to the clinical laboratory market will help stem the rising tide Noun 1. rising tide - the occurrence of incoming water (between a low tide and the following high tide); "a tide in the affairs of men which, taken at the flood, leads on to fortune" -Shakespeare flood tide, flood of justifiable public and health care professional concerns surrounding a push toward complete automation of the Pap screening process and, most recently, questions regarding the benefits of utilizing monolayer specimens that add cost to the Pap test." "There is a great deal of confusion in the marketplace. After 40 years of performing Pap smear screening utilizing the same manual procedure, laboratories are being inundated in·un·date tr.v. in·un·dat·ed, in·un·dat·ing, in·un·dates 1. To cover with water, especially floodwaters. 2. with new automated products that suggest improved accuracy while, at the same time, adding significant costs to the Pap screening process. At this point, the general public is being frightened and confused into believing that automation, or a complete revamping of the screening and diagnostic process, is necessary to reduce the currently unacceptable false negative rates. We at AccuMed believe the solution to reduce the error rates in cervical cytology cytology (sītŏl`əjē), in biology, the study of the structure of all normal and abnormal components of cells and the changes, movements, and transformations of such components. screening lies in providing the trained professional cytotechnologists and pathologists with tools that enhance their ability to identify abnormalities that potentially could lead to serious medical consequences for the patient. These evaluations and studies clearly show that the TracCell/AcCell(TM) System will achieve these goals." Pressman added, "In this era of cost-containment, laboratories must look for ways to cut costs. However, cost containment cost containment, n the features of a dental benefits program or of the administration of the program designed to reduce or eliminate certain charges to the plan. should not come at the expense of the patient." Peter Gombrich, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , AccuMed International, said, "The completion of the clinical trial submission for the TracCell 2000 represents a significant leap forward for the Cytopathology division of AccuMed. The TracCell, in conjunction with AcCell, positions AccuMed to tap the $2 billion Pap smear screening clinical laboratory worldwide market." AccuMed International Inc., headquartered in Chicago, is a global laboratory diagnostic company. It is an emerging leader in the field of automated cytopathology (the screening of cell specimens), marketed under the AcCell System tradename. The company's Microbiology division manufactures and markets proprietary, FDA-approved bacteria disposable tests and instruments systems. Laboratories, clinicians and patients interested in learning more about the AcCell System may call AccuMed, toll free, at 800/650-2228. TracCell(TM) and AcCell(TM) are trademarks of AccuMed International. CONTACT: AccuMed International, Chicago Liz Gamble/Corporate Communications Dr. Norman Pressman/President, Cytopathology Division 312/642-9200 |
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