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BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS FILES 510(K) FOR FDA CLEARANCE OF FACSCOUNT, A COMPLETE SYSTEM FOR MONITORING PATIENTS WITH HIV INFECTION; NEW PRODUCT PROVIDES PRECISION, ACCESSIBILITY AND EASE-OF-USE IN MONITORING THE PROGRESSION OF THE HIV INFECTION

 SAN JOSE, Calif., Dec. 10 /PRNewswire/ -- Becton Dickinson Immunocytometry Systems (BDIS) announced that it has filed a 510(k) notification on July 19, 1993, with the United States Food and Drug Administration (FDA) for clearance of its FACSCount(TM) system for sale in the United States. BDIS' FACSCount system, used in monitoring patients with HIV, has been available on the international market since April 1993. BDIS is a long-time leader in the cell analysis market, and its FACSCount system is the first of its kind dedicated to obtaining absolute counts of CD4, CD8 and CD3 T lymphocytes.
 The FACSCount system offers an easy three-step method to improve the precision and accessibility of CD4 testing. The system is self- contained, eliminating the need for additional instrumentation and simplifying the sample preparation process. The FACSCount system uses whole blood, eliminating the need to lyse red cells in blood samples. Because samples require minimal preparation and handling, the chance of operator error decreases. Once a blood sample is analyzed using BDIS' FACSCount system, a summary printout of the absolute numbers of CD4, CD8 and CD3 T lymphocytes and a helper/suppresser ratio, as well as the control results, is printed from the built-in printer.
 "Cost effectiveness and ease-of-use of the FACSCount system will make accurate, reproducible testing for CD4, CD8 and CD3 counts more convenient and readily accessible to patients, including those in lesser- developed countries, afflicted with the HIV virus," said Kate Mulligan, BDIS marketing manager, Worldwide AIDS Program. "Because smaller laboratories, hospitals and physician groups will now be able to afford and use an accurate cell counting system, patients will receive the benefit of having local clinics monitor their immune cell levels," said Mulligan.
 Tracking levels of the CD4 T lymphocyte is important in monitoring the progression of AIDS. As the human immunodeficiency virus destroys the body's immune system, the number of CD4 cells drops. As a result, CD4 cells must be monitored regularly in patients with HIV. Because treatments and therapies are prescribed according to a patient's absolute number of CD4 T lymphocytes, an accurate, consistent method for monitoring the number of these cells is crucial.
 The Company
 In 1973, Becton Dickinson created the very first cell sorter, FACS(R). This sorter is now on display at the Smithsonian Institute in Washington, D.C. Today, BDIS manufactures a comprehensive and powerful product line of cell analysis systems available to research and clinical investigators, including highly sophisticated flow cytometers, computer software and monoclonal antibody reagents that analyze, isolate and characterize immune cells from blood and tissue.
 Headquartered in San Jose, Becton Dickinson Immunocytometry Systems is a division of Becton Dickinson and Co. (NYSE: BDX).
 NOTE: FACSCount is a trademark of Becton Dickinson and Co. FACS is a registered trademark of Becton Dickinson and Co.
 -0- 12/10/93
 /CONTACT: Kate Mulligan of BDIS, 408-954-2169; or Doug Free of The Stephenz Group, 408-286-9899, for BDIS/
 (BDX)


CO: Becton Dickinson Immunocytometry Systems ST: California IN: MTC SU: PDT

RB-LW -- SJ003 -- 2709 12/10/93 14:29 EST
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Date:Dec 10, 1993
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