bioMérieux BacT/ALERT^® 3D Technology Acknowledged For Second Time As Essential Component in Platelet Collection System
Technological combination yields increaesed platelet product shelf life

DURHAM, N.C. (November 21, 2005) — bioMérieux, a world leader in the field of in vitro diagnostics for medical and industrial applications, today announced that its BacT/ALERT^® 3D Microbial Detection System will play yet another integral role in a leading Single Donor Platelet Technology system. Baxter Healthcare Corporation, recently received clearance by the U.S. Food and Drug Administration (FDA) for apheresis platelets to be collected with its AMICUS^® Separator and stored in Baxter’s PL 2410 collection container for routine storage and patient transfusion up to seven days. Clearance was obtained on the condition that the platelets are tested using the bioMérieux BacT/ALERT^® Microbial Detection System, as described in the AMICUS Separator Operator’s Manual for seven-day platelet protocol.

The FDA clearance will now allow blood banks that use the AMICUS Separator system to store single donor platelets for up to seven days. Until this year, platelets had to be transfused within five days of collection due to concerns about bacterial contamination. The short shelf life of platelets creates continuing challenges for blood suppliers to meet transfusion needs. The two-day extension of platelet shelf life will have a positive impact on United States platelet supply.

Earlier this year the BacT/ALERT received clearance with the GAMBRO-BCT Trima^® and COBE Spectra™ Collection Systems for routine storage and patient transfusion up to seven days. With Baxter’s clearance BioMérieux’s BacT/ALERT Microbial Detection System is the only system approved that allows blood centers to extend platelet shelf life from 5 to 7 days.
“Bacterial contamination of blood is a serious threat, and the blood community is very diligent about advancing testing of blood components for aerobic and anaerobic organisms,” said Eric Bouvier, president and CEO, bioMérieux, Inc. “BacT/ALERT is a proven system that is currently being used by most U.S. blood banks for testing microbial contamination and we're very proud of BacT/ALERT's role in such a significant advancement in platelet shelf life.”

BacT/ALERT 3D is a state-of-the-art, automated microbial detection system that integrates blood, sterile body fluid and mycobacteria culturing. In addition to its space-saving modular design, easy touch-screen operation and flexible data management options, BacT/ALERT 3D utilizes industry-exclusive plastic BacT/ALERT bottles. These unique plastic bottles are designed to help laboratories better adhere to the U.S. Department of Occupational Safety and Health Administration (OSHA) Blood Borne Pathogens Standard and other regulatory mandates. The BacT/ALERT bottles help protect laboratory and hospital staff from the risk of hazardous sharp exposure and accidental injury. Safety is a key factor in blood platelet collection, since over 70 percent of the annual 2.2 million-platelet transfusions in the U.S. are done through apheresis and incorporate contaminant testing.

About bioMérieux INDUSTRY

bioMérieux INDUSTRY provides product solutions to quality control and research microbiology laboratories. Applications served include environmental monitoring, sterility testing, pathogen screening, quality indicators, microbial identification, in-process quality control testing, microbial limits and preservative effectiveness testing.

About bioMérieux

A global leader in disease prevention and management, bioMérieux provides assays, reagents and instrumentation for clinical microbiology, coagulation, immunoassay, and nucleic acid diagnostics; and also for product quality control in the blood bank, agri-food, cosmetics and pharmaceutical industries. Based in Marcy-l'Etoile, France, the company's U.S. headquarters is in Durham, North Carolina.

With sales of 1 billion Euros in 2003, bioMérieux ranks as the eighth-largest biological diagnostics company worldwide. Over 81% of its activity takes place on an international level. Investment in research and development represents 13% of sales.

bioMérieux employs 5400 people throughout the world, including 3200 in Europe and 1500 in the U.S. The group has 15 production sites located in France, the United States, Brazil, Italy and the Netherlands, as well as a European logistics center in France. Already present in over 130 countries, with more than 110 distributors and 32 subsidiaries, bioMérieux continues its international development by strengthening its presence in Latin America and Asia.

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