DURHAM, N.C., April 1 /PRNewswire/ -- bioMerieux, a world leader in the field of in vitro diagnostics for medical and industrial applications, today announced that its BacT/ALERT(R) 3D Microbial Detection System will play an integral role in a leading Single Donor Platelet Technology system. Gambro BCT, Inc., recently received clearance by the U.S. Food and Drug Administration (FDA) for apheresis platelets to be collected with its Trima(R) and COBE Spectra(TM) Collection Systems for routine storage and patient transfusion up to seven days. Clearance was obtained on the condition that the platelets are tested with the bioMerieux BacT/ALERT Microbial Detection System, and used as described in the Gambro BCT seven-day platelet protocol.
The FDA clearance will now allow blood banks that use the Gambro BCT system to store single donor platelets for up to seven days. Previously, 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.
"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, bioMerieux, 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.
bioMerieux, Inc. is the U.S. subsidiary of bioMerieux S.A., a company headquartered in France. bioMerieux is a leading international diagnostics group that specializes in the field of in vitro diagnostics for clinical and industrial applications. bioMerieux designs, develops, manufactures and markets systems (i.e. reagents, instruments and software) used in:
Clinical applications: the diagnosis of infectious diseases such as hepatitis, HIV, tuberculosis and respiratory illnesses, as well as pathologies such as cardiovascular diseases and cancer, based on the analysis of biological samples (such as blood, saliva or urine); and
Industrial applications: the microbiological analysis of food, environments (such as water and air), surfaces and pharmaceutical and cosmetic products, based on the analysis of product or environmental samples. bioMerieux has pioneered this business and is the world leader.
In 2004, the company's sales reached 931 million euros (i.e., more than one billion dollars) and eighty-two percent of the company's sales are international. The company is present in more than 130 countries through 33 subsidiaries and a large network of distributors, which positions the company well to benefit from the growth potential of the in vitro diagnostics market. Some important drivers that underpin this growth are aging populations and age-related illness, illnesses related to life-style and eating habits, emerging pathogens, the development of antibiotic-resistant bacteria, the fight against bio-terrorism, the recognition of the importance of the quality of food products, cosmetics and pharmaceuticals. The company employs more than 5,300 people worldwide.
bioMerieux is listed on the Premier Marche of Euronext, Paris (FR0010096479 - BIM). For more information, visit the web site at http://www.biomerieux-usa.com/ .