News & Events

San Diego, CA (May 21, 2007) --

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced today that it obtained European CE Mark approval for the BD GeneOhm^TM StaphSR assay. BD is awaiting U.S. Food and Drug Administration 510(k) clearance for the assay to be made available in the United States.

This test is the first assay for the rapid and simultaneous identification of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) from patients with positive blood cultures, such as those performed using the BD BACTEC™ blood culture system. This assay will enable physicians to implement the right treatment earlier for patients with bloodstream infections, transforming patient care and significantly reducing healthcare costs.

“The CE marking for the BD GeneOhm StaphSR assay is another reflection of BD’s commitment to providing our customers with a complete menu of molecular diagnostics to rapidly identify, prevent, and control infections and transmission of healthcare-associated infections,” commented Vincent Forlenza, Executive Vice President, BD. “This new test complements our highly sensitive BD GeneOhm MRSA assay, which rapidly identifies patients who are colonized with MRSA and allows infection control professionals to break the chain of MRSA transmission and infection earlier.”

“The BD GeneOhm StaphSR assay provides a rapid, definitive identification of SA and MRSA from blood cultures. This allows for more appropriate isolation procedures and agent-specific antimicrobial therapy, resulting in reduced patient morbidity and mortality as well as an overall reduction in healthcare costs,” said Thomas Davis, M.D., Ph.D., Director of Clinical Microbiology, Wishard Memorial Hospital, Indianapolis, Indiana.

The BD GeneOhm StaphSR assay is a fast, simple assay that is performed directly from positive blood cultures. This new assay is also designed to promote sooner appropriate antibiotic selection, thereby helping to avoid unnecessary use of vancomycin. The emergence of vancomycin-resistant Staphylococcus aureus (VRSA) is a growing concern worldwide.

The BD GeneOhm StaphSR assay requires less technologist time and provides results within two hours, compared with over two days for traditional microbiology cultures. Studies have shown that providing physicians with important microbiology information earlier results in decreased mortality, length of stay and variable costs.

BD plans to make additional submissions to the FDA for wound and nasal swab claims with the BD GeneOhm StaphSR assay, with an important application being the identification of surgical patients at risk of a life-threatening surgical site infection. BD is also developing rapid tests for the detection of the vanA and vanB genes associated with vancomycin-resistant enterococci (VRE), as well as a rapid assay for the identification of toxin genes associated with Clostridium difficile. Both of these organisms are of particular concern to healthcare providers worldwide because they are a major source of morbidity and mortality.

About BD

BD, a leading global medical technology company that manufactures and sells medical devices, instrument systems and reagents, is dedicated to improving people’s health throughout the world. BD is focused on improving drug therapy, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. The Company’s capabilities are instrumental in combating many of the world’s most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 27,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. For more information, please visit www.bd.com.