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BD Announces FDA 510(k) Clearance of Molecular Test for Legionella pneumophila
May 24, 2004

Contact: Barbara Kalavik
BD Diagnostics
(201) 847-4209
E-mail: Barbara_Kalavik @ bd.com

Sparks, MD USA -- Monday, May 24, 2004 -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the BD ProbeTec™ ET Legionella pneumophila DNA Amplified Assay.

Based on BD's proprietary real-time nucleic acid amplification technology, Strand Displacement Amplification (SDA), the Legionella assay is designed for the detection of L. pneumophila (serogroups 1-14) and performs amplification and real-time detection in a one-hour assay format. It is one of several assays under development at BD for the detection of organisms that cause atypical pneumonia. Other assays being submitted to the FDA for the detection of atypical pneumonia pathogens include Chlamydiaceae family and Mycoplasma pneumoniae.

According to Victor Yu, M.D., Professor of Medicine at the University of Pittsburgh and Chief, Infectious Disease Section, VA Pittsburgh Healthcare System and a leading international expert on Legionnaire's Disease, the availability of this assay is a "major advance in diagnostics for this disease. Legionnaire's disease is one of the top three or four causes of community-acquired pneumonia in the U.S. and also represents one of the most deadly causes of pneumonia. Patients need to be on correct therapy from day one and the commercial availability of a rapid, molecular amplification assay to detect L. pneumophila should allow this to happen. In addition, it provides an improvement over current diagnostic assays, since culture takes at least three days and the urinary antigen test for L. pneumophila (serogroup 1) may miss up to 12-20% of L. pneumophila. Overall, the assay could potentially reduce the mortality associated with this disease and decrease antimicrobial resistance, since it would be possible earlier in the disease course to use directed therapy against this organism once it's detected."

"Most currently available diagnostic tests for atypical pneumonia pathogens do not provide real-time information, which reduces their impact in patient care," said Michael Towns, M.D., VP Medical Affairs, BD Diagnostics. "Rapid results from molecular methods can be actively considered in patient management and have the potential to provide related benefits like reduced healthcare costs from shorter length of stay and less costly therapy selections."

"The FDA clearance of the Legionella assay is a significant milestone for BD and is consistent with our molecular development strategy," said Michael Little, Ph.D., Worldwide Director of Molecular Diagnostics at BD. "One of our approaches in molecular diagnostics is to pursue assays that offer high clinical value for the unmet needs of physicians in the management of their patients. This includes emerging diagnostic areas where future growth is attractive as molecular methods are adopted into patient management algorithms."

About Pneumonia An estimated nine million cases of pneumonia occur worldwide every year, leading to one in five hospitalizations in the U.S. Today, less than half of the cases of pneumonia worldwide have a causative agent identified using current technologies. L. pneumophila, Chlamydia and M. pneumoniae are all also part of the differential diagnosis for suspected cases of SARS. The SARS epidemic that occurred during 2003 was a significant cause of mortality in the patients that were primarily infected in China, Hong Kong and Canada.

About BD ProbeTec ET Assays for the BD ProbeTec ET System feature homogeneous amplification and real-time detection technology, combining the power of BD proprietary strand displacement amplification (SDA), with an energy transfer (ET) detection method. SDA is a patented isothermal amplification technology capable of generating billions of copies of target molecules from a single DNA or RNA template in just minutes.

The BD ProbeTec ET System, first marketed in 1998, is the only commercially available real-time DNA amplification assay for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. The short time to results, minimal labor, high-throughput and ease-of-use have combined to make the BD ProbeTec ET System the choice for laboratories throughout the world.

BD is a medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry, and the general public. BD manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products. For the fiscal year ended September 20, 2003, BD reported total revenues of $4.528 billion.




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