Dade Behring Receives FDA Clearance: Improved Formulation for Vancomycin on MicroScan Dried Gram-Positive Overnight Antimicrobial Susceptibility Test Panels.

DEERFIELD, Ill. -- Detects emerging resistant bacteria so clinicians can choose the best therapy for their patients

Dade Behring Holdings, Inc. (NASDAQ:DADE), the world's largest company solely dedicated to clinical diagnostics and a global leader in automated identification and antimicrobial susceptibility testing, today announced clearance from the U.S. Food and Drug Administration (FDA) for its improved formulation for the antimicrobial agent vancomycin on MicroScan(R) Dried Gram-Positive Overnight antimicrobial susceptibility test panels. Dade Behring is the only company offering an automated ID/AST system FDA cleared for improved detection of vancomycin-resistant Staphylococcus aureus (VRSA).

"Antimicrobial resistance is a global health care issue that Dade Behring is addressing and taking very seriously," said Jim Reid-Anderson, Chairman, President and CEO, Dade Behring. "According to the Centers for Disease Control and Prevention (CDC), the decreased susceptibility of vancomycin-resistant S. aureus strains leave clinicians with few therapeutic options for treating bacterial infections. Dade Behring has taken a leadership role in the area of detecting emerging S. aureus resistance to vancomycin, and we dedicate a large portion of our research to finding improved MicroScan tests to detect antimicrobial resistance."

"S. aureus strains have developed resistance to many of the commonly used antimicrobial agents," said Barbara Zimmer Ph.D., Director of Clinical and Scientific Affairs, Dade Behring, MicroScan. "Our research team knows how critical this issue is to clinicians and their patients; we understand that vancomycin continues to be a critical antimicrobial agent for treating infections caused by S. aureus strains, that are resistant to the penicillins and other antimicrobial agents. That is why we have taken a leadership role and have been so committed to providing our customers with this improved formulation for vancomycin to detect VRSA on our panels."

As stated in the CDC's Morbidity and Mortality Weekly Report (MMWR(TM)), strategies to improve adherence to current guidelines to prevent transmission of antimicrobial resistant micro-organisms in health-care settings should be a priority for all health-care facilities in the United States. It was also stated that S. aureus should be tested for resistance to vancomycin using a MIC method(1). All MicroScan testing panels, including the FDA-cleared vancomycin formulation, are based on this true MIC (minimal inhibitory concentration) method, which is considered to be the most sensitive method to determine susceptibility to antimicrobial agents.

S. aureus is a commonly isolated bacterium known to cause a variety of infections from skin infections to sepsis. Clinicians must determine the antimicrobial susceptibility since infections can often spread quickly in a hospital environment. Clinical isolates of S. aureus, with reduced susceptibility to vancomycin were first reported in the late 1990's. To date, four strains of vancomycin-resistant S. aureus have been reported. Dade Behring has taken a continuous leadership role in detecting these strains due to the accuracy of the MicroScan(R) automated ID/AST system.

Dade Behring has nearly 60 MicroScan panels of tests, with up-to-date antibiotics including overnight, rapid and specialty panels. Dade Behring is now in the process of incorporating the new formulation of vancomycin into the entire product line of MicroScan(R) Dried Gram-Positive Overnight panels sold globally. It is anticipated to be available in all of the existing configurations by fall 2005.

About Dade Behring

With 2004 revenues of nearly $1.6 billion, Dade Behring is the world's largest company dedicated solely to clinical diagnostics. It offers a wide range of products, systems and services designed to meet the day-to-day needs of labs, delivering innovative solutions to customers and enhancing the quality of life for patients. Additional company information is available on the internet at www.dadebehring.com.

(1) Centers for Disease Control and Prevention (CDC). Morbidity and Mortality Weekly Report (MMWR(TM)). July 5, 2002 / 51(26);565-567.