FDA News

Dade Behring Receives FDA Clearance for Rapid-Result Gram Positive Microbiology Test

(Oct 08, 2007)-- Dade Behring has received clearance from the U.S. Food and Drug Administration (FDA) for use of its MicroScan Synergies plus Gram-positive panels. The new technology used in the panels allows for rapid two-hour identification of bacteria and same-day test results for detecting certain antibiotic-resistant bacteria that cause serious health threats in a hospital environment. Some of the antibiotic-resistant bacteria that may be identified on the same-day tested are:

* Methicillin-resistant Staphylococcus aureus (MRSA),
* Vancomycin-resistant Staphylococcus aureus (VRSA), and
* Vancomycin-resistant Enterococcus (VRE).

According to the Centers for Disease Control and Prevention (CDC), antibiotic resistance is one of the world’s most pressing public health issues. Antibiotic resistance prolongs illness in patients and puts them at a greater risk of death. It also increases the cost of health care resulting from more hospital admissions, longer hospital stays and the use of expensive antibiotics.

"Dade Behring feels strongly about addressing this global health issue and continues to develop automated microbiology tests that identify the latest antibiotic-resistant bacteria,” said Jim Reid-Anderson, Chairman, President and CEO, Dade Behring. "By more quickly confirming the diagnosis of an antibiotic-resistant infection, physicians can treat patients and mitigate life-threatening infections from spreading to others in the hospital environment.”

With the addition of Synergies plus Gram-positive panels, the Company now offers automated solutions for rapid identification and same-day detection of antibiotic-resistant bacteria, both for Gram-positive and Gram-negative bacteria. This is especially important as more strains of bacteria become resistant to antibiotics. For example, in 1971, the Centers for Disease Control and Prevention (CDC) reported only two percent of staphylococcus infections as resistant to the antibiotic methicillin. This number increased to 22 percent in 1995 and nearly 63 percent in 2004, resulting in an increase in the use of the antibiotic vancomycin1-3. The growing dependency on vancomycin led to the emergence of vancomycin-resistant S. aureus and enterococcus infections, posing a threat to health care environments and demonstrating a global trend that is expected to continue1-3.

The introduction of these new MicroScan panels secures Dade Behring's leadership position in automated identification and antimicrobial susceptibility testing, which is complemented by a worldwide reputation for quality and accuracy in the detection of emerging antibiotic-resistant strains of bacteria. Dade Behring has nearly 60 MicroScan panels of tests, with up-to-date antibiotics including overnight, rapid and specialty products. The Company was the first to offer an automated identification and susceptibility testing system cleared for improved detection of the emerging resistant bacterium vancomycin-resistant Staphylococcus aureus (VRSA).

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