FDA Clearance for Rapid Detection of Antibiotic Resistant Gram Positives

Dade Behring Inc. has received clearance from the 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).
  

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 vancomycin[1-3]. 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 continue[1-3].

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).

References
[1]. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Research report: The Problem of Antimicrobial Resistance. April 2006. http://niaid.nih.gov/factsheets/antimicro.htm (accessed August, 23, 2007).
[2]. Consumers Union. Press release: Groundbreaking Report Shows Alarming MRSA Infection rates at U.S. Hospitals. http://www.consumersunion.org/pub/2007/06/004646print.html (accessed August 24, 2007).
[3]. Silver Colloids. Publication: Antibiotic Resistance a Growing Problem.
http://www.silver-colloids.com/Pubs/antibiotic-resistance.html (accessed August 24, 2007).