Test for VRE Colonization Approved by FDA

Thermo Fisher Scientific Inc. announces today that it has received Food and Drug Administration (FDA) clearance for Spectra VRE, a test designed to screen for vancomycin-resistant Enterococcus (VRE).

Thermo Fisher Scientific Inc. announces today that it has received Food and Drug Administration (FDA) clearance for Spectra VRE, a test designed to screen for vancomycin-resistant Enterococcus (VRE). Spectra VRE is the first chromogenic media for the 24-hour detection of VRE colonization with rectal swabs and stool specimens. Spectra VRE is manufactured, distributed, and sold by Remel, a product brand of Thermo Fisher Scientific.

Vancomycin-resistant enterococci (VRE) are the third leading cause of healthcare associated infections resulting in higher morbidity, mortality, and hospital costs.1-2 VRE colonization can progress to infection, especially for people with certain risk factors.3 Proactive VRE screening is an important part of an infection control and prevention program to reduce the spread within the hospital. The potential exists for VRE to transfer genetic vancomycin resistance to other Gram-positive organisms, especially methicillin-resistant Staphylococcus aureus, creating vancomycin-resistant S. aureus (VRSA). To date, 11 cases of VRSA have been reported in the U.S., and it remains a serious public health concern due to limited treatment options.4

"Early detection of patients colonized with VRE is critical for the identification and isolation of patients colonized with multidrug-resistant organisms to minimize transmission in the healthcare setting. Detection and isolation of patients colonized with VRE can help clinicians provide appropriate patient management and maintain a healthier healing environment," says Mary Jo Deal, vice president and general manager of Microbiology Americas for Thermo Fisher Scientific. "Thermo Fisher Scientific has developed Spectra VRE to offer healthcare institutions a high performing, economical solution that easily integrates into routine microbiology laboratory workflows, enabling our customers to take a more proactive approach to patient care and safety."

Spectra VRE is a ready-to-use test medium that can differentiate between vancomycin-resistant E. faecalis and E. faecium from stool and rectal swab specimens within 24 hours with no confirmatory testing required.

References:

1. Hidron, A.L. et. al. Infection Control and Hospital Epidemiology. 2008;29:996-1011.2. Carmeli, Y. et. al. Archives of Internal Medicine. Volume 162; October 28, 2002.3. Zirakzadeh, M.D. et. al. Mayo Clinic Proceedings. 2006; 81(4):529-536.4. http://www.cdc.gov/ncidod/dhqp/ar_vrsa_labUpdate.html#