FDA Green-Lights Thermo Fisher Scientific’s VRE Diagnostic
Spectra VRE detects colonization in 24 hours.
Thermo Fisher Scientific received FDA sanction for Spectra™ VRE, a test to screen for vancomycin-resistant Enterococcus (VRE). Spectra VRE is manufactured, distributed, and sold by Remel, a product brand of Thermo Fisher Scientific.
Spectra VRE is reportedly the first chromogenic media for the 24-hour detection of VRE colonization with rectal swabs and stool specimens. It can differentiate between vancomycin-resistant E. faecalis and E. faecium within 24 hours with no confirmatory testing required, according to Thermo Fisher Scientific.
"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,” notes Mary Jo Deal, vp and GM, microbiology Americas, Thermo Fisher Scientific. “Detection and isolation of patients colonized with VRE can help clinicians provide appropriate patient management and maintain a healthier healing environment. 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.”
Vancomycin-resistant enterococci are the third leading cause of healthcare-associated infections, according to the firm. VRE colonization can progress to infection, especially for people with certain risk factors. Additionally, there is the potential 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, eleven cases of VRSA have been reported in the U.S., Thermo Fisher Scientific reports.