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GEN News Highlights : Oct 28, 2010

FDA Sanctions Thermo Fisher Scientific’s MRSA Test for Use with Blood Samples

Original Spectra MRSA clearance in 2008 was for detection of nasal colonization.

Thermo Fisher Scientific received FDA clearance for additional claims for Spectra MRSA. The test is now available for the qualitative detection of MRSA from positive blood cultures demonstrating Gram-positive cocci on Gram stain.

Original approval was granted in 2008 and covered use of the product to detect nasal colonization of MRSA. Spectra MRSA is manufactured, distributed, and sold under the Thermo Fisher specialty brand Remel.

Spectra MRSA is a selective chromogenic medium that can be adopted in healthcare facilities to aid in appropriate patient management. It provides results within 24 hours, allowing more targeted antibiotic therapy.

“The need for more aggressive prevention measures to quickly identify and stop the spread of MRSA is critical to reduce healthcare-associated infections in clinical settings, and hospitals need cost-effective solutions for improving patient outcomes,” says Mary Jo Deal, vp and GM of Thermo Fisher Scientific, Microbiology Americas.

“Spectra MRSA is the first and only chromogenic media to offer results in 24 hours for both active surveillance of MRSA and detection of MRSA from positive blood cultures, resulting in a simple, economical solution that easily fits into routine laboratory testing procedures.”