FDA Clears Thermo Fisher For MRSA Test Medium

Armen Hareyan's picture
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Thermo Fisher Scientific has received FDA clearance for Spectra MRSA, a test designed to screen for methicillin-resistant Staphylococcus aureus (MRSA), more commonly known as the "superbug." With the highest Positive Predictive Value commercially available for MRSA screening, Spectra provides accurate results within 24 hours. The Spectra MRSA test is manufactured, distributed and sold under the Thermo Fisher specialty brand, Remel.

MRSA has become a major public health concern, with occurrences on the rise in healthcare facilities nationwide. According to a recent report by the Association for Professionals in Infection Control and Epidemiology (APIC), MRSA is prevalent in 46 of 1,000 patients in the U.S. -- 8 to 11 times higher than previous estimates. Moreover, their findings suggest that MRSA, which is antibiotic-resistant and difficult to treat, may lead to as many as 119,000 patient deaths in U.S. hospitals annually.

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In response to these findings, APIC issued a guide for the elimination of MRSA transmission in hospital settings. The guide includes comprehensive prevention measures, such as adherence to Centers for Disease Control and Prevention guidelines for hand hygiene, use of contact precautions and targeted screening cultures.

"The need for more aggressive prevention measures to stop the spread of MRSA means that healthcare facilities are looking for cost-effective ways to test more patients, around the clock," said Marijn E. Dekkers, president and chief executive officer of Thermo Fisher Scientific. "Spectra MRSA offers healthcare facilities a high-performance solution that integrates with routine laboratory workflows, enabling them to take a more proactive approach to patient care and safety."

Spectra MRSA is a ready-to-use, labor-saving test easily adopted in any healthcare facility to enable continuous testing of patients. The test medium is easy to read, with MRSA appearing as distinctive dark blue colonies. Its use can help to simplify MRSA screening programs, allowing patient testing 24 hours a day, 7 days a week.

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