FDA Clears Cepheid’s Next-Generation Test for MRSA Colonization

Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for Xpert MRSA NxG, the next generation methicillin-resistant Staphylococcus aureus (MRSA) infection control test from the leader in healthcare-associated infection (HAI) testing. Xpert MRSA NxG is an accurate, on-demand, molecular test that delivers actionable results in about an hour.
 
MRSA has been an infection prevention challenge for over a decade, during which, new strains have emerged, often escaping detection by conventional assays and threatening the substantial gains made in HAI prevention in recent years¹. To meet this challenge, Xpert MRSA NxG was developed utilizing an extensive library of MRSA strains collected from around the world and demonstrates unprecedented strain coverage. Integral to the new test design are updated PCR primers and probes that detect both mecA and mecC strains, which reduces the frequency of false-positive results due to “empty cassette” strains. The test has been validated for use with both ESwab (Copan) and rayon swabs.²
 
“MRSA surveillance remains a critical infection prevention activity for healthcare facilities and one that is challenged by the continued evolution of target sequences within MRSA,” said Dr. Fred C. Tenover, Cepheid’s Vice President for Scientific Affairs. “Fortunately, our global MRSA surveillance initiative has helped us keep ahead of the curve by alerting us to the emergence of novel strain types, enabling us to design a more comprehensive assay that takes into account major shifts, like the emergence of mecC, as well as more subtle changes in the SCCmec targets.”
 
Active surveillance testing using rapid molecular diagnostics, along with standard infection prevention practices, have been shown to reduce the spread of MRSA in healthcare settings³. Studies have shown that MRSA screening programs using on-demand molecular tests contribute to:
 

• Decreased MRSA infection rates in the ICU by 62%³
• Reduced isolation days by 44%⁴
• Decreased overall hospital costs⁴

 
Cepheid is committed to the fight against the spread of multidrug-resistant organisms. For information on the Diagnostics First education campaign, visit www.DiagnosticsFirst.com. Xpert MRSA NxG will begin shipping in December.
 
References
¹Bal et al. Genomic insights into the emergence and spread of international clones of healthcare-, community- and livestock-associated methicillin-resistant Staphylococcus aureus: Blurring of the traditional definitions. J Glob Antimicrob Resist. 2016 6:95-101.
²Cepheid Xpert MRSA NxG Package Insert.
³Jain et al. Veterans Affairs initiative to prevent methicillin-resistant Staphylococcus aureus infections. N Engl J Med. 2011 364:1419-30.
⁴Wassenberg et al. Costs and benefits of rapid screening of methicillin-resistant Staphylococcus aureus carriage in intensive care units: a prospective multicenter study. Crit Care. 2012 16:R22.