Cepheid Announces FDA Clearance of Next-Generation Test for MRSA Colonization

SUNNYVALE, Calif.Dec. 19, 2016 /PRNewswire/ -- 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 our Diagnostics First education campaign, visit www.DiagnosticsFirst.com. Xpert® MRSA NxG will begin shipping in December. For more information on Cepheid's GeneXpert® Systems or the complete menu of Xpert tests, visit www.cepheidinternational.com

About Cepheid

Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit www.cepheid.com.

About GeneXpert Systems and Xpert Tests

With more than 11,000 systems in 182 countries, the GeneXpert System is the world's most popular molecular diagnostics' system.  The GeneXpert System's modular configuration means that the system is the most scalable available, offering the ability to perform from one to eighty Xpert tests at the same time. As a result, the GeneXpert System meets the throughput requirements of customers of all sizes - from lower volume point-of-care settings to higher volume reference laboratories - enabling accurate, fast and cost effective test results.

GeneXpert Systems run proprietary Xpert test cartridges. The Xpert test menu spans healthcare-associated infections, sexual health, critical infectious disease, and oncology, and today offers 24 tests outside the US, and 20 tests in the US. More information on the GeneXpert System and the Xpert tests is available on our website at www.cepheid.com

References:

  1. Bal 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.
  2. Cepheid Xpert MRSA NxG Package Insert.
  3. Jain et al. Veterans Affairs initiative to prevent methicillin-resistant Staphylococcus aureus infections. N Engl J Med. 2011 364:1419-30.
  4. Wassenberg 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.

Contact: 
Darwa Peterson 
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