Luminex (LMNX) announced that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ARIES® MRSA Assay. The assay is an integrated, real-time, polymerase chain reaction (PCR) based, qualitative, in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization.
“MRSA causes more than 80,000 severe infections and kills more than 11,000 people in the U.S. each year. The 510(k) clearance of our ARIES® MRSA Assay marks an exciting moment for our ARIES® product line and, most importantly, for patients throughout the United States,” said Homi Shamir, President and CEO of Luminex. “In conjunction with our previously cleared ARIES® C. difficile Assay, this clearance empowers healthcare facilities to perform rapid, targeted testing for the two critical pathogens identified by The Centers for Medicare & Medicaid Services’ Hospital-Acquired Condition Reduction Program (HACRP). Together, these assays have the potential to significantly reduce healthcare acquired infections and greatly improve patient care and outcomes.”
According to the U.S. Centers for Disease Control and Prevention, approximately one in 50 people in the U.S. is colonized with MRSA in their nose. This means there are approximately 6.6 million carriers of MRSA in the United States. Rapid molecular tests, including the ARIES® MRSA Assay, can be a vital tool to aid physicians in reining in the spread of antimicrobial resistance and the associated negative outcomes for both patients and healthcare facilities, by reducing the unnecessary use of antimicrobial therapies, allowing for more effective patient management.
The Luminex ARIES® System is a sample to answer, real-time instrument designed to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into the modern laboratory. The system features six FDA and seven CE-IVD cleared assays, as well as the ability to run laboratory-developed tests. “This assay adds another foundational test to our ARIES® platform, increasing its value for customers and patients,” said Mr. Shamir.
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