NEW YORK – Luminex said today that the US Food and Drug Administration has granted 510(k) clearance for its the real-time PCR-based Aries MRSA Assay running on its Aries sample-to-answer system.
The FDA has cleared the test for the direct detection of methicillin-resistant Staphylococcus aureus DNA from nasal swabs in patients at risk for nasal colonization.
"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 [US] Centers for Medicare & Medicaid Services' Hospital-Acquired Condition Reduction Program," Luminex CEO and President Homi Shamir said in a statement. "Together, these assays have the potential to significantly reduce healthcare-acquired infections and greatly improve patient care and outcomes."
Citing the US Centers for Disease Control and Prevention, Luminex said that MRSA causes more than 80,000 severe infections and kills more than 11,000 people in the US each year.
By reducing the unnecessary use of antimicrobial therapies, allowing for more effective patient management, rapid molecular tests, including the Aries MRSA Assay, can be a vital tool to aid physicians, Luminex noted.
The firm said that its Aries real-time system can run six FDA-cleared assays and seven assays that have the CE-IVD mark, as well as laboratory-developed tests.