FDA Clears Luminex Corporation’s Aries C. difficile Assay

Luminex Corporation announced that it has received FDA clearance for the ARIES C. difficile Assay, a moderate complexity, sample to answer test for rapid detection of C. difficile. The ARIES C. difficile Assay detects both toxin A and toxin B, which may reduce the probability of a false negative result from strains that only produce toxin A. This milestone continues the company’s track record of a rapid succession of regulatory clearances for assays on the ARIES Systems, such as Bordetella, GBS, and Norovirus CE-IVD earlier this year.
 
The CDC has classified Clostridium difficile (C. difficile) as an ‘Urgent’ threat requiring more monitoring and prevention activities, in part because it has become the most common microbial cause of healthcare-associated infections in U.S. hospitals. A 2015 CDC study found that C. difficile caused almost half a million infections among patients in the United States in a single year. An estimated 15,000 annual deaths are directly attributable to C. difficile infections, making it a substantial cause of infectious disease death in the United States.
 
Dr. Ray Widen, Scientific Director, Esoteric Testing and R&D at Tampa General Hospital, commented: “C. difficile infections have become more frequent, severe and difficult to manage in recent years, increasing our need for better tools to diagnose and treat these debilitating and life threatening infections. This includes the ability to detect both toxin A and B genes of the bacterium. The ARIES C. difficile Assay was easy to use and performed very well in our lab during the clinical trial. The combination of a simple workflow for ease of training, sample in/answer out capabilities for ease of use, rapid time to result, and flexible batch size, makes the ARIES System a good fit for routine microbiology laboratories that may not have prior experience with molecular assays.”
 
“With this regulatory approval, we are further broadening our infectious diseases testing portfolio and adding to our rapidly growing menu of targeted assays and customized panels,” said Homi Shamir, president and CEO of Luminex. “We are very pleased to offer a new solution to hospitals and molecular testing labs that can help improve their ability to test for these serious infections. From GI to respiratory, blood culture to women’s health, we are making a true difference in the delivery of healthcare with the rapid number of high quality products we are bringing to market, including four new tests for the ARIES System already this year.”
 
The ARIES System is designed to run in multiple laboratory shifts and allows labs to simultaneously run both IVD and LDT assays in a sample to answer format when using a Universal Assay Protocol. All aspects of testing are automated, from sample preparation through analysis, providing answers in less than 2 hours with minimal hands-on time while enabling easy implementation on weekends and night shifts. The ARIES C. difficile Assay, a real-time polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test, is part of Luminex’s comprehensive gastroenterological testing menu that also includes the xTAG Gastrointestinal Pathogen Panel (GPP), VERIGENE Enteric Pathogens Test (EP), and the ARIES Norovirus Assay CE-IVD.