What's Happening?
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designations to two rapid diagnostic assays developed by NG Biotech in partnership with Hardy Diagnostics. These assays, NG-TEST® Candida auris and NG-TEST® Acineto-5®, are designed
to detect critical drug-resistant pathogens. Candida auris, a multidrug-resistant yeast, is known for causing hospital outbreaks and is difficult to detect, while Carbapenem-resistant Acinetobacter baumannii (CRAB) is a highly resistant bacterium prevalent in healthcare settings. The tests provide results in 15 minutes and are currently available for Research Use Only as FDA review continues.
Why It's Important?
The designation of these tests as breakthrough devices underscores the urgent need for rapid detection of multidrug-resistant organisms, which pose significant risks in healthcare environments. By enabling quicker identification of these pathogens, the tests can enhance infection control measures and support global efforts to combat antimicrobial resistance. This development is crucial for healthcare providers, as it could lead to improved patient outcomes and reduced transmission of these dangerous pathogens in hospitals.
What's Next?
As the FDA review process continues, the tests are expected to play a significant role in strengthening surveillance and guiding infection control decisions. The successful implementation of these assays could lead to broader adoption in healthcare settings, potentially influencing policy changes regarding the management of drug-resistant infections. Stakeholders in the healthcare industry will likely monitor the progress of these tests closely, as their approval and widespread use could mark a significant advancement in the fight against antimicrobial resistance.
