What's Happening?
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designations to two rapid diagnostic tests developed by NG Biotech in partnership with Hardy Diagnostics. These tests, NG-TEST® Candida auris and NG-TEST® Acineto-5®, target critical
drug-resistant pathogens identified by the World Health Organization (WHO) as high priorities. Candida auris is a multidrug-resistant yeast causing hospital outbreaks, while carbapenem-resistant Acinetobacter baumannii is a dangerous hospital-acquired bacterium. The tests are designed to provide rapid results, aiding in infection control and supporting global efforts to combat antimicrobial resistance.
Why It's Important?
Antimicrobial resistance poses a significant threat to global health, with drug-resistant infections leading to higher mortality rates and increased healthcare costs. The FDA's designation of these tests as breakthrough devices underscores the urgent need for rapid diagnostic tools to identify and manage resistant pathogens effectively. By enabling quicker detection, these tests can improve patient outcomes, reduce the spread of infections in healthcare settings, and support public health initiatives aimed at controlling antimicrobial resistance. This development represents a critical step forward in addressing a growing public health challenge.
