FDA Grants Innovative Device Designation for Two Rapid Tests Targeting Drug-Resistant Pathogens
In a remarkable milestone in the fight against antimicrobial resistance (AMR), the U.S. Food and Drug Administration (FDA) has granted innovative device designations to two rapid diagnostic tests developed by NG Biotech in partnership with Hardy Diagnostics. These two tests, the NG-TEST® Candida auris and NG-TEST® Acineto-5®, are designed to identify critical drug-resistant pathogens that pose significant public health threats. This recognition from the FDA underscores the urgency in developing detection technologies that can combat dangerous infections effectively and efficiently.
The NG-TEST® Candida auris focuses on identifying Candida auris, a multidrug-resistant yeast that has been associated with serious outbreaks in healthcare settings around the world. Listed on the World Health Organization's (WHO) Priority Fungal Pathogens List in 2022, Candida auris is notorious for being difficult to detect and has a high mortality rate. This novel test is the first lateral flow immunoassay specifically designed to detect C. auris from cultured samples in just 15 minutes, showing a 100% accuracy rate compared to reference methods across various isolates. This rapid detection capability is critical for infection control and outbreak investigations in hospitals and healthcare facilities.
The second test, NG-TEST® Acineto-5®, targets Acinetobacter baumannii (CRAB), a carbapenem-resistant pathogen ranked among the most hazardous nosocomial bacteria by the WHO. This innovative assay can detect and differentiate five major families of carbapenemases directly from Acinetobacter samples and also delivers results in 15 minutes. Importantly, it operates without the need for PCR technology, making it user-friendly and accessible for healthcare professionals without specialized equipment.
Milovan Stankov-Pugès, CEO of NG Biotech, emphasized that these designations validate the technology behind the tests and address real-world healthcare needs. The need for rapid detection of multidrug-resistant organisms is becoming increasingly urgent as they pose severe risks in healthcare environments. Hardy Diagnostics' Chief Scientific Officer, Andre Hsiung, echoed this sentiment, highlighting the importance of expedited detection in infection control measures.
Both tests are U.S.-made and produced in France by NG Biotech, with Hardy Diagnostics serving as the sole distributor in the U.S. Currently, they are available only for research use pending further FDA review. The introduction of these rapid tests aims to enhance surveillance, guide infection control decisions, and contribute to global efforts against antimicrobial resistance, thus addressing a critical gap in public health.
For further information regarding NG Biotech and Hardy Diagnostics, interested parties can visit their respective websites or contact their media relations representatives. As antimicrobial resistance continues to challenge healthcare systems globally, innovations like these rapid tests are essential tools in combating this pressing issue. Their expedited detection capabilities are anticipated to significantly bolster infection prevention strategies, ensuring better patient outcomes and healthier communities overall.
The NG-TEST® Candida auris focuses on identifying Candida auris, a multidrug-resistant yeast that has been associated with serious outbreaks in healthcare settings around the world. Listed on the World Health Organization's (WHO) Priority Fungal Pathogens List in 2022, Candida auris is notorious for being difficult to detect and has a high mortality rate. This novel test is the first lateral flow immunoassay specifically designed to detect C. auris from cultured samples in just 15 minutes, showing a 100% accuracy rate compared to reference methods across various isolates. This rapid detection capability is critical for infection control and outbreak investigations in hospitals and healthcare facilities.
The second test, NG-TEST® Acineto-5®, targets Acinetobacter baumannii (CRAB), a carbapenem-resistant pathogen ranked among the most hazardous nosocomial bacteria by the WHO. This innovative assay can detect and differentiate five major families of carbapenemases directly from Acinetobacter samples and also delivers results in 15 minutes. Importantly, it operates without the need for PCR technology, making it user-friendly and accessible for healthcare professionals without specialized equipment.
Milovan Stankov-Pugès, CEO of NG Biotech, emphasized that these designations validate the technology behind the tests and address real-world healthcare needs. The need for rapid detection of multidrug-resistant organisms is becoming increasingly urgent as they pose severe risks in healthcare environments. Hardy Diagnostics' Chief Scientific Officer, Andre Hsiung, echoed this sentiment, highlighting the importance of expedited detection in infection control measures.
Both tests are U.S.-made and produced in France by NG Biotech, with Hardy Diagnostics serving as the sole distributor in the U.S. Currently, they are available only for research use pending further FDA review. The introduction of these rapid tests aims to enhance surveillance, guide infection control decisions, and contribute to global efforts against antimicrobial resistance, thus addressing a critical gap in public health.
For further information regarding NG Biotech and Hardy Diagnostics, interested parties can visit their respective websites or contact their media relations representatives. As antimicrobial resistance continues to challenge healthcare systems globally, innovations like these rapid tests are essential tools in combating this pressing issue. Their expedited detection capabilities are anticipated to significantly bolster infection prevention strategies, ensuring better patient outcomes and healthier communities overall.
Topics Health）
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