FDA Grants Breakthrough Designation to Two Rapid Tests for Drug-Resistant Pathogens
The fight against antimicrobial resistance (AMR) took a significant leap forward as the U.S. Food and Drug Administration (FDA) has designated two rapid diagnostic tests developed by NG Biotech, in collaboration with Hardy Diagnostics, as Breakthrough Devices. This status is granted to medical devices that have the potential to address critical medical needs and improve health outcomes.
The two tests in question are the NG-TEST® Candida auris and the NG-TEST® Acineto-5®, both of which target pathogens deemed critical by the World Health Organization (WHO). Candida auris is a multi-drug resistant yeast that has emerged as a significant health threat, especially in hospital environments, due to its high mortality rates and difficulty in detection. In 2022, it topped the WHO's list of fungal pathogens requiring urgent action. Similarly, Carbapenem-resistant Acinetobacter baumannii (CRAB) has gained notoriety as one of the most dangerous bacteria globally, given its rapid transmission in healthcare settings and alarming resistance profiles.
The NG-TEST® Candida auris is notable for being the first lateral flow immunoassay specifically designed to identify C. auris from cultured samples in just 15 minutes. This rapid identification is crucial during outbreaks, contributing significantly to infection control measures. Research has demonstrated a 100% agreement with current reference methods across various isolates, reinforcing its reliability in clinical settings.
On the other hand, the NG-TEST® Acineto-5® is engineered to detect and differentiate five significant Carbapenemase families—OXA-23-like, OXA-24/143-like, OXA-58-like, VIM, and NDM—directly from Acinetobacter specimens. Delivering results within 15 minutes, this test forgoes the need for complex PCR equipment, ensuring that it is user-friendly and accessible in critical healthcare environments.
Milovan Stankov-Pugès, the CEO of NG Biotech, emphasized the importance of the Breakthrough Device status, stating that it validates the technology behind their assays and highlights the immediate health needs they aim to address. Andre Hsiung, the Chief Scientific Officer at Hardy Diagnostics, echoed this sentiment, pointing out the urgent need for rapid detection of multi-resistant organisms that pose severe risks in healthcare facilities.
Currently, these tests, developed and manufactured in France by NG Biotech, are exclusively distributed in the United States by Hardy Diagnostics. They are available solely for research purposes while the FDA process continues. The swift identification of high-risk pathogens provided by these Breakthrough Devices is anticipated to enhance surveillance efforts, inform infection control decisions, and augment global initiatives aimed at combating antibiotic resistance.
As antibiotic resistance continues to threaten public health and patient safety worldwide, innovations like these tests are pivotal. They not only facilitate rapid response during outbreaks but also play a vital role in protecting healthcare resources and improving patient outcomes in critical care settings. The collaboration between NG Biotech and Hardy Diagnostics demonstrates a proactive approach to an escalating public health crisis, paving the way for future advancements in diagnostics aimed at emerging and re-emerging infectious diseases.
The two tests in question are the NG-TEST® Candida auris and the NG-TEST® Acineto-5®, both of which target pathogens deemed critical by the World Health Organization (WHO). Candida auris is a multi-drug resistant yeast that has emerged as a significant health threat, especially in hospital environments, due to its high mortality rates and difficulty in detection. In 2022, it topped the WHO's list of fungal pathogens requiring urgent action. Similarly, Carbapenem-resistant Acinetobacter baumannii (CRAB) has gained notoriety as one of the most dangerous bacteria globally, given its rapid transmission in healthcare settings and alarming resistance profiles.
The NG-TEST® Candida auris is notable for being the first lateral flow immunoassay specifically designed to identify C. auris from cultured samples in just 15 minutes. This rapid identification is crucial during outbreaks, contributing significantly to infection control measures. Research has demonstrated a 100% agreement with current reference methods across various isolates, reinforcing its reliability in clinical settings.
On the other hand, the NG-TEST® Acineto-5® is engineered to detect and differentiate five significant Carbapenemase families—OXA-23-like, OXA-24/143-like, OXA-58-like, VIM, and NDM—directly from Acinetobacter specimens. Delivering results within 15 minutes, this test forgoes the need for complex PCR equipment, ensuring that it is user-friendly and accessible in critical healthcare environments.
Milovan Stankov-Pugès, the CEO of NG Biotech, emphasized the importance of the Breakthrough Device status, stating that it validates the technology behind their assays and highlights the immediate health needs they aim to address. Andre Hsiung, the Chief Scientific Officer at Hardy Diagnostics, echoed this sentiment, pointing out the urgent need for rapid detection of multi-resistant organisms that pose severe risks in healthcare facilities.
Currently, these tests, developed and manufactured in France by NG Biotech, are exclusively distributed in the United States by Hardy Diagnostics. They are available solely for research purposes while the FDA process continues. The swift identification of high-risk pathogens provided by these Breakthrough Devices is anticipated to enhance surveillance efforts, inform infection control decisions, and augment global initiatives aimed at combating antibiotic resistance.
As antibiotic resistance continues to threaten public health and patient safety worldwide, innovations like these tests are pivotal. They not only facilitate rapid response during outbreaks but also play a vital role in protecting healthcare resources and improving patient outcomes in critical care settings. The collaboration between NG Biotech and Hardy Diagnostics demonstrates a proactive approach to an escalating public health crisis, paving the way for future advancements in diagnostics aimed at emerging and re-emerging infectious diseases.
Topics Health）
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