FDA Designates Two Rapid Tests as Breakthrough Devices in Fight Against Antimicrobial Resistance

FDA's Breakthrough Device Designation for Rapid Testing

In a significant step towards combating antimicrobial resistance (AMR), the U.S. Food and Drug Administration (FDA) has bestowed the Breakthrough Device Designation on two rapid diagnostic tests developed by NG Biotech, in collaboration with Hardy Diagnostics. These innovations, namely NG-TEST® Candida auris and NG-TEST® Acineto-5®, aim to effectively identify critical antibiotic-resistant pathogens that pose severe threats to patient safety in healthcare settings.

Unveiling the Tests

NG-TEST® Candida auris

The first of the two, NG-TEST® Candida auris, stands out as the inaugural rapid lateral flow immunoassay specifically engineered to detect the multidrug-resistant yeast, Candida auris, within a mere 15 minutes from cultured samples. This pathogen has emerged as a leading concern in global healthcare, notorious for causing outbreaks in hospitals and exhibiting high mortality rates due to its resistance profile, making swift identification crucial. Published data showcases an impressive 100% agreement with conventional reference methods across various isolates, reinforcing its reliability for outbreak investigations and infection control scenarios.

NG-TEST® Acineto-5®

On the other hand, NG-TEST® Acineto-5® offers a unique solution by detecting and distinguishing five major families of carbapenemases — specifically, OXA-23-like, OXA-24/143-like, OXA-58-like, VIM, and NDM — directly from Acinetobacter samples. Also yielding results in just 15 minutes, this test is designed for user-friendliness, requiring no specialized equipment, thereby enhancing its accessibility for a range of healthcare facilities.

Addressing Urgent Healthcare Needs

Milovan Stankov-Pugès, CEO of NG Biotech, expressed the significance of these Breakthrough Designations, emphasizing the critical need for rapid detection technologies that address life-threatening infections caused by multidrug-resistant organisms. He stated, “These designations validate the technology underlying our tests and the actual need they fulfill.”

Andre Hsiung, Chief Scientific Officer of Hardy Diagnostics, added that this designation highlights the increasing urgency surrounding the rapid identification of resistant organisms that pose serious risks in healthcare environments.

Developed and manufactured in Guipry, France, both tests are currently distributed exclusively in the United States by Hardy Diagnostics and are available for research purposes only while the FDA finalizes its review.

The Impact of Rapid Detection

By accelerating the identification of high-risk pathogens, these designated breakthrough devices aim to bolster infection control strategies and support global efforts to combat antimicrobial resistance. The swift detection capabilities of NG Biotech's tests are poised to play a crucial role in enhancing healthcare responses to the growing threat of AMR, ultimately preserving patient lives and improving overall public health outcomes.

As healthcare systems worldwide grapple with the challenges posed by AMR, the emergence of such innovative diagnostic tools heralds a new era of proactive infection management and underscores the critical importance of rapid response mechanisms in modern medical practice.