NG Biotech and Hardy Diagnostics Secure FDA Breakthrough for AMR Assays

The granting of Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) to NG Biotech and Hardy Diagnostics for their NG-TEST Candida auris and NG-TEST Aci assays marks a pivotal moment in the fight against antimicrobial resistance (AMR). This designation is a specialized status reserved for medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. By fast-tracking these specific assays, the FDA is acknowledging the critical gap in current diagnostic capabilities for two of the most dangerous pathogens found in modern healthcare settings, signaling an urgent need for faster, more accurate tools to identify pathogens that have become increasingly resistant to traditional treatments.

The first target, Candida auris, is a multidrug-resistant yeast that has become a global health concern due to its ability to cause invasive infections with high mortality rates. One of the most challenging aspects of C. auris is its persistence on surfaces and its tendency to spread rapidly within hospitals and nursing homes. Traditional identification methods often misidentify the fungus or require specialized laboratory equipment and days of culture time. During this delay, an infected patient can unknowingly transmit the pathogen to others. The NG-TEST Candida auris assay utilizes lateral flow technology to identify the pathogen in a fraction of the time, allowing for the immediate implementation of contact precautions and targeted antifungal therapy.

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Food and Drug Administration (FDA) to NG Biotech and Hardy Diagnostics for their NG-TEST Candida auris and NG-TEST Aci assays marks a pivotal moment in the fight against antimicrobial resistance (AMR).

Similarly, Acinetobacter baumannii, often referred to as Aci, is a Gram-negative bacterium that frequently causes healthcare-associated infections, particularly in intensive care units. Many strains of Aci have developed resistance to nearly all available antibiotics, including carbapenems, which are often considered the last line of defense. The NG-TEST Aci assay is designed to detect specific resistance markers or the bacteria itself rapidly, providing clinicians with actionable data much sooner than conventional microbiology techniques. This shift from wait-and-see empiric prescribing to test-and-treat precision medicine is the cornerstone of modern diagnostic stewardship.

The strategic partnership between NG Biotech, a French innovator in rapid diagnostics, and Hardy Diagnostics, an established American manufacturer, is essential for the successful deployment of these tools. Hardy Diagnostics provides the logistical infrastructure and market presence necessary to navigate the complex U.S. healthcare landscape. For NG Biotech, the Breakthrough Designation provides a direct line of communication with FDA reviewers, potentially shaving months or even years off the traditional regulatory timeline. This collaborative effort reflects a broader trend in the medical device industry where international R&D expertise is paired with domestic distribution power to address urgent public health needs.

From a market perspective, the demand for rapid AMR diagnostics is expected to grow significantly as health systems face increasing pressure to reduce hospital-acquired infections (HAIs) and improve patient outcomes. The economic burden of AMR is substantial, driven by prolonged hospital stays and the high cost of treating resistant infections. While rapid tests may have a higher per-unit cost than traditional culture plates, the total cost of care is often lower when accounting for the prevention of outbreaks and more efficient use of expensive antibiotics. Investors and health system administrators should view this FDA milestone as a signal that the regulatory environment is tilting in favor of high-impact, rapid-result technologies.

Looking forward, the industry will be watching the clinical trial data that emerges from the continued development of these assays. The success of the NG-TEST platform could pave the way for a broader suite of rapid tests targeting other high-priority pathogens, such as carbapenem-resistant Enterobacteriaceae (CRE). As the FDA continues to utilize the Breakthrough Device program to incentivize innovation in the AMR space, the transition toward decentralized, near-patient testing will likely accelerate, fundamentally changing how infectious diseases are managed in the clinical setting.