FDA Grants Breakthrough Device Designation to Two NG Biotech Rapid Tests Targeting the World’s Most Dangerous Drug-Resistant Pathogens

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April 1, 2026

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A designation recognizing innovation against WHO-critical fungal and bacterial threats

Santa Maria, CA, USA / Guipry, France, February 18, 2026;

In a significant recognition of innovation in the fight against Antimicrobial Resistance (AMR), NG Biotech, in partnership with Hardy Diagnostics, announced today that the U.S. Food and Drug Administration (FDA) has awarded Breakthrough Device Designations to two of its rapid diagnostic tests: NG-TEST^® Candida auris and NG-TEST^®Acineto-5^®. The two designations highlight the FDA’s assessment that both devices have the potential to address serious, life-threatening conditions and to meet critical unmet diagnostic needs in infectious disease control. These designations further strengthen the long-standing partnership between NG Biotech and Hardy Diagnostics, which already includes U.S. distribution of FDA cleared assays NG-TEST^®CARBA-5^®and NG-TEST^®CTX-M Multi.

FDA Recognition Focused on the Most Urgent Global AMR threats

Both assays target pathogens classified as critical priority by the World Health Organization (WHO):

· Candida auris, an emerging multidrug-resistant fungal pathogen associated with healthcare outbreaks, high mortality, and frequent diagnostic failure. It is part of WHO fungal priority pathogens list to guide research, development and public health action (2022).

· Acinetobacter spp., Carbapenem-Resistant Acinetobacter baumannii (CRAB) is widely recognized as a serious global health threat due to its resistance profile and ability to spread rapidly in hospitals. It is part of WHO bacterial priority pathogens list, 2024: Bacterial pathogens of public health importance to guide research, development and strategies to prevent and control AMR.

The FDA’s Breakthrough Device Designation underscores the public health importance of faster, simpler, and more reliable diagnostic tools capable of supporting early detection, outbreak monitoring, and infection-control decision-making.

NG-TEST^® Candida auris: First Rapid Immunoassay Dedicated to C. auris

NG-TEST^® Candida auris is the first lateral flow immunoassay specifically developed for rapid identification of Candida auris.

Key characteristics include :

· Rapid, ready-to-use testing from pure yeast colonies on agar plates or turbid enrichment broth*

· Results in only 15 minutes

· High reliability, with preliminary data showing 100% detection with five different clades of C. auris

· No cross reactivity with non-C. auris isolates

· Easy to implement into hospitals or public health labs to support rapid identification of C. auris in serious infections, outbreak investigation, surveillance, and infection-control programs

· Its development was supported by the French Government under the France 2030 strategic innovation program.

*Turbid broth claim not reviewed by FDA’s Breakthrough Device Designation program; available as a research use only application.

NG-TEST^® Acineto-5^®^: Rapid Detection and Differentiation of Critical Carbapenemases

NG-TEST^® Acineto-5^® is a lateral flow immunoassay designed for rapid detection and differentiation of key carbapenemase enzymes in Acinetobacter spp., including:

OXA-23-like
OXA-24/143-like
OXA-58-like
VIM
NDM

The assay delivers :

· Direct testing from Acinetobacter bacterial colonies

· Results in only 15 minutes

· High sensitivity and specificity, with no cross-reactivity to non-relevant oxacillinases

· A simple, PCR-free workflow requiring no specialized training

By significantly reducing time to results, NG-TEST^® Acineto-5^® supports laboratories focused on antimicrobial resistance monitoring and contamination risk management.

NG Biotech manufactures the tests in France, with Hardy Diagnostics serving as the exclusive U.S. distributor. Both assays have not yet received FDA 510(k) clearance. They are currently available for Research Use Only (RUO) in the United States and Worldwide as regulatory review by the FDA continues. The products have been developed in collaboration with the French Alternative Energies and Atomic Energy Commission (CEA) and with Assistance Publique – Hôpitaux de Paris (AP-HP the Greater Paris University Hospitals).

The FDA’s Breakthrough Devices Program recognizes technologies that address urgent, unmet needs in the diagnosis of life-threatening or debilitating diseases and is intended to accelerate development and regulatory review.

“These designations underscore the growing urgency around rapid detection of multidrug-resistant organisms that pose serious risks in healthcare settings” said Andre Hsiung, Chief Scientific Officer at Hardy Diagnostics. “From a scientific and public health perspective, faster and more accessible research tools are essential to strengthening surveillance efforts and improving understanding of how these organisms spread.”

“Receiving Breakthrough Device designation from the FDA is an important milestone and reflects Hardy Diagnostics’ commitment to supporting laboratories facing increasingly complex infectious disease challenges,” said Christopher Catani, President and CEO of Hardy Diagnostics. “These rapid assays are designed to integrate into laboratory workflows and support public health and infection control teams in monitoring emerging microbial threats.”

“These breakthrough designations validate both the technology behind our assays and the real-world need they address,” said Milovan Stankov-Pugès, CEO, NG Biotech. “Together, NG Biotech and Hardy Diagnostics are working to accelerate access to innovative diagnostic tools that support early detection, surveillance, and response to emerging infectious threats.”

About Hardy Diagnostics

Hardy Diagnostics is an FDA-registered manufacturer of medical devices for microbiological testing with an ISO 13485 certified Quality Management System. Hardy Diagnostics manufactures 2,700 products, distributes more than 13,000 products, offers services to more than 10,000 laboratories, exports products to over 80 foreign distributors, and maintains a network of ten distribution centers throughout the United States. Hardy Diagnostics supports the microbiology needs of clinical, pharmaceutical, cosmetics and personal care, as well as the food and beverage industries. The company is 100% owned by the employees who work there. Serving laboratory scientists since 1980, Hardy Diagnostics’ mission is to “produce and distribute the finest products for the detection of microorganisms and partner with its laboratory customers to diagnose and prevent disease.”

About NG Biotech

Founded in 2012 by pioneers in rapid diagnostics, NG Biotech is a fully integrated diagnostics company specializing in lateral flow technologies. The company designs, develops, and manufactures innovative diagnostic solutions, with end-to-end control spanning from early research and development through clinical validation and large-scale industrial deployment.

Headquartered and manufacturing in France, NG Biotech operates to the highest standards of clinical performance, quality assurance, and regulatory compliance, serving healthcare systems and partners worldwide.

NG Biotech is advancing the future of diagnostics by addressing critical unmet needs in the detection of antimicrobial resistance, emerging infectious diseases, and women’s health. Through a new generation of rapid, reliable, and multiplex diagnostic tests, the company enables timely, actionable clinical decision-making where it has the greatest impact.