Rapid Test Promises Faster Answers for Drug-Resistant Infections

Candida auris is notoriously difficult to identify and has been linked to hospital-wide outbreaks, while carbapenem-resistant Acinetobacter baumannii can spread rapidly in clinical settings.

A new pair of rapid lateral-flow assays has now received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA), enabling 15-minute identification of Candida auris and differentiation of key carbapenemases in Acinetobacter to support faster infection control and treatment decisions.

NG Biotech (Guipry, France), in partnership with Hardy Diagnostics (Santa Maria, CA, USA), announced Breakthrough Device designation for NG-TEST Candida auris and NG-TEST Acineto-5. Both assays target pathogens classified as critical by the World Health Organization (WHO). Developed and manufactured in France by NG Biotech and distributed exclusively in the United States by Hardy Diagnostics, the tests are currently available for research use only while U.S. regulatory review continues.

NG-TEST Candida auris is the first lateral-flow immunoassay specifically designed to identify C. auris from cultured specimens within 15 minutes. Published data cited in the announcement report 100% agreement with reference methods across diverse isolates. These attributes position the assay for use in outbreak investigations and infection control programs where rapid confirmation from cultures is required.

NG-TEST Acineto-5 detects and differentiates five major carbapenemase families—OXA‑23‑like, OXA‑24/143‑like, OXA‑58‑like, VIM, and NDM—directly from Acinetobacter samples, delivering results within 15 minutes. The assay is PCR-free and designed for straightforward use without specialized equipment. Carbapenem-resistant A. baumannii, listed by the World Health Organization among priority bacterial pathogens, poses a high risk in hospitals due to its resistance profile and rapid transmission.

By accelerating detection of high‑risk pathogens, the assays are intended to enhance surveillance and guide infection control decisions while broader regulatory evaluation proceeds. The companies emphasize the role of rapid results in supporting global efforts against antimicrobial resistance.

"These breakthrough designations validate both the technology behind our assays and the real-world need they address," said Milovan Stankov-Pugès, CEO, NG Biotech.

"The designation underscores the growing urgency around rapid detection of multidrug-resistant organisms that pose serious risks in healthcare settings," said Andre Hsiung, Chief Scientific Officer of Hardy Diagnostics.

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NG Biotech
Hardy Diagnostics