New Rapid Test to Detect CTX-M Enzymes Now FDA-cleared

Rapid test provides another armament for microbiology laboratories to fight superbugs

SANTA MARIA, Calif., July 29, 2025 /PRNewswire/ -- Hardy Diagnostics is pleased to announce the FDA clearance of the NG-TEST® CTX-M Multi, an in vitro, rapid, and visual immunoassay for the qualitative detection of most prevalent CTX-M enzymes (groups 1, 2, 8, 9, and 25) from pure colonies of Enterobacterales suspected of ESBL production. This breakthrough assay rapidly confirms the presence of CTX-M enzymes in minutes, not hours.

Experience the full interactive Multichannel News Release here: https://www.multivu.com/hardy-diagnostics/9322651-en-hardy-diagnostics-ctx-m-rapid-test-fda-cleared

The rapid and widespread emergence of extended-spectrum beta-lactamases (ESBLs) is a growing global health concern. These enzymes confer resistance to many beta-lactam antibiotics, making infections more difficult to treat.

First reported in 1989 in Germany, CTX-M β-lactamases were considered rare in North America until 2003, when the Centers for Disease Control and Prevention identified them in nine Escherichia coli isolates from five U.S. states. Since then, CTX-M ESBLs have become the most prevalent type in the U.S. and globally.

Over 100 variants within the five major CTX-M groups are known, with CTX-M variants belonging to groups 1 and 9 being the most widespread. CTX-M enzymes are found in various bacterial species, including E. coli, Klebsiella pneumoniae and Proteus mirabilis.

Antibiotic resistance continues to pose significant challenges worldwide. ESBL-related infections lead to increased healthcare costs due to the use of broad-spectrum antibiotics, extended hospital stays, increased risk of side effects, and more complex treatment regimens. Early detection concurrent with the traditional antimicrobial susceptibility testing in critical cases or in instances of suspicion of resistant Enterobacterales, leading to timely treatment, and appropriate antibiotic selection are key to improving patient outcomes.

As prevalence continues to rise, so does the need for increased CTX-M ESBL testing. Detection has primarily relied on MIC and disk diffusion susceptibility testing, molecular techniques like PCR, or screening culture media. These methods can be time-consuming or expensive.

NG-TEST® CTX-M Multi offers a cost-effective and rapid solution, delivering results in just 15 minutes.

Hardy Diagnostics is the exclusive distributor of the NG-TEST® CTX-M Multi in the United States and its territories. This test joins our growing portfolio of diagnostic innovations to support better patient care through faster, targeted treatment decisions.

Learn about Hardy Diagnostics Here

Contact:
Megan Maloney Roesner  
Phone: 805.346.2766 ext. 5845
Email: [email protected]

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SOURCE Hardy Diagnostics