LexaGene Nabs CDC and FDA Approval for New Antibiotic Resistance Test

Antibiotic resistance

With increasing concerns over the rise of drug-resistant pathogens wreaking havoc on the healthcare system, a new genetics analyzer diagnostics tool has been developed that can detect antibiotic-resistant genes in a pathogen within just one hour.

Massachusetts-based LexaGene Holdings announced Monday that both the U.S. Centers for Disease Control and Prevention (CDC), as well as the U.S. Food and Drug Administration (FDA)’s Antibiotic Resistance Isolate Bank, recognized the company as an institution approved to receive samples for testing antibiotic resistance. According to the World Health Organization, drug-resistant infections result in approximately 700,000 deaths per year. LexaGene said the CDC and the FDA AR Isolate Bank will provide the company with the information it requires to conduct the testing in order to address the serious issue of antibiotic resistance, including so-called “superbugs.” With this approval, LexaGene has access to an enormous repository of fully characterized pathogens, which the company will use to continually improve the detection capabilities of its LX Analyzer.

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Jack Regan, LexaGene’s chief executive officer, called drug-resistant pathogens the “biggest health threat” of our time. The CDC has one of the largest collections of pathogens and Regan noted that some of these pathogens represent a significant risk to public health. Designing high-quality tests to better detect them is of critical importance, he said.

“Antibiotic-resistant pathogens are predicted to kill 10 million people by 2050. To avoid this dreadful prediction, we need better diagnostics to improve our antibiotic stewardship and to lower the potential for contagion transmission,” Regan said in a statement.

Over the past few years, there have been multiple stories about the rise of drug-resistant pathogens. Recently, a dangerous fungal infection known as Candida auris reared its head in a New York hospital. The facility had to tear out part of the room a patient was housed in due to the spread of the fungal infection, which can be fatal. With growing concerns about the rise of drug-resistant bacteria, multiple companies are developing new forms of antimicrobials to take on serious health concerns, such as carbapenem-resistant enterobacteriaceae, Clostridium difficile, better known as C. diff, or Staphylococcus infections.

Regan noted that the CDC and FDA approval will allow his company to boost the capabilities of LexeGene’s technology and fight drug-resistant infections. LexaGene’s analyzer has an “open access” structure, which means it has been designed to “service the evolving reality of antibiotic resistance.” New tests can be continuously developed as new pathogens evolve and these tests and can be run on the same device as well as shared with other LexaGene device owners around the world.

“Previously, we demonstrated success in detecting pathogens and antibiotic resistance, and with this approval, we gain access to many more pathogens than we had before. We will use these strains to make our testing as robust as possible. LexaGene is committed to improving antibiotic stewardship by providing healthcare providers with the information they need to quickly determine whether antibiotics are needed and if so, guide the prescription based on whether resistance factors are detected,” Nathan Walsh, LexaGene’s head of applications and bio-informatics said in a statement.

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