LexaGene Holdings Secures CDC and FDA Approval to Access Comprehensive Pathogen Repository for Antibiotic Resistance Testing

On August 6, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that biotechnology company LexaGene Holdings announced it had received approval from the U.S. Centers for Disease Control and Prevention (CDC) and the FDA AR Isolate Bank (FDA Antibiotic Resistance Isolate Bank) to receive samples for antibiotic resistance testing.

LexaGene, founded on October 12, 2016, and headquartered in Beverly, Massachusetts, USA, is a biotechnology company and one of the top 50 enterprises listed on the TSX Venture Exchange. The company is developing the LX Analyzer, the first fully automated pathogen detection platform, positioning itself as a pioneer in pathogen diagnostics and sample analysis. The LX Analyzer enables rapid point-of-care testing in open environments for applications including veterinary diagnostics, food safety, clinical research, agricultural testing, water quality monitoring, and pathogen surveillance in aquaculture. End users need only collect a sample, place it into the sample preparation cartridge, load the cartridge into the instrument, and press the “Go” button to initiate the test.

LexaGene stated that the CDC and FDA AR Isolate Bank will provide the company with the information necessary for testing to address a range of antibiotic resistance issues, including those involving “superbugs.” Upon approval, LexaGene will gain access to an extensive pathogen repository, which the company will leverage to continuously enhance the detection capabilities of its LX Analyzer.

The LX Analyzer offers excellent sensitivity and specificity, along with a wide detection range. It can process multiple samples simultaneously according to user requirements, delivering results in approximately one hour. Its unique open-access feature is designed for customized testing, allowing end users to upload their own real-time PCR (polymerase chain reaction) test results to the instrument.

Recently, a dangerous fungal infection caused by Candida has emerged in a hospital in New York. Due to the spread of the fungal infection, which is fatal, the hospital was forced to demolish parts of its patient rooms. As concerns about drug-resistant bacteria continue to grow, several companies are developing new antimicrobial agents to address serious health threats posed by pathogens such as carbapenem-resistant Enterobacteriaceae, Clostridioides difficile (C. diff), and Staphylococcus.

According to the World Health Organization, drug-resistant infections cause approximately 700,000 deaths annually. The U.S. Centers for Disease Control and Prevention (CDC) maintains one of the world’s largest pathogen repositories, some of which pose significant threats to public health. Therefore, designing high-quality testing instruments to better detect these pathogens is of paramount importance.

Dr. Jack Regan, CEO and Founder of LexaGene, stated, “We believe that antibiotic resistance is the greatest health threat of our time. LexaGene has now established partnerships with the CDC and the FDA, and we will leverage these relationships to enhance the performance of our technology. It is projected that by 2050, antibiotic-resistant pathogens will cause 10 million deaths. To prevent this dire prediction from becoming a reality, we need better diagnostic technologies to improve our antibiotic stewardship and reduce the likelihood of transmitting infectious bacteria.”

“LexaGene’s analyzer features an ‘open-access’ architecture, meaning it is designed to address the evolving reality of antibiotic resistance. As new pathogens emerge, new assays can be continuously developed and run on the same instrument, or shared with other LexaGene users worldwide,” added Dr. Jack Regan. He noted that CDC and FDA clearance will enhance the capabilities of LexaGene’s technology in combating drug-resistant infections.

“Previously, we achieved significant success in detecting pathogens and antibiotic resistance. Following approval from the CDC and the FDA AR Isolate Bank, we gained access to a broader range of pathogens than ever before. We will leverage these strains to refine our tests to the greatest extent possible,” said Nathan Walsh, Head of Applications and Bioinformatics at LexaGene, in a statement. “LexaGene is committed to improving antibiotic stewardship by providing healthcare providers with the information they need to determine whether antibiotics are necessary and, if so, to guide prescribing based on detected resistance factors.”

(Compiled by Cheng Tao)