LexaGene Approved by CDC and FDA Antibiotic Resistance Isolate Bank to Receive Samples to Test for Superbugs
BEVERLY, Mass. – July 30, 2019 – LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (the “Company”), a biotechnology company that develops genetic analyzers for pathogen detection and other molecular markers, announced today that it has been recognized by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) Antibiotic Resistance (AR) Isolate Bank as an institution approved to receive samples for testing antibiotic resistance.
The CDC and FDA AR Isolate Bank will provide information to LexaGene which will support the Company’s diagnostics development and help address the serious issue of antibiotic resistance, including 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.
Dr. Jack Regan, LexaGene’s CEO and Founder states, “LexaGene now has a formal relationship with the CDC and FDA, two agencies that view antimicrobial resistance to be the biggest health threat of our time. We will leverage this relationship to improve the performance of our technology. Antibiotic resistant pathogens are predicted to kill 10 million people by 20501. To avoid this dreadful prediction, we need better diagnostics to improve our antibiotic stewardship and to lower the potential for contagion transmission.”
The CDC has one of the largest collections of pathogens that have been acquired over the years from reference laboratories across the United States. Some of these pathogens represent a significant risk to public health and designing high quality tests to better detect them is of critical importance.
“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,” says Dr. Nathan Walsh, LexaGene’s VP of Applications and Bio-Informatics.
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About LexaGene Holdings Inc.
LexaGene is a biotechnology company that develops genetic analyzers for pathogen detection and other molecular markers for on-site rapid testing in veterinary diagnostics, food safety and for use in open-access markets such as clinical research, agricultural testing and biodefense. End-users simply need to collect a sample, load it onto the instrument with a sample preparation cartridge, and press ‘go’. The LX Analyzer delivers excellent sensitivity, specificity, and breadth of detection and can process multiple samples at a time, in an on-demand fashion, returning results in about 1 hour. The unique open-access feature is designed for custom testing so that end-users can load their own real-time PCR assays onto the instrument to target any genetic target of interest.
About the CDC and FDA AR Isolate Bank
The CDC and FDA AR Isolate Bank provides curated collections of resistant organisms to help microbiologists, drug and diagnostic manufacturers, and researchers combat one of the world’s greatest infectious disease threats2. As of January 2018, more than 2,000 isolate panels have been shipped. The panels strengthen diagnostics by validating lab tests, inform research and development to develop drugs like antibiotics and antifungals, develop diagnostic devices, tests, and assays, satisfy requests and support applications to the FDA, perform testing to ensure drug effectiveness, study biology and pathogenic mechanisms, and detect new and unusual public health resistance threats3. For more information, visit AR Isolate Bank.
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This news release contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors — including the availability of funds, the results of financing efforts, the success of technology development efforts, the cost to procure critical parts, performance of the instrument, market acceptance of the technology, regulatory acceptance, and licensing issues — that could cause actual results to differ materially from the Company’s expectations as disclosed in the Company’s documents filed from time to time on SEDAR (see www.sedar.com). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.