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Home Drug Development Clinical Trials

LexaGene to Place Beta Unit in Human Clinical Diagnostics Laboratory

Content Team by Content Team
14th August 2019
in Clinical Trials, Manufacturing, News
LexaGene Human Clinical Diagnostics

LexaGene Holdings, Inc. , a biotechnology company that develops genetic analyzers for rapid pathogen detection and other molecular markers, announced  it has an agreement to place a beta prototype with Assurance Scientific Laboratories (ASL) in Vestavia, Alabama in August 2019.  ASL is a certified reference laboratory specializing in providing clinical testing results to physicians nationwide.

ASL currently processes over 300 urine samples per week for human urinary tract infections – plus hundreds of other sample types.  The beta test will focus on testing urine samples to detect the presence of pathogens causing urinary tract infections while simultaneously screening these samples for genetic markers for antimicrobial resistance. ASL has expertise in developing and testing for antimicrobial resistance genes using PCR-based tests.  Antimicrobial resistance – the resistance of bacteria, fungus, and viruses to drugs – is a worldwide problem that could cause 10 million deaths each year by 2050.1

Dr. Nathan Walsh, LexaGene’s VP of Applications and Bio-Informatics states, “During this beta test period, ASL will take advantage of the open-access feature of LexaGene’s LX technology to compare our tests to their tests for pathogen identification and antimicrobial resistance characterization. The research data generated will help clinical laboratories better assess the available tools to aid in the diagnosis and treatment of human urinary tract infections.”

At ASL, Mary Beth Minyard, Director of Microbiology, and Dr. Greer Massey, Director of Molecular Diagnostics, will lead the project. “We are always looking for new technology to help us streamline sample processing and analysis. We are excited to evaluate LexaGene’s LX technology, especially for its integrated sample extraction, test assembly, and analysis which has the potential to expedite sample processing in the lab, lower costs and minimize errors,” states Massey.

Dr. Jack Regan, CEO and Founder of LexaGene states, “Our open-access technology differentiates us from other automated molecular testing technologies. This collaborative effort with ASL, a reference laboratory that processes human samples for clinical diagnostic testing, is a perfect example of a laboratory taking advantage of the open-access feature to test the performance of their own assays on our fully automated analyzer. We are excited to have this opportunity to demonstrate the instrument’s capabilities, and how it may someday be used for human clinical diagnostics.”

To be added to the LexaGene email distribution list, please subscribe on the Company website.

https://www.who.int/news-room/detail/29-04-2019-new-report-calls-for-urgent-action-to-avert-antimicrobial-resistance-crisis

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, enter sample ID 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 Assurance Scientific Laboratories

Assurance Scientific Laboratories (ASL) is comprised of a passionate team of medical doctors and scientists who believe in using the best objective data available to help health care providers make accurate and timely diagnoses. Our mission is to provide healthcare providers with Assurance to treat their patients in the best manner possible. We specialize in molecular, microbiology, and toxicology assays and technology.  ASL is also a CDC ARLab Partner that works with the CDC to develop diagnostic tools to better identify emerging antibiotic resistance. For more information, visit Assurance Scientific Laboratories.

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