Lexagene Holdings Inc (fka LXXGQ)

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Another 52 week high on news here
LexaGene Provides Status Update on COVID-19 Testing at a Major Hospital Laboratory
Press Release | 06/18/2020
BEVERLY, Mass., June 18, 2020 (GLOBE NEWSWIRE) -- LexaGene Holdings, Inc., (TSX-V: LXG; OTCQB: LXXGF) (the “Company”), a biotechnology company that develops genetic analyzers for rapid pathogen detection and other molecular markers, is pleased to provide a status update on the previously announced placement of its pre-commercial LX Analyzer.

The instrument the Company placed in a major US hospital laboratory was configured to screen for COVID-19 and seven other respiratory pathogens. LexaGene’s technology performs highly multiplex RT-PCR, which is a gold-standard chemistry that provides exceptional sensitivity and specificity. LexaGene has automated the entire workflow in an instrument designed to be placed at the point-of-need. It takes less than 1 minute of hands-on time to initiate sample processing for walk-away testing.

Daryl Rebeck, LexaGene’s President and Co-Founder, states, “These have been very exciting times for LexaGene where the device has been put into the field for testing of a novel pathogen. Developing a tool for pandemic prevention is one of the main visions that Jack and I had when founding the Company four years ago. The goal was always to provide testing that can be rapidly configured in an outbreak for early detection and containment, which we can accomplish with our open-access platform to help avoid delays and supply issues associated with all the closed access testing systems in the industry. As a foremost expert in biothreat and infectious diseases, Jack’s deep knowledge makes us very well suited to provide a solution to this ongoing pandemic that has created such a significant worldwide burden.”

Dr. Jack Regan, LexaGene’s Founder and CEO, states, “From the samples tested to date, we have detected numerous positive COVID-19 samples as well as negative samples which are equally important. In contrast to many technologies that only provide a ‘yes’ or ‘no’ answer as to whether the virus was detected, LexaGene’s technology provides quantitative data on how much virus is detected. By quantifying the amount of virus present, we can help clinicians determine if a patient is possibly early in the infection cycle, late in the infection cycle, or if their immune system successfully contained the growth of the virus. In the hospital study, we have detected COVID-19 positive samples that are more than 25,000-fold different in the amount of detected virus. Quickly identifying individuals with such high viral loads is especially important for disease containment.”

Regarding the Company’s FDA plans, LexaGene has recently received comments back on its submitted plan for Emergency Use Authorization (EUA) for COVID-19 testing. Since submitting the application, the FDA has updated its template for manufacturers, changing some requirements. The Company has amended its plan and is now awaiting further communication from the FDA, which it anticipates soon. Until proposed studies are completed, and the FDA grants LexaGene’s instrument EUA for COVID-19 testing, all work using LexaGene instruments is classified as “Research Use Only” which is standard for the industry. The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain COVID-19 (or SARS-2 Coronavirus) at this time.

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On Behalf of the Board of Directors

Dr. Jack Regan
Chief Executive Officer & Director

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 return r