LexaGene Holdings Inc (CVE:LXG) (OTCQB:LXXGF) said it is seeing good results after its LX Analyzer pathogen detection device was configured to screen for coronavirus (COVID-19).
The Beverly, Massachusetts-based biotechnology company, which is developing genetic analyzers for rapid pathogen detection, placed the pre-commercial instrument in the Dartmouth-Hitchcock Medical Center’s Laboratory for Clinical Genomics and Advanced Technology at the end of May.
The machine detected numerous positive samples from those tested to date, according to LexaGene CEO Dr Jack Regan.
The LX Analyzer is capable of performing highly multiplex RT-PCR, a gold-standard chemistry that provides exceptional sensitivity and specificity. LexaGene has automated the entire workflow, resulting in less than one minute of hands-on time to initiate sample processing for walk-away testing.
“From the samples tested to date, we have detected numerous positive COVID-19 samples as well as negative samples which are equally important,” Regan told shareholders in a statement.
“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.”
The machine detected COVID-19 positive samples in the hospital study that are more than 25,000-fold different in the amount of detected virus, according to Regan.
“Quickly identifying individuals with such high viral loads is especially important for disease containment,” he added.
LexaGene’s president and co-founder Daryl Rebeck said that developing a tool for pandemic prevention was a key part of the company’s vision when it was founded 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,” Rebeck added.
LexaGene also said it had amended its submitted plan to the US Food and Drug Administration (FDA) for its bid for Emergency Use Authorization for COVID-19 testing after the FDA updated the template for manufacturers with revised requirements. For now, all work using LexaGene instruments is classified as “Research Use Only” which is standard for the industry, the firm said.
The company anticipates further communication from the FDA shortly.
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