LexaGene Holdings Inc (CVE:LXG) (OTCMKTS:LXXGF) said Wednesday that it is accelerating the submission of its LX Analyzer to the US Food and Drug Administration as the coronavirus (COVID-19) outbreak expands.
In response so far, the FDA has encouraged labs and manufacturers to submit applications for Emergency Use Authorization (EUA) to help address the lack of quality diagnostics to fight this disease.
LexaGene said the FDA’s track record of granting EUA during declared emergencies, such as the Ebola and Zika outbreaks, provides the company's management confidence that its decision to pursue EUA is in the best interest of its shareholders, its future customers and the patients they serve.
Due to the overwhelming interest in LexaGene’s rapid, on-site analyzer for the detection of novel infectious diseases like COVID-19, LexaGene said it “is taking every measure to accelerate” its FDA-EUA submission.
“The rapid spread of the novel disease COVID-19, with infections reported in more than 90 countries and 37 US states, highlights the failure of existing diagnostics to contain a novel pathogen successfully," said CEO Dr Jack Regan in a statement.
“To contribute to the solution for this outbreak and make us better prepared for the next outbreak, LexaGene is now aggressively pursuing the clinical diagnostics market. We also have the personnel in place to remain on track to penetrate veterinary diagnostics, food safety and other markets that require open-access testing.”
Since the coronavirus outbreak, LexaGene has not only performed in-house testing on its LX Analyzer using the CDC’s coronavirus test, but the company is also developing robust tests of its own for SARS-CoV-2, the pathogen that causes COVID-19, as well as tests for influenza A & B, human metapneumovirus, RSV, and human adenovirus, as a start for a syndromic respiratory panel.
LexaGene said it is talking to several groups about placing one of its beta instruments in the field for research coronavirus testing. The company plans to submit its own COVID-19 test to the FDA for EUA to be run on the LX Analyzer.
Over the last several months, LexaGene has made significant enhancements to the LX Analyzer, resulting in advanced performance while reducing manufacturing costs for improved margins of the commercial unit.
The company has begun manufacturing some of the more complicated components of the instrument, such as its optical module, and made several improvements to the analyzer’s design, including:
- Design work for improved manufacturing and serviceability;
- 30% reduction in size for an upgraded optical module;
- 40% reduction in manufacturing costs for improved unit pricing;
- 15-fold improvement in sensitivity due to a new sample prep cartridge (from initial data);
- A new fluidic configuration that reduces the number of pumps and valves by half;
- Progress towards developing software to improve system usability;
Furthermore, the company has recently contracted an internationally renowned industrial design firm, Ximedica, to accelerate its commercialization efforts.
LexaGene also is in the final stages of hiring key positions in sales, product marketing, quality, regulatory affairs, engineering, and application support. The company expects to announce some of these hires in the near future.
“LexaGene’s progress has been tremendous. We’re doing each step of development properly and we are on track to deliver a next-generation pathogen detection system in Q3 of this year,” said LexaGene President and co-Founder Daryl Rebeck.
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