LexaGene Holdings, Beverly, Mass, has issued a corporate update on the development of its commercial technology in response to the demand for its technology in view of the COVID-19 outbreak.

In response to the COVID-19 outbreak, the World Health Organization has declared a ‘Public Health Emergency of International Concern’ and FDA has encouraged CLIA labs and IVD manufacturers to submit applications for emergency use authorization (EUA) to help address the lack of quality diagnostics to fight this disease. Due to interest in LexaGene’s rapid, onsite analyzer for the detection of novel infectious diseases like COVID-19, LexaGene 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,” says Jack Regan, PhD, founder and chief executive officer of LexaGene. “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.”


Jack Regan, PhD, LexaGene.

Since the coronavirus outbreak, LexaGene has not only performed in-house testing on its LX analyzer using the Centers for Disease Control and Prevention’s coronavirus test, but the company is also developing tests of its own for SARS-CoV-2, the pathogen that causes COVID-19. The company plans to submit its own COVID-19 test to 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 toward developing software to improve system usability.

“LexaGene’s progress has been tremendous,” says Daryl Rebeck, president and cofounder of LexaGene. “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.”

For more information, visit LexaGene.