The first at-home COVID-19 testing system to receive FDA certification enters the market in less than 9 months.

LexaGene is commercializing its pathogen detection system for food safety, water quality, veterinary diagnostics, and viruses such as COVID-19. LexaGene developed the first diagnostic analyzer for points-of-need environments – including clinics, hospitals, and airports. The company’s genetic analyzer can detect new pathogens and other molecular markers in hours instead of days. The biotechnology company selected Boston Engineering to transform its concept into the industry’s first fully automated, open-access pathogen detection platform.

Product development for LexaGene’s quantitative polymerase chain reaction (qPCR) system includes:

• Industrial design and human factors
• Microfluidic concept research and development
• Disposable sample and preparation cartridge development
• Chilled fluid storage, thermal management
• Multi-threaded, parallel software architecture
• Temperature proportional-integral-derivative (PID) controller design
• Thermal simulation, materials analysis
• Alpha prototype development

The full Alpha prototype includes the following features:

• Deliver many test results in approximately one hour, which is exponentially faster than waiting 1-5 days for standard food safety test results
• Provide ease of operation so that users don’t need technical training to run accurate tests
• Accelerate testing by processing multiple samples concurrently while also analyzing each sample for different types of pathogens
• Tailor testing parameters via user-configurable, parameterized scripting and configurable pathogen detection assays
• Support variable sample input volumes to reduce the requirements to run effective tests

The company’s rapid pathogen detection analyzer to test for COVID-19 has been placed at the Dartmouth-Hitchcock Medical Center’s Laboratory for Clinical Genomics and Advanced Technology (CGAT) in Hanover, New Hampshire.  It 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.

“From the samples tested to date, we have detected numerous positive COVID-19 samples as well as negative samples which are equally important,” said Dr. Jack Regan, LexaGene’s founder and CEO.  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.”

Daryl Rebeck, LexaGene’s president and co-founder, states, “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,” said Daryl Rebeck, LexaGene’s president and co-founder.