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LexaGene Aims for Food Safety, Veterinary Dx Markets with Microfluidic PCR Technology

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NEW YORK (GenomeWeb) – In an attempt to establish a foothold in the food safety and veterinary diagnostics markets, startup LexaGene is developing a microfluidic PCR technology that aims to change the way organizations diagnose and prevent pathogens in these multi-billion dollar industries.

According to LexaGene CEO Jack Regan, the product will stand out from the competition because it can produce pathogen results in sixty minutes or less and will allow end users to develop their own pathogen panels. Based out of Beverly, Massachusetts with offices in Vancouver, the biotechnology company aims to have its technology in the hands of beta testers by next summer.     

LexaGene's technology comprises single-use disposable microfluidic cartridges to concentrate and purify genetic material from samples and a dedicated instrument to perform a molecular analysis on the samples.

Regan developed a predecessor instrument designed for bio-warfare surveillance as a scientist at Bio-Rad Laboratories. Founding his own company, Regan modified the technology so that it could have a robust frame for fieldwork and produce more accurate results.

The instrument detects the presence of pathogens by initially assembling a series of 12 aqueous slugs, one for a negative control, and 11 for targeting pathogens of interest. The control allows the user to confirm that no contamination occurs during the process.

The instrument then carries slugs through a system of microfluidics in an oil stream. The fluid passes through a slug that contains elements that helps break down cell walls and viruses, exposing genetic material.

In an interview, Regan said the technology was designed to help detect pathogens in water-based solutions.

"If you can imagine, you have these slugs in a river of oil, and for 11 of 12, we end up inserting the DNA/RNA into a master mix (a primer-probe mixture) that contains Taq-polymerase, DNTPS, and RNTPs, which are like molecular building blocks," Regan explained.  

By binding the broken strands of DNA and RNA to silica beads and Taq-polymerase, the system produces a complete PCR reaction and identifies pathogens in the liquid sample.

Regan said that while the system examines liquid samples for common pathogens, it can also detect traces of DNA associated with antibiotic resistance. Multiple drug-resistant bacteria (MDRB) have disrupted parts of the food industry, and a product like LexaGene's could quickly identify, isolate, and prevent the disease from reaching the consumer.  

According to Regan, LexaGene's technology distinguishes itself from competitors through three crucial elements. Firstly, it will be built on an open-access platform. Although LexaGene will sell validated pathogen panels to customers, it will also allow end users to buy blank cartridges where they can put in their own real-time PCR assays and analyze samples for any pathogen of interest. Other companies only allow the user to examine specific pathogens. While the instrument has the ability to assemble 12 reactions, it is flexible.

"This is extremely valuable, as not everyone wants to screen one sample for 12 targets; some only want to screen seven targets, and they can instruct the instrument to assemble the amounts they need," said Regan.

LexaGene's technology will also be easy to use in the field, the company said. Most other products require users to add buffers or prime a sample via pipetting to run the PCR reaction. LexaGene's technology, on the other hand, cuts down on the work done by the user, allowing even a layperson to perform the test with minimal instruction. The user collects the sample, loads it into the cartridge, adds the cartridge into instrument, and tests it immediately without the manual transfer of pipette fluid in a different part of the machine.

Most importantly, LexaGene's technology will provide food safety companies a quicker and more efficient alternative to current methods. LexaGene's machine allows for a relatively quick turnaround time, producing results in less than an hour. Current food safety methods, where researchers place a sample into an enrichment culture to detect pathogens, return results in one to three days, costing food packaging companies precious time and money.

Initial Markets

Regan envisions the technology will impact two major markets: the ready-to-eat market and veterinary diagnostics.

LexaGene wants to provide food packaging plants with a guarantee of risk. At factories, where the risk of spoilage skyrockets due to contamination, workers could personally assess the cleanliness of products using LexaGene technology. LexaGene's machine uses "flow-through" technology, meaning it can measure high volumes of fluid in the span of an hour. Smart fluidics concentrate pathogens in samples up to 50 milliliters in volume, thereby minimizing the chances that the subsampling causes a false negative result.

LexaGene also plans to get involved with veterinary diagnostics. Compared to other molecular testing technologies, LexaGene's open-access feature will enable veterinarians to test for what they are interested in at an affordable price.

Regan anticipates partnerships with dairy companies, especially for dairy cows. He believes the technology will save a company's investments and minimize losses due to pathogen infection. The machines could figure out if an animal is sick, as well as diagnose the specific infection.  

"The ability to produce large quantities of milk diminishes if a cow is sick. The dairy company then wastes time and money to improve the cow's health if they detect the disease too late in the game," he said.

"If a farmer, on-site in the barn, can detect the pathogen using our machine, they can take care of the problem quickly and efficiently, so that the disease doesn't spread and ruin the entire means of production."

LexaGene's microfluidic technology could ensure whether early-stage dairy products contain pathogens or are clear for the market, saving companies money, time, and potential recalls.

While the company closed a private placement earlier this year, it plans to seek a second round of financing come November, which will fund the biotech startup through commercialization for 2018.

Once the technology hits beta testing next summer, LexaGene will send it to potential customers, create cost estimates, listen to beta testers' (including farmers) feedback, and make final modifications to the product with a goal of full commercialization by the end of 2018.       

On the horizon, LexaGene foresees its technology utilized in human health diagnostics, but the company does not plan to enter the market in the near term due to the multiple financial hurdles and saturation barriers to the industry.

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