Success Story

Livermore Lab and LexaGene’s LX6: A Rapid and Sensitive Pathogen Detection System

The pathogen-detection industry can be broadly divided into those interested in diagnosing sick people or animals and those interested in preventing illness in the first place (food safety and water-quality monitoring).

The current standard is to culture the sample and then run a series of tests to characterize the pathogen(s). Shipping samples to an off-site laboratory for analysis generally takes about three days. This significant delay increases morbidity and mortality for humans and animals; and on the food safety side, it puts consumers at risk, as often incompletely screened samples are sent out for consumption. These industries need an easy-to-use pathogen detection system that can be placed at the point of sample collection and returns results in just one hour. Having this information in a timely manner will enable doctors and veterinarians to better manage the care of their patients, and food safety officers to have more confidence in the safety of the food being delivered to restaurants and grocery stores.

LexaGene, a biotechnology company developing an automated pathogen-detection system called LX6, is working to address the needs of these markets. Its LX6 technology is capable of processing 6 samples at a time, screens samples for 22 pathogens at once, and returns results in just 1 hour. To operate the instrument, an end-user simply loads a sample and cartridge onto the instrument and initiates sample processing using a touch-screen monitor. Samples are drawn into a disposable microfluidic cartridge, where pathogens are captured, lysed, and their genetic material purified. This purified genetic material is then assembled into a series of reactions to look for different pathogens and antibiotic-resistance factors.

LexaGene CEO Dr. Jack Regan sees the LX6 technology being used in major markets, namely: human clinical diagnostics, food safety, veterinary diagnostics, water safety, aquaculture crop monitoring, and surveillance.

In 2015, the technology was transferred to Bionomics Diagnostics, which was founded by Dr. Jack Regan, the inventor, who worked at Lawrence Livermore National Laboratory (LLNL) between 2006 and 2008, and the president of Bionomics. Bionomics then executed a reverse takeover of a publicly traded company, which now operates under the name LexaGene. Dr. Regan is LexaGene’s CEO and Daryl Rebeck is the company’s president.

The partnership was initiated by a Mutual Nondisclosure Agreement (NDA) between Lawrence Livermore National Security, LLC (LLNS), led by Business Development Executive Genaro Mempin, and BDI. The NDA became effective February 4, 2015.

The goal of LLNS is the commercialization of technology developed by LLNL for the benefit of the U.S. economy. In 2015, Genaro Mempin received a serious statement of interest in the technology. As stated in its commercialization plan, BDI's goal was to develop a fully automated, sample-in/answer-out microfluidic instrument designed to 1) quickly and accurately detect more than 100 pathogens, 2) determine if any detected pathogens contain drug-resistant genes, 3) process multiple samples at the same time in an asynchronous manner, and 4) return test results within one hour of sample loading. BDI intended this instrument to be used in clinical diagnostic laboratories and near-patient hospital settings, such as emergency rooms, intensive care units, surgical wards, and other areas where short turnaround times for diagnostic assays are crucial. The diagnostic information would enable physicians to manage patient care effectively and reduce the spread of hospital-acquired infections.

The excellence in this technology transfer effort can be attributed to persistence, teamwork, and customer responsiveness. Through them, the overall LexaGene technology transfer effort took nearly a decade to complete. Even after Dr. Regan left LLNL in 2008, Mempin’s persistence in keeping the pathogen-detection system as an LLNL invention ready for commercialization kept it on the radar among technology scouts.

After seven years, an investor was finally obtained. Once a commercial interest was identified, the teamwork of the inventor and the technology-transfer officer to provide the necessary technical and business information to the interested party was essential to the technology transfer effort. Although Dr. Regan was no longer an LLNL employee, his availability and dedication to the technology-transfer process was essential to its success.

Images courtesy of LLNL.

Livermore’s mission is to strengthen U.S. security in regard to conventional warfare, cybersecurity, and natural and bio-engineered threats. For the latter, LLNL started working on bio-threat detection before 2001, when bioterrorists sent anthrax-laced letters to Congress and news outlets. After the attacks, approximately $20M in government funding was funneled into LLNL to improve the nation’s ability to rapidly detect a bio-terrorist attack.

The culmination of this work was the successful development of the Autonomous Pathogen Detection System (APDS), for which Dr. Regan was the lead scientist and helped publish the results of that work. The Department of Homeland Security (DHS) adopted the technology in its BioWatch program, where it operated as part of DHS’s rapid-response network.

Dr. Regan’s inventions represent a significant improvement over the APDS system: His new technology has greater sensitivity, specificity, sample-processing speed, breath of pathogen detection, and robustness. The technology is now being commercialized by LexaGene for many different markets that are in need of better technologies, namely human and veterinary diagnostics, water quality testing, and food safety.

Given LexaGene’s LX6 automated pathogen-detection system’s ability to profoundly impact the health and wellbeing of many patients, the technology was nominated for a 2019 FLC Award for Excellence in Technology Transfer. LexaGene’s LX2™ Genetic Analyzer was also voted as one of the “10 Most Promising Food and Beverage Solution Providers 2018” by CIOReview for its detection of E.coli in romaine lettuce, which resulted in a widespread multi-state recall and food safety alert from the Centers for Disease Control (CDC) in November 2018.

LexaGene’s automated genetic analyzer is designed to be placed at the site of sample collection in food and beverage processing facilities to provide easy-to-use, rapid and sensitive testing that provides results in about one hour. LexaGene’s technology utilizes a very low-cost consumable, which will enable them to provide genetic testing to the food safety market.

Currently, food processing plants do not use genetics to improve the safety of their food products due to the cost of testing. However, LexaGene’s technology can be provided to food -processing plants at a cost low enough to promote rapid adoption. By utilizing the power (e.g., sensitivity) of genomic-based testing, food safety officers will be more likely to stop the shipment of potentially contaminated food to grocery stores and restaurants, thereby reducing the incidence of foodborne illness and brand damaging recalls.
“We are thrilled to be recognized for our contribution to the future of food safety in developing next-generation testing to help food processors detect harmful pathogens in a timely and actionable way. Our technology is designed to assess the contamination risk of a food product within just 1 hour so that producers can make faster and smarter decisions on handling their products to avoid recalls and deliver the freshest product possible to their customers,” stated LexaGene CEO and founder Dr. Jack Regan. 

LexaGene was chosen for distinction by CIOReview's panel of business leaders, along with its editorial board. In December 2018, the LexaGene technology will be featured in an upcoming issue of CIOReview magazine, which will include the top ten list.