The LX6 is an automated pathogen detection platform that is open-access to allow end-users to target any pathogen as they can load their own real-time PCR assays onto the instrument.
End-users will need to collect a sample, load it onto the instrument with a sample preparation cartridge and press ‘go’. The instrument will process six samples at a time and return results in about one hour [see a video of how it works].
Beta prototype by August
Dr Jack Regan, Lexagene CEO, said it is in the phase of finalising the alpha prototype.
“We are gearing up to learn from the alpha prototype and make our designer beta prototype, which we will send to prospective customers for testing hopefully in late summer,” he told FoodQualityNews.
“Right now we are in the process of preparing for that, we have this automated instrument but the instrument only does what we ask it to do in the sense that we tell it what pathogens to look for. Over the next several months we are going to be developing reagents for food safety but also veterinary diagnostics.
“Our goal is that when late summer approaches and we are ready to ship out our beta systems to customers that they are fully equipped with all the reagents they need to effectively evaluate the technology and see whether or not it can be of use to them.”
“Once we get to that stage we have to be comfortable that when we deliver a system into the hands of an end user that they will have a positive experience using our technology. This requires a lot of work on optimising the microfluidics of the system and making sure the reagents have been optimised for detection.”
Regan said the process is one of continuous improvement.
“Beta testing is not the end point, we will continue to improve upon the product until it gets to being commercial and even after. There is always room for increasing the ability to detect pathogens because of the different strains or subtypes and you want to make sure you are detecting as much as possible,” he said.
“This is not a next generation sequencing instrument where you are sequencing everything that is there, this is targeted detection. The advantages of targeted detection are that it can be provided at lower cost and is more rapid but the process of targeting the pathogens of interest and adding new assays to detect these new strains or subtypes is something that takes time.
“We had to make a decision on how many samples it can run at a time, we could have gone lower, we could have gone higher. We felt that six was going to be the middle ground where it would be of most use to the majority of customers. The instrument has the capability to detect 22 different targets in a single sample and we think this is sufficiently high to meet the needs of most customers.”
Regan said it will build 15 beta systems which will be sent to veterinary diagnostics, food safety and be for open access.
“We are going to make it open access which means customers can buy this as a tool and load their own assays onto the instrument to do customised genetic testing. That is something that isn’t available on any other automated technology on the market right now,” he said.
“They are all either closed access or so difficult to use that you need to hire a skilled scientist to run it full time. The beta instruments will be put for use to two weeks or so for testing and we expect them to compare to their current standard.”
Company funding and expansion
LexaGene recently signed a lease for a 17,500-square-foot space in Beverly, Massachusetts to support R&D and manufacturing.
The company is installing a level-two biosafety laboratory which will allow it to adhere to biocontainment precautions, specified by the CDC, while testing for pathogens such as E. coli and Staphylococcus.
It previously closed financing of C$5m led by Canaccord Genuity Corp. with PI Financial Corp. and Echelon Wealth Partners Inc.
“We were predominantly running on a shoe string budget early in this company,” said Regan.
“When you are building a product and first getting rolling you have limited funds and we were contracting Boston Engineering to assist us in product development. Since we spoke last April we have closed a C$2m round and we closed a C$5m round in December. It has allowed us to scale up our efforts to bring this product to market.”
Regan said one industry need was ability to offer low cost testing that enables multiplexing.
“If you look at the other detection platforms out there they generally look for one thing. It turns a blind eye to the fact there are other organisms that can cause illness. If you are only looking for one you are being naïve in the sense that it is the only possible organism that could potentially be responsible for a recall and making people sick,” he said.
“Other vendors have had a difficult time providing multiplex-based detection at a low enough cost to be acceptable to food safety. Molecular-based detection doesn’t come for free, it is not a culture based system where you have a plate and it costs $2 to run a test.
“This is something where you are getting a high quality answer in a short timeframe and you have the ability to multiplex. You are looking for 10 or 15 different pathogens, what is the price point where customers are willing to pay for a broader spectrum test?”
Variety of industry reactions
Lexagene said some people are excited about molecular testing in manufacturing plants and others are sceptical based on a survey via Food Quality and Safety and industry conferences.
“Before we pursued food safety we wanted to do a deeper market assignment. We devised a survey, Food Quality and Safety disseminated that questionnaire and we got a lot of responses and we were uplifted by the data,” said Regan.
“We had 70-80 respondents but of those at least a third were enthusiastic and excited to get this technology in-house and to us that was a positive sign. It suggests there is a strong demand for faster molecular testing so that customers can make quicker decisions on how to handle the food they are preparing for sale.
“This reinvigorated us because some people are very traditional, they are set in their ways and don’t want to adopt new technologies. But there are many companies that recognise PCR based testing is extremely sensitive and the ability of PCR to effectively do risk assessment is an extremely valuable attribute and with that risk assessment they believe they can make their own decisions with higher confidence.
“The ultimate goal is to help companies save money and increase profit margins. Because the consequences of recalls are so high we think a lot of companies are willing to pay more to have a better surveillance programme and this in many ways is an insurance policy against a recall.”