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LexaGene Continues Vet Dx Market Push, Explores Sequencing Sample Prep for Microfluidic PCR Tech


NEW YORK (GenomeWeb) – Since partnering with several academic groups earlier this year to evaluate its microfluidic PCR platform for pathogen detection in applied markets, LexaGene has potentially found another application for the technology in the form of sample prep for cancer diagnostics.

In addition, having completed a C$5.8 million ($4.4 million) bought deal last week, LexaGene is examining additional potential financing opportunities, including securing non-dilutive grant money, performing a private placement round, starting an additional bought deal funding round, or filing for an IPO on the Nasdaq or New York Stock Exchange.

LexaGene's LX6 platform features single-use microfluidic cartridges to concentrate and purify genetic material from liquid samples. The platform can run 12 reactions at once, produces results in 60 minutes or less, and allows end users to develop their own pathogen panels.

In May, LexaGene announced that it is partnering with Stanford University to use cancer sequencing tools in combination with the firm's microfluidic technology. LexaGene CEO Jack Regan said that the firm will work with Stanford associate professor Hanlee Ji to study whether its technology could be applied to Ji's cancer diagnostic technology, which allows the group to sequence a molecule multiple times without destroying the sample while developing the sequencing library.

"Ji had been searching for a microfluidic platform that has a disposable cartridge, which he plans to integrate with his own research," Regan explained. "He believes that his sequencing technology could be very easily married into our sample prep cartridges."

In order to make the overall process efficient, Ji's team needed to leverage external microfluidic platforms for rapid, automated sample prep. Regan believes that Ji's technology best performs with a removable low-cost cartridge that "interfaces with a fluid delivery system, [which] is a perfect match [for our] technology."

LexaGene has therefore signed a material transfer agreement with Ji's lab, allowing Ji access to components to assemble the firm's cartridges and insert liquid cancer samples. In addition, LexaGene has provided Ji a clamping mechanism to help his team deliver DNA samples and buffers into the cartridge.

According to Regan, Ji's team will create sequencing transcripts inside the cartridge that will be eluted out to use in downstream next-generation sequencing instruments.

"At its core, we've built a microfluidic system, and it happens that there are other uses besides pathogen detection," Regan said. "[Ji's] end goal is to use our system as a way to help the upfront process for next-generation sequencing, to develop sequencing [libraries] that would later run on an Illumina platform."

Earlier this year, LexaGene announced that it is collaborating with Ethos Veterinary Health and Texas A&M to develop assays on the prototype version of the LX6 platform.

As part of its collaboration with LexaGene, Ethos is providing clinically annotated canine urine samples for diagnostic testing. Regan noted that LexaGene had previously worked with Ethos using conventional technologies such as MALDI-TOF mass spectrometry device at the firm's reference laboratory. In addition, Ethos will later serve as a location for beta testing LexaGene's LX6 assay.

"While MALDI-TOF gives identification, it doesn't work with viruses because you can't [examine] them in culture, and it cannot do drug sensitivity testing, and the turnaround time is slow," Regan argued. "After speaking to Ethos, we found that [these factors] are very important to [clinicians], and so we're trying to outcompete MALDI-TOF in that space [by] using our technology to help inform the point-of-care space. "

Meanwhile, LexaGene will run assays on the LX6 prototype on urine samples provided by Texas A&M's Veterinary Medical Diagnostics Laboratory university to search for canine-based pathogens that flourish in different climates. Regan said that the firm's major goal is to evaluate the prototype's diagnostic ability on a variety of pathogens. He estimates that the study will examine anywhere from 100 to 200 canine urine samples.

"As we get closer to beta testing, we will develop a group of collaborators," Regan noted. While he declined to name additional groups, Regan noted that the firm is currently negotiating with several academic and commercial groups as of July.

While unsure of the eventual price of the assay, LexaGene President Daryl Rebeck said the firm will "have a better idea of the price once we get to beta mode, as we're currently generating data on the alpha prototype." He added that the firm's primary focus is to engage the veterinary diagnostic space, while considering US Food and Drug Administration approval down the road.

"We want to show how the instrument works, and if the [customers] are interested, we can build out a customized panel and perform syndromic testing," Rebeck explained. At the same time, "not all people are doing syndromic testing, as they have other needs, such as food safety, [which] include pathogens that cause a suite of troubles."

Regan noted that LexaGene anticipates commercialization and full penetration into US market by the mid- to late 2019.

LexaGene will use the C$5.8 million raised in its recently completed bought deal financing to fund these activities, as Rebeck explained that designing the beta version of the PCR system requires capital to invest in software and other elements. In addition, LexaGene also previously raised C$5.8 million in a funding round in December to push commercialization of the LX6 prototype.

Rebeck also said that LexaGene aims to uplist on the Nasdaq "by end of the year, if not within the first couple of months of 2019, depending on the market conditions."

"While the process of moving from subcontracting to in-house development took a little longer than expected, the technology otherwise has been progressing nicely," Regan said. "Our goal is to expect costs, in terms of plastics and liquid reagents, to be quite low," which the firm argues will allow it to perform high-quality testing at competitively low prices.

Because LexaGene's technology is open-access, Rebeck believes that the beta-testing stage will allow the firm to demonstrate a proof-of-principle for other markets, including food safety and clinical diagnostics. In the past year, LexaGene has added "several pathogens" to its validated list of assays, and the firm aims to present a "compelling dataset" on the prototype in a study "later in the fall."