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https://tinyurl.com/w4g7rr5This New Device’s Rapid Pathogen Identification May Be

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Regis999   Tuesday, 12/10/19 05:22:21 PM
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This New Device’s Rapid Pathogen Identification May Be Our Next Big Medical Breakthrough

Jim Vinoski


I write about all facets of manufacturing.

LexaGene's LX2 Genetic Analyzer

The U.S. is just finishing up an autumn full of scares around the country over the mosquito-borne EEE virus. During the Thanksgiving holiday, we had yet another large-scale lettuce recall. Now flu season is coming into full swing. So our concerns about pathogens – disease-causing organisms – are spiking right now.

What if we had a piece of technology that could quickly detect and identify those nasty little creatures that cause so much heartache, illness and death, allowing fast diagnoses for illness prevention and treatment? LexaGene, a start-up in Beverly, Massachusetts, may have just that.

The company was founded in 2016 and is publicly traded on the TSX Venture Exchange (TSX.V:LXG) and over the counter in the US (OTCQB:LXXGF). In a post-IPO capital round in October, LexaGene raised $5 million. Their parent company, LexaGene Holdings, Inc., has a market capitalization of over $35 million. The company is on the cusp of the commercial launch of its technology.

“First and foremost, it’s important to identify the problem,” said Dr. Jack Regan, LexaGene’s founder and CEO. “Current diagnostics are failing us. We shouldn’t be getting treatment based on the guess of a physician.” That’s no knock on our doctors, who are doing the best with what they have. The problem is that today’s state of the art diagnostic methods are too slow. Current testing involves culturing samples to allow any microorganisms to grow to a quantity large enough to analyze. This can take days to deliver results, and can often still be inexact.

LexaGene says its LX2 Genetic Analyzer is the answer. It delivers exact results in about an hour. “What makes us so fast versus culturing? We directly amplify the genetic material,” explained Regan. “The instrument amplifies bacterial genetic targets roughly one trillion-fold for easy optical detection. Our technology allows for gold standard testing in both performance and speed.” The technology arose out of work Regan did previously at Lawrence Livermore National Laboratory. “It’s the next generation instrument of what I worked on there,” he said. “The government used it for bio-threat detection – anthrax, plague, and smallpox, for example. In contrast, our instrument can be used across many applications, including clinical diagnostics, food safety, and pandemic prevention. The technology automates a very powerful detection chemistry, making complex testing easy. You essentially load a sample with a cartridge, enter a sample ID, and press ‘Go.’”

Of those multiple applications of the technology, the most obvious is disease detection. “We enable rapid diagnostics, giving physicians the ability to determine the best way to treat their patients,” Regan said. That allows for immediate treatment of the known illness.

It can help with current antibiotic challenges. “The CDC [U.S. Centers for Disease Control and Prevention] sees antibiotic resistance as one of the biggest health challenges of our time,” Regan said. “Better diagnoses will eliminate antibiotic overuse. Right now physicians prophylactically prescribe antibiotics, not knowing whether the symptoms are due to an infection or other medical concern, or whether any prescribed drugs are going to be effective. As a result, patients can spend days on an ineffective antibiotic. If the doctor can quickly detect whether an infection is present and whether drug-resistance factors are present, he or she can prescribe the correct treatment right away.” This offers a better avenue to antibiotic stewardship.

Preventing a pandemic of any kind is another opportunity. “Our technology is perfectly suited to this,” said Regan. “We can configure it for rapid detection of different strains.” The flu is an obvious application. “I did my doctoral work on influenza,” he added. “It’s very deadly. Every year about 30,000 people die, but that’s a drop in the bucket compared with a pandemic, where 33 million might die in the first six months.” Each year’s flu shot can be less than effective if it treats for strains other than the most prevalent one. LexaGene can screen for known strains, then add testing for new strains as they appear, potentially allowing for corrections to the vaccine.

“With next generation sequencing, we can identify the pathogen that causes death early on,” Regan said. “We can then get a test out in two or three days that will provide a rapid way to triage and quarantine those affected.”

Food safety is a big potential application as well. There, producers working to prevent foodborne illnesses rely on laboratory testing that can take days to deliver results. LexaGene’s quick pathogen identification can help reduce the potential for contaminated products reaching consumers, and related illnesses and deaths. They can also help food processors avoid costly product recalls. (Here’s one of my related articlesthat goes into greater detail on this.)

When it comes to a breakthrough new diagnostic device, of course, one concern is sure to pop up: how can we be confident this isn’t the next Theranos? “How do we set readers at ease regarding our technology? Look at the founders and the members of our Board,” said Regan. “Theranos had big names with no experience in diagnostics. At LexaGene, I’ve focused on building our scientific integrity, with Board members who have backgrounds in diagnostics, science and industry work. Personally, I have an intensive background in this particular science from my doctoral studies, work at Lawrence Livermore, and experience in successful startups and larger life science companies. Furthermore, I’ve published numerous times and have numerous issued patents. And we have outside companies already using our technology independently. In contrast, Theranos had none of that. One of the other things that frustrated me about Theranos was that their claims were so unrealistic. They said they could run 200 accurate tests from a single drop of blood, but published studies have shown that the chances of detecting a single pathogen in one drop of blood are less than 50% because bacteria don’t grow to high concentrations in the blood. There’s simply no way they could do what they claimed.”

Regan is focused on the positives of his technology. “We’ve completed numerous beta tests at potential customer locations, and which shows investors that the technology works exceptionally well and is now nearly ready for commercial sales,” he said. “Right now, we’re working on hiring a sales team and in discussions with contract manufacturers. The wheels are in motion for us to hit the ground running. We’re addressing a desperate need,” he added. “We’re perfectly poised to make the transition into sales in mid-2020 and we look forward to sharing stories of our technology saving lives. It’s not that far away.”

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