We live in interesting times, bearing witness to the convergence of new accelerated healthcare technologies that empower patients to manage their own personal health. Innovations like personal blood glucose meters, home pregnancy tests, and other point-of-care diagnostic devices. And now, thanks to an Ottawa-based firm, Spartan Bioscience, the field of DNA analysis is set to take an exponential leap into the future.
The promise lies in the company’s invention of a tiny new device called the Spartan Cube. As Paul Lem, CEO and founder of the Spartan Bioscience explains, the Spartan Cube is taking the power of DNA analysis farther, faster and closer to the end user than ever before. Billed as the world’s smallest DNA analyzer, with the Cube Lem and his team have constructed a device that not only shrinks the DNA testing process, it takes it out of the hands of lab technicians working with large machines and puts it into those of the consumer. At the same time, it has cut back on the time it takes to produce DNA analysis results– from weeks and months, to as few as 30 minutes.
“It’s small, roughly the size of a coffee cup, and it packs a powerful punch to accurately diagnose a range of infections,” he says. He adds that the device has all of the D’s of exponential technology covered. For example, it’s digitized, disruptive, demonetized, and one day, hopefully he says, it will be fully democratized.
“Because it’s small enough to fit into your hand and extremely portable, you can bring it anywhere.” he says.
This evolution of DNA testing is what he envisioned when he first launched Spartan Bioscience in 2005. Back then he was a doctor specializing in medical microbiology. Training to run a diagnostic lab housing mainframe DNA analyzers, he also had a penchant for inventing.
“We’d see many patients in these labs, and I remember what was so frustrating was that we weren’t able to give patients their results right away,” he recalls. He adds that often, patients would have to wait weeks, even months for
their results. He felt that the anxiety of not knowing or waiting on these results must have been excruciating for these patients, and he believed that there had to be a better way to conduct these tests.
“Basically, someone had to figure out a way to take mainframe DNA analyzers out of the lab and bring them to the bedside and I felt that I could be that someone.”
“That was the seed that planted the Spartan Cube idea,” he says.
The decision to change careers and become an entrepreneur/inventor was an easy one he recalls. He adds that transitioning was equally about making more of a difference in the world.
“As a doctor, I realized that I was limited to the number of hours I had in my day and the number of patients that I could see. At most maybe, I could see 10 or 20 patients a day. I thought if I could make products like the Spartan Cube, I could scale well beyond this where potentially, I could reach millions of people with these devices or products.”
And yet, there’s a major difference between using such a device and actually inventing one. Likewise, constructing a complex tool like the Spartan Cube required a unique skill set. For most of his peers, it would have been too difficult to do so, but not for Lem. An avid “tinkerer,” Lem says he had always been fascinated by such healthcare tools and curious about getting to the root of how and why they work.
“I would say throughout my undergrad, and even in high school, where I once won a silver medal at a Canada-wide science fair, I have just loved to play with the tools sometimes even building my own,” he says.
On the path towards “Making a Difference”
According to Lem, everything he has done since leaving medicine has been part of a grand strategy.
“The actual goal is to change the world,” he says.
For Lem, the first significant step on this path was the creation of Spartan’s first generation device, a four-well endpoint PCR instrument called the Spartan DX. This device, after years of tinkering, would evolve into Spartan Bioscience’s first commercial generation Spartan RX platform. The RX, which included a front-end DNA collection
plus DNA extraction components all together in one device, was approved by the FDA in 2013 for one test, identifying patients with a mutation of the CYP2C19 gene.
“This was important from a pharmacogenetics point of view,” Lem says, “as it was used to identify cardiac stent patients that had the mutation and were taking the blood thinner Plavix®.”
The reason that identifying this mutation is important he explains, is it interferes with the efficacy of the drug. Also, if you have the gene, taking the drug can also lead to serious complications. By pre-identifying such patients, cardiologists can instead prescribe other drugs in Plavix’s place ensuring efficacy and safety.
That first-generation device, roughly the size of a toaster, was an impressive first step towards miniaturization, but
Lem knew even back then that he and his team could find a way to make it even smaller and expand on its applications. Several years later, he and his team have achieved that goal.
A Game Changer
Explaining how the Cube works, Lem says it takes all the steps of DNA analysis and puts it into one small sample-to-result box. “It is a PCR-based system that fully integrates DNA extraction, and analysis, with the results shown on an easy-to-use interfaced wireless tablet.”
Lem adds that integrating all these steps makes the device a game changer. The process begins with DNA collection, using a swab that comes with the box. After the user collects the right amount of DNA sample, the swab is then inserted into the box where the DNA extraction is automatic and quick. He adds the cells are broken open through polymerase chain reaction (PCR) and the DNA is released. The machine then uses fluorescence to determine what is present in the DNA.
“There’s a software algorithm that interprets the PCR result and the spits out the actual result that says, for example, whether some-thing like Strep bacteria is there or it isn’t,” he explains.
He expects that the device when approved, will be in every doctor’s office, in pharmacies, and eventually in millions of homes, all at a relatively cheap price.
“With the Cube we’re striving to drive the price of DNA analysis down significantly and make it affordable to everyone,” he adds.
“Three major industry verticals”
Further, as mentioned, the Cube isn’t just for medical applications. Rather, according Lem, because it can do any type of DNA or RNA application, wherever either is present, the device can detect it. This means the device can also even be used for example as a detection tool for certain environmental contaminants.
“The way that we think about who can use the device, is that there are three major industry verticals that we want to go after: infectious disease, pharmacogenetic, and finally food and water safety testing.”
Under these verticals, he says the instrument will have tests that can identify Strep A (which is the cause of strep throat) in DNA; it can determine whether a person carries a certain gene tied to the development of Alzheimer’s; and environmentally, it can be used to monitor ventilation systems for Legionella, a bacteria that when inhaled by humans can cause a potentially fatal type of pneumonia called Legionnaires’disease.
Moreover, on the pharmacogenetics front, the company is focusing on the development of two tests – ApoE and the aforementioned CYP2C19. ApoE (apolipoprotein E) genetic mutations increase the risk of developing Alzheimer’s disease, while CYP2C19 mutations affect how people metabolize drugs. And additionally, for food and water safety,, Lem says the Cube could also be used for detection of other bacteria such as E. Coli, Listeria and Salmonella.
The company also has plans to further expand the testing in the other two verticals as well.
“Our hardware team is always hard at work figuring out how we can eventually approach all diagnosis like the old tricorders on Star Trek,” he says. “You simply insert the sample, press go and away you go.”
Regardless of the vertical, Lem also expects users to come from many different types of industries.
“For the healthcare industry, we’re looking at people who work in hospitals, doctor’s offices and pharmacies. For the food and water testing industry, we’re hoping to get it into the hands of building managers and restaurant owners. The ultimate goal is to get this technology to wherever people want it– even into people’s homes,” he says.
Already the company’s first generation device, the Spartan RX, is selling around the world, giving the company a revenue stream to further develop the Spartan Cube. The RX has been approved by Health Canada, both European and Asian Regulatory Agencies, and most importantly, it has FDA 510(k) approval. Now the company is focused on getting FDA 510 (k) approval for the Cube.
He says that very fortunately, the company has already learned some valuable lessons from the RX approval pathway that should make the process simpler for the Cube.
The company also has a very big player in its corner. Specifically, Spartan has benefited from a partnership with consumer product giant Canon Inc., a world leader in the camera and copier market. Through its U.S. arm, Canon BioMedical is helping Spartan in various ways to both develop and market the Cube worldwide. This partnership has also given Spartan access to advanced manufacturing facilities, specifically that scale of manufacturing that makes it possible for Spartan to execute on its vision.
“They have manufacturing expertise at an enormous scale, as well as a massive global network for sales and service,” says Lem. “They also have decades of consumer electronic design expertise, so they know how to design the user interfaces and how to make things easy to use for the average person.”
They also have a huge fleet of technicians at their disposal to service their device.
“I think they have field technicians that are servicing almost every office building in the world because like Canon photocopiers or printers are in every office building, pharmacy and library. So, they already have all these feet on the street which could prove useful if we get the Cube to where we want it to go.”
According to Lem, prior to this partnership, Canon had been developing its own DNA diagnostics division for years, having a very difficult time making a point-of-care device. They decided to look externally for a more user-ready device.
“The sent their business development people all over the world asking key opinion leaders and top scientists for any up and coming companies, and they kept getting referred back to us, and that’s how they found us,” he says.
Lem says it has meant a lot to have such a major player to lean on, and he expects the two sides now are very close to achieving their mutual goals. Likewise, Lem sees a very bright future for the device and for the future Spartan devices to come
“It’s amazing to think as little as two decades ago, machines like the Cube took up so much space, even filling offices. And here we are today – we’ve built the world’s smallest DNA analyzer and we’re on the verge of making it accessible to millions.”