By Benjamin Ross
April 25, 2019 | "Companies seem to be working on what they believe the market needs, rather than what the patients actually need," Jonathan O'Halloran, QuantuMDx's Chief Scientific Officer, wrote in a Diagnostics World News commentary in September. "The resulting new technologies are too expensive, time-consuming, and they don’t multiplex — the ability to do lots of different tests on a single sample."
QuantuMDx's solution is a portable molecular diagnostic kit, called Q-POC, that analyzes samples at the point-of-care (POC) and provides results within 30 minutes.
The UK-based diagnostics company is looking to tackle two distinct problems current diagnostics tests encounter. Either the system is simple and unreliable, or it is complex and focused on infrastructure. These issues are magnified in the pharmacy and local clinic, where O'Halloran says most diagnostic tests will be done globally.
"There are a lot of middle-income countries with a high proportion of their population living in rural communities and these countries have a lot of money to spend on advancing healthcare. Technology leaping is one way they can quickly address the healthcare needs of rural communities and we are looking to apply our technology there." O'Halloran said. "In the West, we're looking at a move away from clinics to pharmacies now, to address the burden on primary healthcare and pharmacy-delivered diagnostics, facing the same issues as rural-based healthcare in LMICs. It needs to be safe, quick, cost effective and not pose a risk of infection to the health worker or pharmacist."
The battery-operated, portable device's simplistic operation allows health workers, such as pharmacists and clinicians, without expertise in the lab to diagnose at the point-of-care. The device operator simply loads samples such as blood, urine, and saliva into a cassette, which is then placed into the Q-POC device.
"One of the beauties of this cassette is how we've been able to get the cost down while also applying the things that differentiate the cassette per test," Jonathan Peat, VP of Business Development at QuantuMDx, told Diagnostics World. The cassettes are designed for universal applications, and are not specific to a test. The sample size requirement at 400 micro-liters also ensures accuracy for the test.
"Essentially we can plug and play with those differences, for example analyzing either a microarray or PCR reagent," Peat said. "Now obviously these differ per test, where you might plug in a different reagent if you were testing for [tuberculosis] or HPV."
The simplicity Q-POC offers in sample prep is something O'Halloran says was lacking when he worked in a pathology lab before starting QuantuMDx 11 years ago.
"They were asking me to set up a molecular diagnostic service, and when I was looking into the market it just didn't make any sense," O'Halloran said. "Doing a GeneXpert TB test for instance, where you have to open up the sputum pot to load a sample, risks both test contamination and infection through aerosolizing the sample, is crazy and limits where you can deploy the technology."
If you automate things and maintain the sample in a closed system, you are in a better position to democratize and make a solution available for everyone, as you eliminate the risks, O'Halloran said.
"Most solutions now that say they're [point-of-care] are not true [point-of-care]," he said. "Either they require electricity or can't be run in an environment that’s above 35˚C or too dusty, and so they're not really helping the people who need it most. Billions of people need access to [point-of-care testing] and they're not getting it."
That's where cost comes in, O'Halloran said. Getting the device down to a low cost was crucial for the company if they wanted to ensure it could be used on a global scale. It was also a key pressure point in development.
"You can get a really low-cost device all the way through your R&D, and when you transfer the device to manufacturing they'll say, 'You can't do it that way,'" O'Halloran lamented. "So, a real pain point is this period now, where we are moving to manufacturing. We can certainly understand why all our competitors made an easy decision to release a technology that was more expensive than they had originally hoped for, as the transfer for manufacture is a real issue. We stood firm and are working with manufacturers who have bought into what we are trying to achieve and continue to work with us to achieve the price point targets we have set."
QuantuMDx is currently manufacturing their Q-POC device with the hope of acquiring CE mark approval Q1 2020. The initial focus has been on HPV, with clinical trials currently being conducted in South America. O'Halloran is excited for the time when the device can make an impact in real clinics.
"I'm looking forward to that first clinic where we can really impact change," he said. "Providing the ability to screen and then treat their patients will really demonstrate the impact of diagnostic technologies."