By - August 01, 2023
From digital solutions to artificial intelligence (AI) and medical innovations, laboratory technology plays a key role in the evolution of global health. While the recent pandemic was, in some ways, a trial by fire that necessitated technological breakthroughs in low-resource environments, the growth of AI and machine learning shows that even more laboratory innovations are on the way.
Critical Values spoke with Sally McFall, PhD, Co-Founder and Chief Scientific Officer of Minute Molecular Diagnostics, a spin out of the Northwestern University Center for Innovation in Global Health Technology (CIGHT), and Jonathan Schmitz, MD, PhD, D(ABMM), Co-Director of the Vanderbilt Center for Personalized Microbiology and Director of Translational Microbial Diagnostics at Diagnostic Laboratories, Vanderbilt University Medical Center, about their emerging laboratory technologies that have the potential to truly impact the future of the global health space.
In 2017, Dr. McFall co-founded Minute Molecular Diagnostics (M2Dx) with David Kelso, PhD, Clinical Professor of Biomedical Engineering at Northwestern University, and Kara Palamountain, Research Associate Professor and Lecturer at Kellogg at Northwestern. CIGHT and M2Dx developed a rapid qPCR platform for point-of care settings, which pivoted in 2020 to focus on COVID-19 in response to the pandemic. As a result, they developed the DASH (Diagnostic Analyzer for Specific Hybridization) Analyzer and the DASH/SARS-CoV-2/S test cartridge and received Emergency Use Authorization from the FDA in March 2022.
M2Dx has been scaling up manufacturing of the analyzers and cartridges and will have the capacity of producing 250,000 cartridges a month by August 2023, Dr. McFall says. Once the manufacturing system is running, they’ll begin commercializing the DASH system.
“What stands out to me about rolling out the system is that the actual invention and optimization of the DASH analyzer, cartridge, and tests was easy compared to commercialization of the product and scaling the manufacturing,” Dr. McFall reflects.
The next step is adding new assays to the DASH system.
“We are currently working on a number of new assays, including a FluA/FluB/COVID combo assay, tests for sexually transmitted diseases, and a test for Myocobacterium tuberculosis that uses an oral swab as the specimen,” she says.
Dr. McFall believes the DASH system is going to have a strong impact on global health.
“The DASH platform will play an important role in responding to emerging infectious diseases,” she says. “We can rapidly develop a test for a novel analyte once the sequence is published, and DASH can be quickly deployed to hot spots for testing and surveillance.”
She does have advice for any laboratories wanting to start their own projects impacting global health.
“My advice for developing technology to impact global health is to use approaches that can address issues in both high-resource and low-resource settings,” Dr. McFall says. “The work in high resource settings will help finance the development of the technology.”
As both a clinical microbiologist and an investigator of microbial pathogenesis, Dr. Schmitz describes his role as helping bridge the gap between the two disparate environments.
In the early days of the pandemic, a surge in testing demand coupled with limited supplies and reagents compelled his laboratory to develop creative strategies for molecular testing that could sacrifice some analytic sensitivity without sacrificing diagnostic sensitivity. This allowed them to quickly ramp up local, extensive COVID-19 testing early in the pandemic.
“We’ve continued doing it for both COVID and other pathogens,” Dr. Schmitz says, “asking what’s the strategic shortcut we can take where we can get the same results functionally, even if we’re limited in terms of resources.”
The methods his laboratory developed are also helpful on a global health level, giving laboratories that have fewer resources insight into how they can utilize molecular testing in urgent environments too.
This strategic approach to problem-solving has also extended into a novel biobank that could open the doors to more personalized diagnostics in the future. Dr. Schmitz’s team has sought ways to harness the vast number of specimens already tested in both central diagnostic laboratories and at the point-of-care and allow them to be accessed and studied by research and development laboratories.
“Clinical diagnostic environments generate a wealth of real-world specimens as part of their routine care,” he explains. “But their routine clinical testing may not capture all the information that is potentially valuable from a broader academic perspective, because that wasn’t the original goal for clinical testing. Specimens that were collected for one diagnostic purpose can have many secondary research purposes, especially when information is available on the underlying clinical scenario.”
In fact, these specimens are often simply discarded after testing is complete.
“In most places, many specimens are thrown away when routine diagnostic testing is complete,” he says. “We’re trying figure out how we can leverage these diagnostic specimens and do additional high throughput testing on them. At a global public health level, it could greatly inform us about what’s going on in our population.”
In other words, he says, “it really gets down to bridging the gap: treating one lab’s waste as another lab’s treasure.”
Vanderbilt University Medical Center has been working on bridging this gap.
“MicroVU at Vanderbilt University is a large-scale biobanking program where all the clinical isolates from our diagnostic laboratory, as well as a large number of specimens themselves, get routinely banked,” Dr. Schmitz explains. “They’re banked in a way where the linkage to the underlying patients is maintained, but through a coding that maintains safe harbors, so research is done in a secure, ethical manner.”
This means investigators and researchers can access specific specimens, such as respiratory specimens positive for COVID-19, from particular patient cohorts. Being able to study a large number of samples with detailed clinical characterization can open the door to more personalized diagnostics down the line, as well as basic knowledge on host-pathogen biology.
“When we study the mechanism of host interactions today, it’s always done through a simplified model where you take a model strain and a model host and put them together,” Dr. Schmitz says. “That’s classic science, but it overlooks swaths of diversity on both the human side and the pathogen side.”
One of the goals of this biobanking is to make medicine and diagnosis far more personalized. Among various projects, MicroVU has focused largely on two infections that already generate a massive volume of specimens: COVID-19 and urinary tract infections. While the responsible pathogens are very different, both can range from being asymptomatic to life-threatening, but it’s not always clear why.
“It’s difficult to study because there are so many variables,” Dr. Schmitz says. “But if you have access to a large number of real-world specimens and real-world data points, you can begin to parse that and utilize the diversity.”
New technologies like AI and machine learning can go a long way in helping sort through the diversity faster.
“When you’re trying to figure out which one of five million base pairs might be more associated with one clinical type versus another, you can’t just say, ‘I’ll start with base pair one,” he says. “Having things like machine learning models could parse that out to a level that would take millennia for an individual to do. It’s an exciting time be alive.”
Thanks to the biobanking system being pioneered by MicroVU, more laboratories will have access to these specimens. They’re already getting requests from other academic institutions and companies outside of the Vanderbilt system, and they believe this biobanking will ultimately have implications for improving health on a global scale, through both diagnostics and the sharing of resources.
Dr. Schmitz has advice for other laboratories interested in getting involved, whether by starting their own similar program or partnering with his biobank.
“On a personal level, I’m always happy to speak with folks,” he says. “But in terms of how you’d launch something like this: be organic. What challenges are you trying to address? The higher the volume of clinical specimen you have, the easier it is. That’s why respiratory and urinary testing has been useful. It’s the sort of thing that can develop quickly.”
With machine learning and technological innovations happening at a faster pace than ever, it’s an exciting time to be part of laboratory science. Dr. Schmitz and Dr. McFall’s works are just two examples of how these technological advancements are changing health care both locally and globally.