Modern travel has created opportunities in the global economy that people couldn’t have even imagined a century ago. Need to meet with someone halfway around the world? Board a plane and be on their doorstep in a matter of hours.
But the same technology that allows travel to anywhere in less time than it once took for a person to travel to a neighboring town by foot also makes it easy for pathogens once restricted to their own geographic regions to move as freely as their human hosts. From headline-grabbing horrors like Zika and Ebola to quieter but more prevalent ailments like malaria or even influenza, it’s hard not to wonder if the world will end not with fire or flood, but with a sneeze.
Before doctors can fight disease, they have to know what it is they’re dealing with. Enter molecular diagnostics, a field that focuses on looking at illnesses on a molecular level for quicker and more accurate identification—and one strongly represented in Utah.
Among the state’s molecular diagnostic companies is BioFire Diagnostics, which has one of the few emergency use-authorized tests for Ebola approved by the Food and Drug Administration (FDA). The test has been used “quite extensively” in the United States, Western Africa and other affected areas, says Wade Stevenson, senior vice president of sales and marketing for BioFire Diagnostics, and the company is also in conversations with the FDA for an emergency authorization of a test for the Zika virus.
The Zika test would include other ailments with similar symptoms to help doctors target their diagnosis, he says. While Zika is—despite headlines’ suggestions to the contrary—still fairly rare, it’s important for doctors to be at least able to rule it out, Stevenson says.
“A lot of infectious diseases present with very similar if not identical symptoms. How often do you hear ‘flulike symptoms’?” he says. “It allows physicians to more frequently identify what’s making their patients sick. You come back from the Amazon and you’ve got a fever—Zika is just one of a bunch of organisms you really should be worried about. It’s incredibly expensive and time consuming to test for them one by one, and oftentimes physicians forget (one), so by lumping them together, you drastically increase the probability that you will find a correct diagnosis.”
Ebb and flow
Working with exotic, high-profile diseases can help solve a problem that could cause worldwide panic, but also comes with potential economic hazards, Stevenson says. FDA emergency use designations can help get a test on the market faster than through traditional channels, but can be rescinded just as fast, he says, and if a company is built around a product with an emergency use designation that gets rescinded or the outbreak ends, the business could evaporate overnight.
Even for a more diverse company, he says, it’s tough to know how much demand for a product there will be—if a disease is overhyped in the news, there may not be enough actual cases to need as many testing products a company thinks it has to produce, or there could be an explosion of cases and the demand could far outweigh the supply.
Stevenson points to Zika as a potential case where the reported and actual occurrences differ.
“A lot of the desire for Zika testing is driven by the fear of the unknown, and in the next 12, 18, 24 months, we’ll know a lot more and that will cause our understanding to increase and our fear to decrease,” he says. “Or it could be the things we learn could cause our testing to increase, but that doesn’t happen very often.”
For that reason, he says, including Zika on testing panels with other viruses can help mitigate the potential for a boom and then a bust, while still having the means to test for illnesses.
Correctly identifying illnesses quickly in general is important for ensuring the best outcome when a patient comes to a doctor. Molecular diagnostics has better, more efficient capabilities for that than older means of finding diagnoses, says Mark Powelson, CEO of XCR Diagnostics.
“Molecular diagnostics is superior to culture or immunochemistry because you’re looking at actual DNA of infected agent, and when you can look at that and say, ‘Yes, this is definitely flu’ … then you have the ability to take more precise therapy action with that patient than you would previously,” he says.
XCR Diagnostics, a subsidiary of Fluoresentric, is primarily involved with research on influenza and strep. Powelson says while those diseases might not have the headline power of exotic illnesses like Ebola or Zika, they affect millions and cost billions in medical costs and lost wages. But with early intervention, he says, those costs can be mitigated—or avoided altogether. With the flu, over-the-counter medicines like Theraflu can be adequate treatment for the illness, he says.
In addition, he says, non-identifying patient information can be aggregated to track the spread of diseases before they reach epidemic proportions—something he notes could have been useful for recent outbreaks of flu such as Swine Flu and Avian Flu.
Of course, any test is only as good as it is accurate. When developing tests, Stevenson says, one important consideration is whether the test can have an acceptable predictive value.
“No test is perfect—some are better than others, but we do the best we can with the technology we’ve got,” Stevenson says. “Some organisms are trickier to detect than others. Doctors need to understand exactly how much they can or can’t trust a positive, how much they can or can’t trust a negative result for everything they test for.”
Accuracy and ease of use are vital for doctors, physician’s assistants, nurses, lab technicians and other medical professionals involved in the diagnostic process, says Robert D. Jenison, senior vice president of R&D and chief technology officer for Great Basin Scientific.
“Speed and reliability are paramount to patient care, and one way in which those aspects can be measured is in clinical utility,” Jenison says. “We want to make sure all of the tests we offer provide useful information to the lab technician and clinician for the best possible patient treatment, all in an easy-to-use and cost-effective way.”
Great Basin Scientific currently offers tests for illnesses including staph infection and strep, and is developing tests for bordetella and bacterial infections. While the company has done some work on serious global threats like tuberculosis and malaria, its focus is primarily on testing for various viruses and bacteria. Both Great Basin and XCR have also made strides in making machines for analysis more portable for clinicians.
BioFire, Great Basin and XCR are only some of the molecular diagnostics companies putting Utah on the map in the industry. Jenison says he believes the proximity to Utah universities—and the research occurring there—has made fertile ground for a burgeoning molecular diagnostic industry and spurred development among local companies.
“Similar to the way Silicon Valley or Boston have become known for technology and software that in turn drives innovation in the region, Utah has developed a unique focus in the molecular diagnostics space. I believe having a number of these companies in close proximity helps attract talent to the area, and inspires a healthy level of innovation so that customers and patients alike can be even better served in the long run,” he says.
Powelson says he believes the humanitarian effort-friendly facet of the local culture also contributes to the growing industry, as does its penchant for entrepreneurialism. The well-educated population and business-friendly laws help solidify the state as a good place to start or build a molecular diagnostics company, Stevenson says.
“Because we have had the best here, more and more startups are going to start coming here just because our workforce is becoming better and better at biotechnology, and the early companies here are going to be very attractive to other companies,” Stevenson says. “You have that and the business-friendly environment and the well-educated population, I see a very bright future for molecular diagnostics here in Utah. There are a lot of exciting things happening here in Utah.”