Accelerating Point-of-Care Diagnostics

STEX25 Startup:
January 20, 2023 - January 19, 2024

DxLab delivers lab-quality detection of infectious diseases and harmful pathogens in a toaster-size box.

By: Eric Bender

As we know all too well, people with COVID-19 can be highly contagious even without showing any symptoms, and the virus quickly becomes much more difficult to manage if left undetected. “That's why we really need to detect such infectious diseases early,” says Ho-Jun Suk, cofounder and chief executive officer of DxLab, an STEX25 startup. 

DxLab has created a platform for delivering point-of-care diagnostics for infectious diseases. Its first product is a toaster-size test system authorized by the Food & Drug Administration for identifying COVID-19—with accuracy similar to that of lab-based PCR tests, but in minutes rather than days. 

The company plans to expand its platform to other infectious diseases for humans and animals, and to explore other uses such as food safety. Suk is actively seeking industrial partnerships to develop, distribute and/or manufacture the DxLab diagnostic platform. 

Lighting LAMP for disease detection 

COVID-19, unfortunately, gave a perfect demonstration of the need for testing that was both rapid and highly accurate—and the lack of tools to deliver both speed and accuracy. 

“On one end of the spectrum, we have point-of-care testing solutions that are rapid and compact, but they are relatively inaccurate,” Suk says. “On the other end of the spectrum, we have lab-based PCR tests, which are much more accurate and capable of testing multiple samples at once. But they are much slower, bulky and not really fit for point-of-care testing.” 

In 2020 as COVID-19 raged across the globe, Suk joined with Fahim Farzadfard, Louis Kang, and Oz Wassie (all of whom had worked in the lab of Ed Boyden, MIT professor of brain and cognitive sciences) to take on this diagnostic challenge. They turned to a robust and proven technique called loop mediated isothermal amplification (LAMP). 

Like PCR, LAMP is designed to exponentially amplify tiny amounts of RNA or DNA (for instance, RNA found in the COVID-19 virus) in a sample into a sufficient number to be identified, says Suk. 

Unlike PCR, which requires rapid changes in temperatures to do its work, LAMP operates at a single temperature, which makes it possible to use simpler and less expensive tools to perform LAMP. Importantly, LAMP also does its work faster, speeding the detection of disease. 

In addition, “LAMP is highly specific, meaning that we can have more confidence that what we're detecting is actually what we wanted to detect,” says Suk.

LAMP is highly specific, meaning that we can have more confidence that what we're detecting is actually what we wanted to detect

Moreover, LAMP is more robust against compounds in samples that can inhibit standard PCR and muddy results. “With LAMP, we can simplify or sometimes even forego some of the complicated sample purification and processing steps that PCR requires but still achieve similar or better levels of accuracy and faster speed,” he says. 

So with all these advantages, why has LAMP not been more widely employed? 

Invented in the 1980s, PCR had already become the gold standard when LAMP appeared in 2000, Suk explains. The critical need for rapid point-of-care testing for infectious diseases wasn't obvious until COVID-19 struck. “We were accustomed to collecting the samples and sending them to a centralized lab and waiting for two to three days,” he said. COVID-19 showed the global human cost of that delay. 

Going after COVID-19 

Launching DxLab in 2020, Suk and his partners focused on developing a platform technology that is highly flexible and can detect virtually any nucleic acid. 

Their immediate target was COVID-19. They closely worked with collaborators to quickly build a point-of-care LAMP testing system with the size and the weight of a small toaster, called the DxHub. 

They tested the “toaster” at nearby medical facilities in Massachusetts flooded with people needing tests, and analyzed close to 500 patient samples. The facilities normally took 12 to 24 hours to get results from their standard testing system. The DxHub gave results in anywhere from 10 to 25 minutes that were equivalent to lab-based PCR findings in terms of sensitivity and specificity, Suk says. 

The validation data from the clinical study, combined with the performance data generated by the DxLab team in-house, led to the Food & Drug Administration’s emergency use authorization to market the DxHub.

Our multiplex, multi-test processing capability really sets us apart

Importantly, the device features eight test bays that are independently controllable in a “random-access” manner. That design can let healthcare workers test multiple patient samples for one test type such as COVID-19, test one patient sample for multiple disease indications, or do anything in between, says Suk. 

While other companies are now beginning to offer non-PCR nucleic acid amplification technologies, “most of the other point-of-care testing solutions that are currently available can only process one sample at a time for one target at a time,” he says. “Our multiplex, multi-test processing capability really sets us apart.” 

Bringing disease detection home 

Suk expects DxLab to benefit from an ongoing “seismic shift” in healthcare toward services that are optimized for delivery at home, where the DxHub will enable healthcare providers to perform highly accurate diagnostic testing on the spot for quick and actionable information. These immediate results will aid in improving the quality of home healthcare and delivering better treatments for patients. For the healthcare providers, it offers the advantage of tests completed under their own control instead of having to rely on third-party laboratories. 

DxLab plans to broaden the range of pathogens to detect, with targets such as sexually transmitted infections and other respiratory infections. 

Suk also sees great opportunities in animal testing, especially in pet diagnostics. “Infectious diseases in pets are really overlooked, although they can cause a lot of havoc just like they do in humans,” he says. 

Food safety testing offers another promising market, because food processors typically send samples to a third-party lab and wait for a few days to get results. “With a point-of-care testing solution like ours, you can really shorten that turnaround time,” Suk says. That will allow processors to boost their operational efficiencies while ensuring safety. 

Based in Somerville, Massachusetts, DxLab is run by people with highly diverse backgrounds and expertise, and the startup is currently fundraising to support its product development and commercialization efforts.  

DxLab’s membership in the STEX25 program has accelerated its search for partnerships to develop its platform for other applications in human diagnostics, animal diagnostics and food processing. 

“We are also eagerly looking for distribution partnerships with companies that have well-established distribution channels, not only in the US but around the world,” Suk says. 

Partnerships with manufacturers also will be key. “We would love to find other great partners who can help us scale up and reduce the cost, so that we can provide our solution at accessible pricing for everyone in the world,” he says.