Accelerating Point-of-Care Diagnostics

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HO-JUN SUK: Hi, my name is Ho-Jun. I am one of the Co-founders and the CEO of a company called DxLab, where we're developing novel point-of-care testing solutions to bring rapid and accurate testing to wherever there is a need. So my MIT connection starts with my PhD work at MIT that started in 2013. So I started my PhD here in the program called Health, Sciences, and Technology, or HST. During my PhD work here, I actually focused on working on developing new medical devices for treating Alzheimer's disease. So my research was mainly focused on using a novel medical device to come up with a novel treatment option for Alzheimer's disease.

So after I graduated with that work during my PhD in 2019, I continued my postdoc work working on that medical device and started a clinical trial in 2020 with Alzheimer's patients here working with great colleagues here at MIT. But in 2020, as we all know, COVID started. And when COVID started, our clinical trial stopped. So at that point I had-- for the first time in my life-- I had a chance to look back at what I have been doing and also what I want to do for the rest of my life. And I started looking at what was causing the issues that I was seeing-- not just for myself but around the world-- which was COVID at that time. So I started doing some research into COVID, but I realized that there was a huge gap in the testing landscape, not only for COVID but also for all the other infectious diseases that we have had before and that we expect will happen in the future.

After we started the company about two years ago, we really focused on building a platform technology that is really flexible and that can be used to detect virtually any nucleic acid that we're interested in because we saw that that's the core capability we need to be able to apply our technology for various targets and infectious diseases that we want to be able to detect at the point of care with rapid speed and accuracy. So when we started the company two years ago, we really focused on core chemistry optimizations and device development that would allow us to make very flexible technology that would allow us to really-- once we have the platform technology built out, we can quickly adapt it for different applications.

And one of the first applications after we developed the core technology was COVID testing. And we were able to quickly adapt our technology to be able to detect the RNA that's present inside the virus that causes COVID-19. And we were able to show that our technology can rapidly detect those target RNAs in the COVID virus. And we have been able to generate all the validation data that were required to get the FDA'S clearance. And we were lucky enough to actually achieve that FDA clearance through their emergency use authorization process last year in 2022. So that was a great achievement but also a validation of our effort that we actually have been able to build a platform technology that can be applied to a real-world problem. And we're very excited to now do the same thing and now apply it to other major problems and pathogens that are out there to be able to also bring the capabilities that we have to those applications.

So this is our core technology, or platform technology. We call it the DxHub, but internally we call it the toaster because it's the size and the weight of a toaster. Some people call it the panini press, but either way, the key point here is that we developed this portable, small form factor, point-of-care testing platform that you can take anywhere to run the LAMP assay on it and be able to detect the DNA or RNA of interest to be able to use this for very rapid and accurate pathogen detection and infectious disease detection.

The unique feature that we added onto this DxHub platform is what we call the random access test bays. So we have these eight test bays that are numbered 1 through 8, and these test bays are independently controllable, meaning we can use all of these test bays to run up to eight samples or run up to eight test in either a staggered manner or in parallel fashion. That opens up a wide range of use cases unlike other point-of-care testing solutions that are out there. This DxHub platform can be used to run up to eight samples or test up to eight samples for one test type. You can also use this to test one sample for eight different test types or you can do anything in between, where you can run the first patient sample for first test type and the first test, second sample for the second test type in the second test bay, and so forth.

So essentially you can imagine this DxHub instrument is bringing the capabilities that you now only have at the centralized lab-- fully equipped centralized lab-- and we have essentially compressed all of those capabilities into this small toaster form factor and bringing the capabilities that only the centralized fully equipped laboratories have to the point of care.

Our main goals for the upcoming year or two are really to expand the capabilities that we have with our platform technology. And what I mean by that is we really want to now apply our platform technology to other diseases and pathogens that are of interest that can especially be treated effectively or controlled more effectively with a point-of-care testing solution like ours. So we are extremely excited to now apply our testing technology to other diseases that really need point-of-care testing solution. For example, sexually transmitted infections is one of the main areas that we're really interested in, but we're also interested in non-human detection of pathogens-- so non-human pathogen detection. For example, food safety testing is another area that we are really excited in going into and exploring if our testing solution can be a benefit to the key stakeholders who need to worry about and who need to control food safety and pathogens that cause harm to food safety. So over the next two years, we really want to explore those other opportunities and apply our testing solution to really show that we can indeed make a big difference in those areas that need effective point-of-care testing solutions.

One thing that I want to mention-- I know so far I have been focusing on the need for our testing solution because of all the infectious diseases that are out there, but one thing-- There are two more things I want to mention. One is the fact that the reason why our testing solution can be attractive or useful is also the shift that we have been seeing in healthcare. In healthcare, we have been seeing this seismic shift from where we're seeing the healthcare going from facilities to homes. That shift has been happening before COVID, but COVID really accelerated that shift and we expect that shift to continue to happen. So there are many people who think more than hundreds of billions of dollars worth of healthcare will shift to home from facilities like hospitals or urgent cares to people's homes by 2027 or 2028. So we already have a lot of healthcare-related services that have been or that are being optimized for home-based healthcare.

Unfortunately, diagnostic testing, I believe, is not really there yet because we're relying on the current diagnostic testing solutions. The point-of-care at-home testing solutions we currently have, they're mostly only for screening testing but not necessarily for accurate diagnostic testing. For testing that you really need from a healthcare point of view-- to be able to use that data to prescribe a treatment or different follow-on healthcare treatments-- you really need a very accurate PCR-quality testing solution. So that's why even though we are seeing this shift in home healthcare, for someone to be able to really give you a actionable item based on the testing result, the healthcare providers are still having the patients collect their samples at home but still send them to the testing lab to do the testing. So that testing is still stuck in the third-party centralized lab.

What we think we can do there is we can bring-- with our testing solution-- we can give the healthcare providers the ability to essentially bring the capabilities of a centralized lab with them when they go and visit their patients for home-based healthcare. So instead of having to collect their samples and only sending it out to a third-party lab to get the results a few days later, you can run the test on the spot with PCR-quality, diagnostic-quality level testing and do the other follow-on or carry out other follow-on actions that you can confidently follow on because you can trust the data that you get with our testing solution.

Another area that I wanted to mention that we haven't touched upon was veterinary diagnostic, or animal testing. That's also a very interesting area where there's a lot of testing going on. But we're really excited about especially the pet diagnostic area. That's an area where the infectious diseases are really, really overlooked to say the least. People care a lot about cancers or other malignant diseases that pets get but infectious diseases are not really looked at very often or very carefully, but they can cause a lot of havoc just like they do in humans too. And as I mentioned before, if we don't treat those infectious diseases in pets, you never know what's going to happen if they actually can jump into humans like how COVID happened and the monkeypox happened.

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