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Facible Biodiagnostics | Steven Burden, CEO


Clementine Gibard Bohachek

Clementine Gibard Bohachek

CSO, Facible BioDiagnostics
Steven Burden

Steven Burden

CEO, Facible BioDiagnostics
Read Biography
Facible Biodiagnostics is leading the diagnostic testing revolution through our mission to provide hospital-grade diagnostic tests to everyone, everywhere.


My name is Steven burden. I'm the founder and CEO of Facible Bio Diagnostics. The reason I started Facible was to make hospital grade diagnostics available to everyone regardless of their socioeconomic status or where they live in the world. And this really is that people can better measure and understand their own health wherever they want to whenever they want. This motivation that's more of a passion really started over a decade ago is I worked in the labs as a medical technologist. I worked in a large reference lab, small rural hospital labs for several years. And it was in these small rural hospital labs that I saw the reality for many rural Americans. And that reality of actually for many Americans is that they lack access to quality and timely diagnostics. This point was cemented. Around the same time when my mom was diagnosed with a urinary tract infection. It was a pretty nasty infection, where it's been a lot of time and a lot of pain, and for a lot longer than she should have. And ultimately, we come to find out she was given the wrong antibiotics. The reason she was given the wrong antibiotics was because there's no tests that can rapidly identify which bacteria is causing the infection and which antibiotics are actually needed to treat it. So this was the push I needed to go search for a better way to do diagnostic testing. Since then, I've spent nearly a decade trying to solve some of these problems that I experienced as a medical technologist. During my PhD, I found a new and exciting technology, and I focused on starting the next revolution. And it actually gave my PhD around this. So it's a pretty exciting time. The crux of the problem that I set out to solve was that current diagnostics, current diagnostic ecosystems must make a trade off between speed, accuracy, and ease of use. Thanks to the SARS cov two pandemic, we've all become far too familiar with limitations of these current diagnostic technologies. For example, PCR, it's a great diagnostic tool, don't let anyone tell you otherwise. It's fat. Sorry, it's not fast, it's accurate. It's sensitive, but it's complex. It must be run a lab but trained professionals and can take hours to get results. In fact, many of you men here may have actually experienced this beginning the pandemic. turnaround times or wait times for PCR results were 10 to 14 days. That's absurd. That's that's longer than the quarantine period is for the virus. This is the standard of care. Even today, in rural communities, you can still wait two to three days to get your results for PCR. Another example of what I call the trade off problem are these rapid antigen tests. These tests notoriously sacrifice sensitivity for speed and ease of use. In fact, you can take two of these same rapid engine tests right in a row and have completely opposite answers. Again, this is the standard of care. So just put a little more clearly, the problem that I sought to solve was fast tests aren't accurate enough. And accurate tests still are not fast enough or easy enough to use. This is because over the last 25 years, there have only been incremental improvements on these legacy technologies and their limitations, they still remain the same today. Facible solution to the trade off problem is a revolutionary cue that technology, which utilizes DNA transistor Tech was right DNA transistors that find the center of speed, accuracy, and ease of use. So I just want to stop a little bit and talk about how we we Facible got here at the beginning of the pandemic, the National Institute of Health started the RAD X program. The RAD X program was designed to bring new and existing technologies to the market at a scale has never been seen before. Since the beginning of 2020. We've been a participant in this program, and we continue to work with the NIH and now the FDA to get our first test authorized an emergency use authorization. To date, our technology has performed very well in our clinical trials, we've demonstrated a sensitivity of 97%. This is over the full range of PCR, not just the shortened section like many of the antigen tests take with 100% specificity. Our limit of detection is as good as PCR which is much better than the lateral flow tests out there. And for comparison, that's as good as the best Eliza technologies. But my favorite data point is that we have a five minute read time. So in five minutes, we can determine whether there's a presence of a minut quantity of virus within a sample without sacrificing speed. So this data right here has been submitted to the FDA. We're working with them like I said to get our first test authorized and right now Our test lives in a lab. And we want to take it out of the lab to make it available to people where they actually need it the most. Right now we're working on expanding our current respiratory offering to six total pathogens, all in the same test chip. With a five minute read time, done outside of the lab at the point of care without sacrificing the accuracy we've demonstrated today. What really gets me excited, though, is what we're working on now after this respiratory panel tomorrow with Chief Science Officer Clementine Bohachek as she'll be talking about that panel in more detail. So go check her out. Blink said, what gets me excited is this urinary tract infection panel that we're working on. The first deployment of this technology will be the rapid identification of nine or more urinary tract infection pathogens in urine. That's pretty big. But where it becomes really game, changing where it becomes really revolutionary, is when we're able to add in these antimicrobial resistant markers. So after the five minute identification window shortly after, we'll be able to tell you which the most commonly used antibiotics are actually the most appropriate to treat with. This will all be done at the point of care. Further down the line wide In addition, biomarkers for earlier infection detection. This is the test this test right here. This is the one that I wished my mom had when she needed it so many years ago, in fact, still needs it today. This problem has not yet been solved. So many of you sit here and think hey, this could be applicable to many areas inside the human health marketplace. And you're right. But one thing about the culet technology is that it's widely adaptable to areas outside of human health. This allows us to address some of the world's more pressing issues, you think water quality testing, food quality testing, or even horse herpes. There is a need for all these diagnostics today in the markets. So when considering animal health, human health, environmental health, plant health and nutraceuticals, this becomes a very large market very quick. It's estimated to be over $400 billion a year worldwide. Now, because we focused on that human health market, which is much smaller, but still very large. In 2019, this was estimated to be $60 billion COVID came in and just blew it out of the water. It's much, much larger today. For urinary tract infections every year in the US there are over 10 and a half million outpatient visits a year for uncomplicated urinary tract infections. It's estimated that nearly one half of those will receive inappropriate antibiotic treatments just like my mom did. In my personal experience work in the labs. Many of these visits take place in emergency departments. And these tie up valuable community resources. So not only can Facible results improve individual diagnostics, but now we can start to address community results as well and improve those. So, to build these products, we need to continue to raise capital, we're going to raise our Series A utilizing a Regulation A plus pathway. The use of these funds will be to take our tests out of the lab, bring it to where people need it the most and the point of care sitting settings. It'll be used to expand our offerings from one respiratory pathogen to six total respiratory pathogens and the urinary tract infection panels. And it'll be done. It'll also be used to build an analyzer that'll be the backbone for an ecosystem of tests. Or in other words, we want one analyzer that can read all of our key lab tests. It's portable and easy to use for everyone. So I just want to point out if we had taken one of our Q lab tests at the beginning of this presentation, you will have already had your results in your hands by the time I finish, which is now so thank you for your time.



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