We all experienced the importance of at-home testing from the Covid19 pandemic and today's guest is helping bring rapid, affordable, and accurate tests to everyone including traditionally underserved areas.
Dive into how Domus Diagnostics got started, the importance of Nucleic Acid Testing, and getting started with clinical trials to get FDA clearance with Kelly and Paul on this episode of From Lab to Launch.
About Paul Chapman
From sales representative to CEO, Board Member and Angel Investor, Paul Chapman has over 25 years of international business leadership experience in Molecular Diagnostics, Point of Care Diagnostics, Medical Devices and Life Sciences. He is skilled at change agent and is a creative, action-oriented leader with a broad base of international Diagnostic, Medical Device and Life Sciences executive experience. Whether creating a new business or optimizing existing business models, Paul has created significant value by focusing on development of a high-performance culture through professional "A+" teams that he helps build.
About Domus Diagnostics
Domus Diagnostics seeks to create tests for infectious diseases that are affordable, user-friendly, accurate, and rapid enough to address the needs raised by current and future public health crises. All this not only in the US but in every global market including underserved areas - talk about a big vision!
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Music by keldez
Hey everyone. I'm Kelly from Qualio and I'm your host here at From Lab to Launch. Thanks for joining the show today. We've now published over 50 interviews with innovators in life sciences around the world. It's been so inspiring to hear the stories of perseverance and innovation to improve human health and save lives. If you've enjoyed the conversations, consider subscribing and giving us a review on Apple or Spotify. And if you want to be on From Lab to Launch, please see the application linked in the show notes. Joining us today from the Boston area, we have Paul Chapman. His career spans from sales representative to now CEO, board member, and angel investor. Paul has over 25 years of international business leadership experience in molecular diagnostics, point of care diagnostics, medical devices, and building life sciences companies. Paul today leads Domus Diagnostics, where his team seeks to create tests for infectious diseases that are affordable, user friendly, accurate, and rapid enough to address the needs raised by current and future public health crises. All this not only in the U.S. but in every global market, including underserved areas. Talk about a big vision. I think we all experience the importance of at home testing from the COVID 19 pandemic. So we're really excited to dig in deeper here with Paul. Let's bring him in. Hi, Paul. Thanks for joining us today.Paul Chapman:
Hi Kelly. Pleasure to be here. Thanks for having me.Kelly Stanton:
So Domus came outta stealth mode just a couple months ago. We love hearing how companies got started. Can you tell us the story about Domus?Paul Chapman:
I'd love to. So, Domus was born during the pandemic actually a serendipitous meeting between the two founders on a ski hill in Utah. Our two founders John Reif and Harald Stock had never met before, but had skied the same hill for many, many years. And in March of that during the, during the pandemic 2021 they met on a chair lift and just in small talk, one asked the other, said, what do you do? And one said, I am a professor at duke and I'm doing X, Y, and Z. And what do you do? And Harald said, well, I start diagnostics companies and, and grow them. And so the two of them decided that they needed to have a few more runs together. And in the end came up with a very strong vision to create Domus Diagnostics on the foundational technology that is nucleic acid testing. With the simplicity and cost of antigen tests. So, the, the foundational patent is that they have, and, and we've licensed out of Duke is a one pot lyophilization technology, which lyophilizes so, freeze dries, all primers, probes, enzymes readout chemistries required in a stable lyophilized bead. And then through both chemical breakthroughs and through design breakthroughs just in a very short time, we've, we've managed to create a device that, like I said, at the outset has the ease of use simplicity and cost of, of rapid antigen tests. But with nucleic acid PCR performance.Kelly Stanton:
Nice. And, and you talk a lot on your website about the importance of nucleic acid testing. What are the advantages and benefits of that approach over the rapid antigen style tests?Paul Chapman:
So, ultimately I think it's time to result and sensitivity of the result. So, nucleic acid tests are usually positive before antigen tests are. So that's the time aspect. And the sensitivity aspect of it is that nucleic acid tests are the highest performing. So they're the gold standard tests in terms of sensitivity and, and specificity. And as we know through, you know, two, some odd years now of antigen tests though uh, an incredible device and very important through the pandemic As a measure of contagious, they're not always antigen tests. That is, they're not always positive when you're asymptomatic. In fact, they're often not positive. So there is that window of time that conversion window, for lack of a better term where you need to get that answer sooner. Now, during the, I guess the, the heat of the pandemic, we were testing to isolate at that point, travel schools, offices at home. So if you had a positive test for an antigen or a PCR test you would be isolating then. That was the purpose, main purpose of COVID testing. And so back then, it was also very important to have a high sensitive high performing test early on when you're asymptomatic, because the worst thing in a pandemic, especially is the walking well, people walking around, not knowing that they're infecting others and that's how you get dramatic spread. So, and so that was then during the pandemic and even then a, an antigen test would require a confirmatory PCR test, right. To be sure. So now we've shifted and I think. Everywhere in the world. Now you've got all the mandates dropping. There's no one wearing masks anymore. Everyone likes to feel that we've moved through this. And even though we haven't moved through this, we are now going to be faced with co-infections. Right? So this upcoming uh, we'll call it flu season now has the potential, and it's probably a pretty strong one, of being a flu COVID season at the same time. As the communities around the globe shift from testing to isolate, to testing to treat. And for that, you would need a differentiation of the viruses, right? Because any respiratory disease you will present the same to a doctor, it would be the same symptoms. So the American Medical Association even says that if you wanna start treatment or stop treatment, you need a nucleic acid. So, what we've done in a pivot for the company is while we were focused maybe six months ago on a COVID only test, the simplicity of our device has enabled us to manufacture a multiplex test for flu A, Flu B, RSV respiratory and virus and COVID altogether.Kelly Stanton:
Wow. That's incredibly powerful. Cuz then you can, you know, select which treatments would be appropriate for the patient based on that too. That's great. Absolutely. It doesn't require us to mail it off andPaul Chapman:
wait a day. no, this is a 30 minute test. Nice. And so, like I said, for, and, and you, you had said it in the outset, Kelly. Everyone's become quite used to testing themselves. My seven year old and four year old, know how to swab their nose and maybe not run the whole test, but as testing has moved, from the lab closer to the patient, either through point of care or through at home testing. I guess that's a benefit if you wanna call it that of, of the pandemic is diagnostics as a whole has been elevated to a different level, which is great for us. But as you get closer to the, to the patient, simplicity is an absolute must, right? The FDA demands that.Kelly Stanton:
Yep. And speaking of the FDA, so you guys are getting some clinical trials off the ground then?Paul Chapman:
Not yet. We're currently validating our, our hope is um, it's funding dependent cuz clinical trials are, are pretty expensive. Yeah, there is saying um, and we're waiting on, on governmental funding, some word down on governmental funding right now. So. If we were to get one of the, the governmental funding contracts we're talking about, we could very well be uh, in clinical trials, this Q4, which would, it's important because if you're running a clinical trial, you need those prevalence rates to be high in our expectation is flu season, again, for lack of a better term will probably be a flu COVID season. So that would be the best time to enter a clinical trial if our funding is somewhat delayed then we would probably be targeting a whole year uh, in getting into clinical trials. Because again, that would be the timing.Kelly Stanton:
Definitely. Well, and since your tests don't require instrumentation, electricity or cold chain logistics, um, you know, underserved areas, parts of the world become much more available. Your testing makes that sort of thing much more available to them. So in that sort of expansion, are there countries that you're already targeting or, you know, from a clinical trial perspective, that also might be an opportunity for you guys, right?Paul Chapman:
Well, yeah, we were originally targeting again many, many months ago. When you had, and again, this is my experience. I've been in molecular diagnostics for, for many, many years. And when you have the technology at your disposal that can be deployed in, in developing countries without instrumentation and with ease of use and simplicity that can be uh, run at the point of care. I think the onus is on you to make that test available to the places that they need it. So in the, in the process, though, again, as, as the world changed from that more hyperfocused on COVID and isolation and, and dulling the pandemic, and it's now shifted into this, this new multiplex requirement, our emphasis now is our fastest path to approval for us, would be in the states for a multiplex. And then after that, then we would move to W.H.O. approval and then deployment through the Indias, Africas of the world.Kelly Stanton:
Yeah. Perfect. Yeah, a lot of those countries do you know, sort of recognize that FDA approval, if you will. Uh, Yeah. So you cleared that bar. You should be good. And although it's interesting, you mentioned Africa, you know, I know they have some good easy to work with compassionate care laws in that particular country. I know some other countries around the world have those sorts of things, but, and I'm sure your regulatory teams across all of this, just sort of thinking about some of that from my perspective. And it, it is good to consider, you know, again, fastest path. How do we help the most people? That's that's awesome.Paul Chapman:
Well, I mean, this has been the call, like I said, if you want. I won't go as far as to call it our test, the holy grail, but the holy grail of testing is exactly what I said. And, and again, I started selling the first molecular test back in 1993 at Roche, and it was a chlamydia gonorrhea test, but at the same time, the impact of nucleic acid testing was already seeing that. Right. And the likes of the Gates was founded later on in 2000, but regulators, governments, NGOs were all begging for such a test to be deployed to Africa, HIV, for instance, or dengue yellow fever, tuberculosis, which Gates tells us now and find are still all tests that they're very interested in. And that, that test that we talked about that holy grail test still does not exist.Kelly Stanton:
Wow. Interesting. Well, so broadly speaking then uh, what would you say is the future of diagnostic testing over the next 10 to 20 years then?Paul Chapman:
Well, my hope is the future of diagnostic testing is Domus Diagnostics. But, and if before that I think the future of diagnostic testing and we hear a lot about it now is, is when, when folks are talking about pandemic preparedness, for instance. So, the ability to a) serve underserved population. So accessibility has always been, every time I woke up on the past, whatever nine months or a year. And, and we'd look at the television and you'd see the snake of cars and, and I would just, be killing myself that we can't move fast enough. Right. Accessibility was the key and still is the key. I don't think we've solved the accessibility question. When I say accessibility, I mean, not just regions of the world, but regions of the U.S. Right. A nucleic acid test that costs $50 is not an accessible test. Right. An accessible test is potentially a test that gives you four results for less than that, right. Or potentially much less than that, or for the cost of an antigen test. So where I think there's a few things, a) accessibility and that's in the form of simplicity of tests, simplicity of manufacturing. So you can get it out higher volumes that are cheaper cost. But then there's also the component of rapid turnaround and the ability to move again for the next oncoming or upcoming virus or infectious disease. And so, for that, and, and this is where we've also been able to, I think disrupt the market in terms of manufacturability, we for this test, because it's a laminate, which means you can provide uh, role to role manufacturing. It's not a bunch of injection molded pieces of plastic that all have to be assembled together. The laminate card, and the simplicity of the reagents, enable a very small footprint and a very high throughput footprint that can manufacture these tests at under like a multiplex test for under four bucks, for instance. Nice. Like that's a multiplex four target test that can be manufactured at 2 million tests a month in a, in a fully end to end automated capital equipment unit that would cost maybe 10 million at the most. So, and the other part of this is rapid turnaround. So back to our test that can only draw comparisons with our test at this point. But for us, the one pot lyophilization enables us to have our foundational chemistry be swapped out just by swapping out the primer sets and probes for a new target. And then that gets made into the, into the lyo-bead and that gets deposited into our little bead well on the test. So very rapid turnaround time. So we can be up and running with a new test very quickly. And the manufacturing template that can put that out at low cost anywhere in the world. And then it's again, accessibility making sure from a cost perspective and a performance perspective and a regional perspective, you're getting tests to the people that need them.Kelly Stanton:
Indeed, indeed. And that's a lot, but it's it's good to hear, you know, again, I, I think. That you've, it sounds like you're well on the path to solving some of those manufacturability challenges. So that's good.Paul Chapman:
I sure hope so. I sure hope so. Cause Hey, I I've been at Roche. I was at Roche for 15 years. Right. And I drove a lot of, a lot of very large projects. And Roche's a fantastic company, obviously. They're the biggest diagnostics company in the world, but instrument based tests are hard. Right. They are. Instrument based tests are hard to develop at low cost at high throughput, get them, you know, delivered to far off reaches of the, of the globe. And then just the development time. So for us, we have a laminate with a fluidic channel in it, chemistry, ized beads, and then a, a chamber. This big. That just has extraction buffer in it, in the swap. So the development for us doesn't require hardware, software, firmware, disposables, consumables, reagents, systems integration, for all of that. Then the valid, the, the development, the design for manufacturing, the validation is a much simpler process for this very simple device. So. That's why we have a high degree of confidence that I think we're going to, at least we can potentially change the game here.Kelly Stanton:
Sounds like it. We have a lot of life science entrepreneurs that listen and you're on the board and have built up several life science companies. Is there any advice you'd like to share with the audience on company building, especially we've got a little bit of a turbulent economic climate happening now.Paul Chapman:
So I uh, and this is advice I've given founders and CEOs in our discussions. And that is especially for founders because founders have their baby, right? Their baby is their product. What I've told founders is "I know you love your baby. And I think, and you, you think your baby is the best and most beautiful baby that there is. And I'm sure you think, you know, what's best for your baby. But I'm here to tell you that you have no idea what's best for your product." And the reason you don't have any idea is because customers are going to buy your product. And so they're the folks that should be telling you what your product can be. And I can tell you a number of different instances where I've had these conversations, where, you know, the head of the company and the head of R and D are arguing about what has to come out next in terms of a menu expansion or something. And I'd be in on these conversations and I'd say, "Why are you fighting about this? This is not your call. Why don't you go out and talk to customers?" Because when you build something inside a vacuum, and you think it's fantastic and you haven't gone out to the markets. You haven't assessed what the market is. You haven't got real customer requirements, customer inputs. Then you're gonna build something that you think is fantastic, but then you've got absolutely no pull. And then from a marketing perspective, how easy is it to go, "Hey, I've got this cool thing. You wanna buy it?" Or is it better to have their inputs on it? So that by the time it gets to. They want that thing because they've told you that's what they want. So that would be the first thing. The other thing is you know, startups are hard. I, I worked at very large companies, Roche. Millipore, and I had humongous budgets. By comparison to a startup, we raised 1.5 million dollars uh, in Domus in and closed in December. I can tell you number one, you're always raising, which I'm sure is it's everybody knows that, but, but secondly do what's most important, make sure you can focus your team, right. But focus also especially in small startup. Where the product is not clearly defined yet, focus is very important on your goals and what you have to achieve. Maybe this is gonna sound kind of contradictory. Focus is important, but the guardrails need to be wide. Right? Cause I can tell you back to Domus, if we had had very tight guide rails on what this product needed to be, we would've come up with a vertical injection molded bunch of pieces of plastic that was not game changing from a design perspective or even a cost perspective. Had very clear focus on what we wanted to achieve, which was simple, simple, simple, simple, and high performing. So we didn't add bells and whistles. It was all about how do we make this manufactureable at very high throughput, very low cost. So it can be, and again, the vision is important. Everyone on the team knows full well how important this test would be deployed in far off regions. So. I guess that was one, two or three things that I would say, but ultimately customer inputs are, are hugely important. Cash goes pretty fast. So make sure you're focused, but if you're doing something that's, that's potentially game changing in the market give smart people and creative people, the, the freedom to be able to get there because had we had, like I said, real tight boundaries, we never would've come up with this.Kelly Stanton:
Oh, I, I love to hear that. That's definitely in, in my experience, working with design teams. It's amazing to me, how few customer inputs start off at the beginning. And to me, those are the that's the end zone, right. We all have to know. So you have the creative freedom on how you get there, which is the guardrails, I guess you're talking about there, but you still have to have an end zone to hit. Right. And if we don't know what that is, or you don't know that you're gonna be able to sell it, it's also amazing to me how often people haven't considered, whether or not they're gonna be able to sell this thing, You know, and, and so you get all the way to market and, nobody will reimburse you for it, or, you know, you can't, they're not gonna buy itPaul Chapman:
You need to definitely have, have the vision and at least some competency to, to speak to how you're going to enter a market and not just enter, but, but compete. There was one more thing that, that was interesting. I had a friend of mine had a while ago, told me that there was the founder. There's two kinds of people in this. Those that raise money and those that don't raise money to which, to which I said, well, I thought that was odd because what do you do with the money once you raise it, right? You don't just keep raising money. So as a founder, if the goal is only to raise your next round, you're in deep trouble, goes back again to the product and the focus on the product and making sure your product is right. So when you raise money, you have to make sure of, theranos at the top of the list, right? You have to make sure that you're doing, especially in our game, you're doing the things that move you from a regulatory, so a design validation, clinical validation, you need data, right? Even if you wanna raise money, if you're going to be raising money in the life sciences space, hopefully you're raising money from folks that know what they're talking about. Those folks are gonna demand that you have some pretty solid data. So that's the other piece. It's not all about raising money and getting the next round and hyping. It's about doing the things that move you from step one, to step two credibly so that you've, you've got that credibility when you're going out and, and raising that next round.Kelly Stanton:
Definitely. On a more personal note, if you could go back and tell yourself something at the start of your career, what would that be?Paul Chapman:
I think I probably would've looked at the, the startup world earlier. I think I, I spent you know, 15 years at Roche, five at Millipore, a couple of years at Quantaris, which was a startup, but that's when I started in the, in the startup realm. Not until like 2012, I think, with a solid global experience that I had after 15 years at Roche, it startup might have been the next logical step because. There are a lot of things. A lot. There are, there are things that I had done in, in those companies where you create a new business or you create a new product or you develop a new product, all those skills in those larger companies where you have, you know, Unlimited funds. And I shouldn't say bro had unlimited funds, but again,Kelly Stanton:
no, I know what you mean though. but when you work's much bigger checkbooks there.Paul Chapman:
Right. But, but the skills that you learn and, and in those incredible organizations that are so, you know, tight when it comes to R and D and, and market, everything is, is well funded and well done. When I, after 15 years there, I probably had enough under my belt to go into the, into the startup world at that point. I wouldn't trade anything. I still think the path I took was the right one, cuz it, it brought me here.Kelly Stanton:
Well, where can people go to learn more follow, along and connect with you?Paul Chapman:
You can always contact us through the website. There's a, there's a icon there that you can, you can click to send any information or any requests into Domus at www.DomusDX.com. My personal email is Paul at DomusDx.com. If you wanna reach out to me directly And we often update, there's a, there's a nature publication on the website that you can look at, and any press releases or interesting information we'll put on there too. Best place would be the website.Kelly Stanton:
Great. Thanks a lot, Paul. We really appreciate your time today. What a great story.Paul Chapman:
Thanks a lot for having me again, Kelly. It was a pleasure.