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The Future of Lateral Flow Test Technology

May 25, 2022

How many COVID tests have you taken at home, in hospitals, or at drive-thru clinics? Are you sick and tired of the long wait times to access the tests you need? Do you worry about whether you followed the instructions correctly or not? Does it take too long to process results - only to get false positives or negatives?

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Jeremy Stackawitz, CEO of Senzo Health about his company's focus on improving current lateral flow test (LFT) offerings for new products with better performance. Jeremy has more than 20 years of experience in the healthcare industry and Senzo Health is an in vitro diagnostics and point-of-care company working on COVID-19 technology. 

Would you like to participate in an AMA (Ask Me Anything) session with this speaker? Head over to community.greenlight.guru and use the access code 'TrueQuality2022' to see what AMA’s are coming up.

 

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Some highlights of this episode include:

  • Positive vs. Negative Test Results: Jeremy discusses the pros and cons of COVID testing by using lateral flow products to increase the time to results and improve performance. 

  • Supply and Demand Constraints: Senzo Health’s reason for being is to offer a better test that resonates with end-users, government contractors, healthcare providers, and others.

  • Main Barrier: Lateral flow tests are simple, but the technology and performance is limited. However, these tests could be good tools to use to monitor your own health, are relatively inexpensive, user-friendly, and fast.

  • Data: With new technologies, Jeremy gains confidence and believes in Senzo Health’s products because of data generated and shared with investors, regulatory bodies, and other people in the industry.

  • Healthcare reform? People are genuinely interested in having an active role in managing their health care and know the system is broken. It makes more sense to bundle tests, take in one place, get results fast, and develop a treatment plan. 

  • Mitigate Risk: Make decisions based on priorities, different technologies, and limitations. It takes the right technology, team, and vision - know when to pivot.

Would you like to participate in an AMA (Ask Me Anything) session with this speaker? Head over to community.greenlight.guru and use the access code TrueQuality2022 to see what AMA’s are coming up.


Links:

Jeremy Stackawitz on LinkedIn

Senzo Health

FDA - Emergency Use Authorization (EUA) Pathway

FDA - 510(k) Pathway

Teladoc

Theranos

Greenlight Guru Academy

True Quality 2022

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

Memorable quotes from Jeremy Stackawitz:

“Our test is 10,000 times more sensitive than the dozen or so current offerings that you can buy.”

“People have realized, ‘Wow, these could be really good tools for me to use to monitor my own health, they’re relatively inexpensive, they’re fast.’”

“With new technologies, what gives you confidence is seeing data and then seeing data in other people’s hands.”

“I think our problem will be not so much finding a home for the technology, it’s going to be prioritizing what the best match for what our technology can deliver and the unmet needs in various markets.”

Transcript

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Etienne Nichols: Hey, everyone. Welcome back to the Global Medical Device Podcast. This is Etienne Nichols, your host of today's show. Today with me is Jon Speer, the host and founder of Greenlight Guru. Today, we have with us... You know what? I should have practiced your last name, Jeremy. Jeremy Stackawitz, did I get that right?

Jeremy Stackawitz: You got it. Great job.

Etienne Nichols: All right. He is the CEO of Senzo Health. They're a diagnostic company, working on some very specific technology to help with the COVID pandemic. So, we're excited to hear about what they have going on and some of the journey they've gone through. Jeremy has extensive background including not only managing different devices, but also working with companies, taking them public on the NASDAQ. So, he has a lot of experience from start to finish. So, maybe we can get into some of that, but you want to talk a little bit about what you all have going on at Senzo very quickly.

Jeremy Stackawitz: Yeah. Thanks, Etienne. Happy to. Yeah, very exciting company with Senzo Health. So, we are an in- vitro diagnostics company, a point of care company, and our focus is really about improving current product offerings through better performance. So, we've discovered a novel approach to lateral flow tests. So, we maintain all the great things you love about lateral flow, which is you can throw them in your drawer of your house or your medicine cabinet. They're relatively inexpensive. They're easy to use, and they've been a great tool in the pandemic. So, we're building on that. There's nothing about our technology or our products that are different or a drawback from that. We're able to speed the time to result. So, when you have a child you're trying to get to school or decide whether you're going to work or try to get into an event, we have a 7- minute test versus 15 minutes for most of the current COVID tests. So, that's eight minutes of your life times however many times you need to take the test, which we think is important, but the real breakthrough is around the performance of these tests. So, we can discuss the pros and cons of the current products, and I'm a big supporter of what the industry has been able to do. And with government backing to bring these to people, they've certainly helped us make large progress and return to some semblance of normality in our lives by having these tests. And that's wonderful, but there are some limitations to them. And most notably in the early stages of COVID infection, it's very likely that you have been infected and you are contagious and you are doing all the right things by taking these tests and trying to be careful and a responsible member of society. And they're telling you you're negative and you're going to the grocery store and doing different things, where in fact, you are positive, which you'll find out two days later either by a PCR or a sequential test. And we're really trying to eliminate that window in the simplest terms where our test is 10, 000 times more sensitive than the dozen or so current offerings that you can buy. And that allows us to pick up virus very, very early and give you that early warning that might be the difference between infecting family members or others. So, that's what we've been working on. It's not limited to COVID, but that's our first application. And we can talk more about other areas where we think this could go, but in the here and now, we're certainly hoping to bring this product to market this summer so soon and have it ready for next fall. I think we're all waiting to see what surprises the pandemic will bring us next, but we want to be ready with a better test.

Jon Speer: Yeah, I'm going to say I'll be a fan of no more surprises first and foremost. Let me go on the record for that, but I 100% agree with you. It's so encouraging to see how industry has responded. Medical device development in general is the long game, so to speak. It's generally not for the faint of heart, but to see how quickly so many companies, both existing medical device companies and then also some others who were in other industries, how quickly they responded to develop tests and swabs and ventilators and all of these things that were needed has been encouraging. But to your point, many of those products followed what is known as the EUA, Emergency Use Authorization pathway. I've talked about this on the podcast before quite a few times. There's a lower barrier to entry for EUA device. Hence this might be why we're seeing some of these tests are more precise and more accurate than others, which is good that they're there, but only good if they're precise and accurate. So, yeah, that's two edges to that sword, right?

Jeremy Stackawitz: Absolutely. And it's interesting, it's all relative as well. So, certainly, the EUA pathway and that's the pathway that we're pursuing as well. So, we've had great dialogue with FDA. I have to say they've been very supportive. I think they see the value in our tests and want to, objectively, but they want to help facilitate us bringing it to market. And that pathway is easier than the normal 510( k) pathway or at least it's faster. I mean, to some degree, just to calm people out there, all the things that you need to do around good manufacturing practice and the quality of your product and clinical trials, it's not that different than the 510(k). It's really the review period and some of the other things that have been shortened, which I think is a great idea and it's relative, right? So right now, there are 14, I believe, products approved for over- the- counter, at- home rapid test use. And on one hand, there are probably 100 PCR tests for lab use. And so, the FDA has been judicious about putting these in the hands of consumers and probably rightly so. And to your point, I mean, the corollary is in Europe, there are hundreds of these. So, Europe with CE marketing has taken a very different approach and a more laissez faire approach of just let them on the market and the market will decide whether they're good or not. And we've seen good things come of that and bad things come of that. The UK made some early bets on tests that were very poor. So, there is a little bit of a damned if you do, damned if you don't. The FDA and the US government by limiting to only 12, 13, 14 tests, that makes us feel good about the tests that are out there, but we've seen continued supply constraints. The biggest diagnostics companies in the world are the ones making these tests and they still can't catch up with demand. So, Senzo's reason for being is we're not going to make a dent in the overall supply chain or availability, but we can offer a better test, which we think will resonate with end users, the government offering contracts, epidemiologists, healthcare providers. And how it plays out on the supply and demand, we'll see. My guess is we're probably going to catch demand with supply over the summer. And then again, we'll see what happens after that.

Jon Speer: Yeah. I mean, the other thing, obviously, I think at the stage of the game, we've probably have all taken at least a few at- home COVID tests. Some of them are easier to follow than others. It's like, " Did I do that right?" And I could see where one may think that you follow the steps in the directions and you get a false negative result and you find out later through PCR and other means that maybe you had it the entire time. Maybe I didn't follow a step right. Whatever the case may be, I mean, that's maybe a whole different conversation with respect to human factors, but you said something a moment ago about lateral flow and something about we all love lateral flow and we love to throw it in our door. Tell me more about that. I mean, are there lateral flow devices or products that maybe I'm familiar with that I didn't realize were lateral flow products?

Jeremy Stackawitz: Yeah. Yeah, Jon. So, what I would say is before COVID, the vast majority of anyone's experience anyone as a lay user or at- home use or buy it in the store with lateral flow was pregnancy tests. So, pregnancy tests are far and away the biggest seller and what most people have been exposed to in their lives. There are a couple of additional tests that have made their way to market pre- COVID for HIV at home testing and monitoring, but it's a pretty limited number. That expands a little bit more for professional use. So, perhaps you go into the clinic and get a quick test for a culture for bacteria, something like that. But again, most people probably hadn't used a lateral flow and didn't know what it was other than outside of the pregnancy test realm. Now, we've gone from 0. 1% to 90% of people have now taken one of these tests. And I think that's a good thing, because this whole experience, I think Scott Gottlieb, the ex- FDA commissioner, has commented on this. He really hopes that it loosens the FDA up a little bit as well, because they've been part of it. But the main barrier here is it's a simple test, right? It's a visual readout. There's no software. There's no instrumentation. And so, the technology is limited what you're able to do with it. And that's limited the performance, which is limited the FDA's desire to have these work. And if people are using it at home but no healthcare provider trusts it, that doesn't get you much. And so, where we really see, I think, in general COVID has helped because it's made people raise their game about these products, but it's also gotten people comfortable. And I think people have realized, " Wow, these could be really good tools for me to use to monitor my own health. They're relatively expensive. They're fast. You can combine this with the growing use of Teladoc. And really quickly without leaving your sick bed, you can derive answers and take that all the way through to a conversation and a prescription." Part of the reason that there isn't a lot of use of treatments for the flu is no one gets diagnosed soon enough for it to matter. And that could change with a really good at- home flu test combined with a quick chat with your primary care doc and then you've got a prescription an hour after you woke up with the sniffles. So, I think there are a lot of dynamics here that really open this up to be a great time to have more of these kinds of tests, because I think they are really important tool in the diagnostics world. Senzo in particular, because of our ability to have incredibly high sensitivity across all sorts of infectious diseases, small molecule, viral, bacterial, our view is with COVID, we'll have a better test, but for a lot of these other applications, it's more binary where the current technology is just not going to allow you to enter the market period, whereas we can and then you can replace some of that central lab testing. One other point I wanted to make when we were talking about using the tests, one good thing the FDA's done and it's a hurdle for us, but in addition to generating clinical data in your clinical trials, which is what I'm used to for the vast majority of diagnostics products, you also need to do usability studies. So, you do need to show that people can use this without completely screwing up the testing. And so, there are safeguards in place just so everyone knows and we're really confident in our product, but it has been interesting to see the different kinds of products that end up out there. You can pull three different tests off the shelf and they look completely different. And what's interesting, our format is more of what I would call the traditional format, where there's a solid cassette. You add a sample, you read a control line. It's all self- contained. We think it is very user friendly. And most of the tests in Europe are that way. A lot of the tests in the US are that way, but interestingly, the two market leaders are not that way.

Jon Speer: Yeah, I've taken those. It's more of a strip chemistry, where it's like you're at home chemistry test or a set when you were a kid. You got these little tubes and put some liquid there and do this and that and then drop it. Yeah, a little more labor intensive, but nonetheless.

Jeremy Stackawitz: I was surprised as well at some of that. Again, I don't want to bang on the current test because I think they've made an enormous dent in our ability to feel good about where we are with COVID. But I think when you see the pristine clinical data that ends up in their IFU, that shows, okay, I have 80% sensitivity. That's in a pretty controlled environment. There have been a lot of papers published that in reality, when you're taking all comers asymptomatic early infection, that's probably closer to 50% and it's the best all of their technologies can deliver. I mean, it's certainly better than nothing, but we think there's substantial room for improvement. And the way I always look at it is if there's even a 1% infection rate, which depending on where we are in various parts of the pandemic, it's often far higher than that. But if you're with 200 people, right, two of them have COVID. And if the sensitivity is only 50%, one of them has COVID and thinks they don't have COVID and they're at school. They're at work. They're on your airplane. And when you start thinking of it that way, you don't have to go to really big numbers to find that a lot of people who are trying to do the right thing and hoping that everyone else is doing the right thing are doing that but are still spreading virus. And I think with Omicron, we saw that even more so. Omicron is harder to pick up. So, you get more of the false negatives but is more transmissible than previous variants. So, again, you have people that are passing it along unwittingly basically.

Etienne Nichols: When I hear about a company like Senzo and just hearing a little bit about, obviously, your technology is super cool, I think of it as coming up to a car and the car's beautiful. And so, I want to hear about this company, but if you pop the hood and I don't know how much you can talk about under the hood necessarily, but you did mention a few things I was curious about. Your relationship with the FDA for example. I guess you're a believer in this technology 100%. The company itself, obviously, companies are more than their technology. What makes you a believer? And can you tell us and maybe give some pointers to other companies who may be in a similar route or something like that? What makes you a solid believer as far as that goes?

Jeremy Stackawitz: Yeah, thank you. Well, I think in general, with new technologies, what gives you confidence is seeing data and then seeing data in other people's hands. So, when we first made this discovery, it looked great on paper, then it looked good with a little bit of experimentation. And the more data we were able to generate and then also putting in the hands of others and having them generate it gives us confidence, gives our investors confidence, and I think gives the FDA confidence. So, as we've discussed with them our trial protocol and our plan for bringing the product to market, we share with them data that we've already derived and they see, " Oh, wow." I think, I can best capture the majority of discussions we've had with all types of different people have been if what you're telling me is true, this is a game changer, but who are you guys? And I'm not sure I believe you. And that's a fine response to me, because we're able to show it to them that it is real and it is meaningful. And again, one of the advantages of these rapid tests is relative to other technologies or your example of a car or a large piece of automation equipment, it's hard to have other people test your product out for big technologies and things like that. It's a nice thing about these rapid tests. I can just send you 50 and you can figure it out for yourself. So, I think what Senzo has done is made an amazing discovery. This is a pretty recent discovery. It really happened last summer, summer of 2021. And I think what we've done best has been nimble and flexible and it's always the challenge of a small company that is underfunded and under resourced. Where do you pick your battle? And so, we have some other products and innovations that we've been working on, but frankly, when we made this discovery, we realized pretty quickly we had something special. And we were able as a small company to make that hard decision a little bit to focus resources differently, but we were able to do it and be nimble enough to put all of our efforts behind this technology. And really from something that was discovered on the bench in June, July, August to now have a final product ready to go into clinical trials is pretty fast. And I think that's the key. It's believing in something and going in after it full force and then have partners that believe in you as well. So, we have people, whether they're investors or other partners that are helping us deliver this technology, that all those pieces have to come together. And I think what was important for us is it's not a one trick pony. So, there may be risk in going into the COVID market if magically COVID disappears. That unfortunately is not our view, but we can take this as a technology platform into all kinds of other areas, completely independent of COVID or as a hybrid. For instance, we'd like to bring to market a test that triple X the tests COVID, RSV, and influenza all in one shot. And it's likely that the current tests will not be able to do that or many of them won't be able to do that because they won't be good enough for RSV and for influenza. But the way I look at this is if you wake up with head cold sore throat, maybe three years ago, you ignored it and went to work anyway. Maybe you didn't go to work, but you certainly didn't get a test or talk to your doctor. I think those days are gone. And when that happens next September, people are going to continue to test and it'll be great to know, " Yes, I have COVID," or" I don't have COVID." But if you don't have COVID, you're still going to say, " Well, I have something." And being able to in that same shot with a single swab, single sample going in and saying, " Oh, guess what? You don't have COVID but you have influenza." And then as I mentioned, because there are treatment options, you can actually do something about it other than just quarantine for a little while. So, a lot of exciting places we can take this and would like to take this.

Jon Speer: Yeah. I'm glad you brought that last bit up because I was imagining, I know my wife recently got an at home test for... Oh, I don't remember what it was, but she took a blood sample. And it's a big company and I won't say their name, but they have commercials and all these at home tests. But it's become more prolific for sure. You mentioned the pregnancy test. Obviously, that's been something we're familiar with for quite some time. COVID tests have become more of the norm, but just like other tests, I know what my blood type is or I know what my genetic predisposition for X, Y, Z is. All these sorts of things are becoming more and more commonplace, but where am I going to keep all these individual tests? I mean, can I just take one test? So, I'm glad to hear that Senzo is thinking, not that you'll be able to accommodate every single type of test into one packet, but at least that you'll be able to bundle some things together. So, it's good to hear that.

Jeremy Stackawitz: Yeah, and I think you raised a greater point about all of this. I think people are genuinely interested in having a more active role in managing their healthcare. I also think they see a pretty broken process where we go to a primary care doc, have a conversation with them when neither of us know anything, then leave with a prescription to get a test, go somewhere else, get that, and then someone reads you the results over the phone a week later, and then nothing else happens. It seems incredibly backward that it would make a lot more sense to get the information either ahead of time or quickly while you're at the doctor's office. You sit down and discuss it together and come up with a treatment plan.

Jon Speer: Absolutely.

Jeremy Stackawitz: And then go home. And so, that's what we're trying to drive towards.

Jon Speer: The healthcare system. I don't want to get into all the talk about healthcare reform, but anyone who thinks we got that a few years ago is, sorry, wrong. Healthcare reform, we're far away from that. If I can take more of a proactive role in my healthcare as an individual, and to your point, if there's opportunities where I can engage or work with my primary care physician or other physicians, I mean, for whatever issue I might be seeing them for, and we can get a test and results in that visit, that's way more efficient, right? I mean, why would I want to go to the doctor? Doctor says, " Oh, we're going to order a blood panel." So, you got to schedule that maybe at the same facility, maybe not. You got to do a fasting one probably. So, you got to coordinate that and then you get the results. And then you get back to your primary care doctor to review the results. There was at least two visits that were not necessary.

Jeremy Stackawitz: Yeah, and the world is driving that way. I mean, there are very large companies, retailers that are very keen on having you do all this testing while you're in their store, right? And so, you can show up, take your tests fast, then get some food for a half an hour and then come back and meet with your doctor and you have all the results. And it makes a lot of sense. And the main limitation to that model has been the technology itself. It's fine to get the retailer and the doctors to all come on board, but you still need tests that are good and can work quickly. And it's just taken a while to get there, but I think we are. And with the rapid tests like ours, we can do different versions as well. With COVID, it's mostly fine to be standalone. People read it and then make a decision about, " I'm fine to go out in the world. I'm not fine to go out in the world," but we will add infrastructure around that. So, that if you do need help taking the test or you do need a more official documentation for some purpose or you want it to be part of your medical record to send to your physician, we can do that. And really when you get outside of COVID, that becomes not just nice to have. It becomes absolutely necessary in a lot of different ways, but also having really good tests is important. And I think there's real value in not having to wait either to order a kit to draw your own blood and then send it out. I mean, it still takes a couple days or to go into your doctor. Being able to do that at home is important, but everyone needs to believe in the results. I mean, if you take an easy example of HIV, having false negatives is a real problem and having false positives is a real problem. And so, you can't have either of those. So, the tests have to be really, really good. Or another example is we think we can do some really interesting work around drugs of abuse. So, employee testing or whatever that might look like, where again, you can do it quickly, inexpensively, privacy, but at the same time, you don't want to rely on people self- reporting their drugs of abuse tests. So, you need to have some technical infrastructure around that as well that validates results and that the person taking it was the person that is reporting the result and all that. So, there's some infrastructure and apps and kinds of things that we're working on as well as we go into new areas to support the tests.

Jon Speer: Yeah. That's cool. Etienne, I could go on and on. I don't want to hog the show, so I know you got things.

Etienne Nichols: Oh no, no, no. And I love that you're mitigating the risk by pursuing these or at least considering these additional indications. I guess there's obviously a long term strategy when you're approaching these, especially with the potential for the termination of EUA. Always keeping the eye on the ball as far as those design development activities go. Can you make any recommendation? I don't want to pry into necessarily what you are doing. Obviously, that could be potentially company secret and so forth, but recommendations you have for companies moving forward, others who might be trying to mitigate risk in a similar fashion.

Jeremy Stackawitz: Yeah. I mean, I think the way we try to look at it is we're resource constrained to some degree for now. We're hoping to remedy that with investment coming in the coming months and quarters, but even so, you can have all the resources in the world, you still need to make decisions about prioritization and those sorts of things. And so, I like to look at objectively what the technology is and what it isn't and where you could take it. So, a good example is while we can multiplex in the sense of within a single cartridge, we can have probably 2, 3, 4, maybe 5 tests, there's a limitation where you're not going to be able to do a rapid test for 50 oncology markers. There are some diagnostics like I'll pick the one everyone knows, cholesterol. They're inherently quantitative tests that also isn't going to happen on a lateral flow rapid test. That doesn't mean it can't happen point of care in five minutes in a deli or a pharmacy, but that's a different technology. So, when I look specifically at our lateral flow, it's diseases where the current testing just isn't sensitive enough, not specific enough and there are a lot of those. And then you can also cross that with... We're mostly talking about the US or European markets or developed markets, but there are all kinds of applications for inexpensive, easy to use, can store it room temperature, long shelf life in developing world markets where malaria, tuberculosis, where they just don't have access. Yeah, you could do it with PCR, but realistically, that's not an option in a lot of these places. So, we're also looking at those applications that are more limited by resource or just things that you want to have in an ambulance or the military might want on front lines, things like that where you don't have to be carting around a 800- pound instrument that needs to be trained and calibrated, having these things that are extremely durable and can rapidly get you a result. So, I think our problem will be not so much finding a home for the technology. It's going to be prioritizing what the best match for what our technology can deliver and then unmet needs in various markets. And we'll do some of this ourselves, but we see the value in partnering, people who understand technologies or different regions or disease states or maybe someone has an amazing antibody or content but doesn't have a way to deliver it. That's a perfect match for us where we have the delivery technology and it's about bringing in the right combination of targets and antibodies, antigens to deliver on the test itself.

Etienne Nichols: I think that's a great point. There's two different situations that some companies get into where they get laser focused maybe on a user population and maybe they missed the mark. Maybe there's a better one out there, but then the other side of that pendulum is you try to fix the whole world and boil the ocean. You don't get focused enough. So, you bring up some great points there.

Jon Speer: It's knowing when to pivot. To your point, Etienne, I think sometimes people get so narrow minded and absolute that they're not paying attention to the signs that says, " Hey, you need to pivot here and here's why."

Jeremy Stackawitz: Or the market or competition. My experience and I don't know if this is advice to others, but I think it's a little different for the first one and then it gets a little easier there. To some degree, you almost have to pick your horse and be laser focused and then make sure that it goes well both in you deliver a product that works and then it gets some market traction. I think it's hard to pick 10 things and move them all along at the same pace.

Jon Speer: Especially if you're resource constraint, which every company, regardless of shape and size, is resource constraint.

Jeremy Stackawitz: Yeah. So, I think you need to pick that lead horse, get a win, build credibility, and then it gets a lot easier to pick the next five.

Jon Speer: Yeah. So, question, this one might be a little bit more controversial, but I'm sure you'll play along. We've all heard by now about Theranos. And I remember when I first heard about it, I'm like, " Oh, my goodness. That is amazing." And then things unfolded and we learned the truth. Did they spoil it for everybody or did they change the perception of the diagnostic space, good or bad? I mean, what are your reactions to what Theranos has done for companies like Senzo and other diagnostic companies?

Jeremy Stackawitz: Yeah. So, my first reaction is they ruined it for five years, if not more, from an investor's standpoint and a credibility. Not for all of diagnostics, but for point of care diagnostics, but I think we're past that. And I think what's cured that a little bit is they went away and yeah, the trial's still ongoing, but again, I think technology has now caught up. Other companies have launched products, whether they're big companies or new companies that work great. And so, again, you build back that trust and credibility bit by bit. I think we're over the hump and COVID's helped with that. My view is in one sense, they were visionaries and correct in where the world was going and what consumers want and retailers want. And that ties back to what we were just talking about of getting your testing in the back of a big box store or at a clinic, which now there are a million times more clinics around than there were even 10 years ago. So, in a way, I think they saw where the market was going. I think the problem was their technology was never good enough to pull that off and they just got deeper and deeper in making the promise and hoping that they would catch up on the technology front and they got caught. So, I think their view of the world, in some ways, the investor's view of, " Huh, this could be really big," and where things are headed was probably right and in a way ahead of their time. But in some industries, you can fake it until you make it. That's a very dangerous game in science and diagnostics, because the technology might never cooperate, which is what ultimately happened to them. And then you get forced into doing very bad and it damaging things. So, yeah, it was hard on the industry. It was hard on small companies and point of care for a long time, but I think we've come back out of that now.

Jon Speer: Yeah. Thank you for sharing your perspective on that. I think it goes back to what you mentioned at the beginning of our conversation today. It's put more emphasis on good science. There's a saying that I heard years ago from a colleague, " In God, we trust. All others bring data." And I think that's where we are today. And I think that's encouraging actually, because I mean once upon a time, diagnostics companies, the money that they were raising, oh my, goodness. A series B would be like$ 100 million round or something crazy like that. That is not sustainable. That is crazy.

Jeremy Stackawitz: Yeah. And I think with lots of industries, you get that hype and then back to reality and then hype again. And I think diagnostics is certainly having a moment because of COVID and I think that's generally positive, but this time, it's backed up by reality, right? It's not just betting on the come that something might happen. It's largely been products that are real and on the market and can be manufactured and used and work. And so, I think there's just inherently a lot more realism around it. And partially with the Theranos story, I think investors can invest in whatever they want. Caveat enter, it just became such a big story because of the Wall Street Journal and everything else. But I think there was always a large group of healthcare investors and people who knew the science and technology that always looked at that slightly skeptically.

Jon Speer: Yeah, for sure, for sure.

Jeremy Stackawitz: But no, I think it's a good environment. We've seen a lot of company. There's been a lot of M& A activity in diagnostics. There's been a lot of IPOs and that filters all the way back to companies that are on the front end of that like Senzo, where certainly, we'll be looking for funding and we believe that'll be a terrific investment as we can bring this platform and products to market.

Etienne Nichols: I think, as far as investors and just bringing your product to market, having that open dialogue with the FDA, the evidence that you can show with that and also the ability to show that or just provide your product and they can easily see and compare, that's powerful. That's pretty cool.

Jon Speer: And what I've loved about what Jeremy shared with us so far, a couple things I've picked up is it's the right combination of a technology, a team. In the case of Senzo, they've identified what they believe to be a platform technology. The first horse they're riding is that COVID application, but there are plenty of other things in the queue, but it's that ability to focus on the near term, the short term or the shorter term, but having a vision to see the longer term. Don't ride that horse until it dies. Give that horse a break. Let it get some water. Find another horse and ride that horse and that thing. So, I don't know. It's that combination that I think sometimes especially startups, I think they don't strike the right balance. Maybe they're overemphasizing the team or overemphasizing a technology and they forget about some of these other things. So, I think it's good to have that balance.

Jeremy Stackawitz: Yeah, absolutely. I think there's traps in both picking a market and saying, " Come hell or high water. I'm going to invent a new test for X," or the other way around. I'm only going to do this technology and we'll just have to find a market or create a market. I think, both of those approaches can be a little dangerous, so you just have to be flexible and go with the flow, see what the tea leaves in the market and what smart people are telling you. And credit to the Senzo team, I'm a relatively new joiner. So, I want to give credit to the founder and the lead scientist to try new things and make this discovery for instance and then be able to shift and rally behind it and not halfheartedly, right? Sometimes you pivot, but if two- thirds of the company still isn't behind it, you're going to fail or you're going to struggle. And so, credit to my Senzo team to be fully engaged around a bit of a pivot.

Jon Speer: Absolutely.

Jeremy Stackawitz: And it makes it a lot more fun, right? I mean, I think, part of it is people invest in people, people want to work with people, and people who are passionate and believe in something. And so, I do my best to represent our team that way and put off that excitement about that, because we really have this and believe that this can be a game changer and are proud even for as far as we've gotten it and would love to be a contributor to better healthcare.

Jon Speer: Yeah, I could speak for certainly myself and I think a lot of my colleagues at Greenlight. We've tried to foster and enable a really healthy culture and it helps that we have a product that our team can believes in, because we know our products and services make a difference. So, I think that's my advice to anyone out there who is looking to start a company is get that combination right. Foster positive culture, but develop something that your team can get behind and believe in. That makes a difference, a positive impact, whatever that might be.

Jeremy Stackawitz: Yeah, absolutely. Another thing that I really like about lateral flow in this technology. So, we have picked a couple of other areas where we've shown proof of concept like influenza, RSV, tuberculosis, even prostate cancer markers. And what we've seen once we have the base technology established around ALF or amplified lateral flow, picking a target and bringing in positive and negative samples and antibody to find it, the development time is incredibly quick and that in of itself is rewarding. And so, I do think not everyone has this luxury. My previous role in previous company was a very, very long R& D cycle. And I think look, sometimes it just takes seven years to bring an amazing new product to market, but it gets hard. And so, there's something nice about concept to product on the market that people are using in a year. It's just a lot easier to maintain momentum and energy and then be refreshed by saying, " Man, it works. People are using this. Let's move on to the next one." It's sometimes harder to play that five- year game and just maintain enthusiasm, if nothing else.

Jon Speer: I get that. That makes a lot of sense too. Yeah, for sure. Yeah.

Etienne Nichols: I totally agree. And I've managed projects that end is nowhere in sight. So, I'm curious what you would say on that. I know we're getting close to time, but you peaked my interest there. When you do have a seven- year project or a lot of our customers may be working on something like that, in my mind, I mean, you almost have to set artificial milestones that we're going to celebrate when we get to X. What are your thoughts there? How does that work? Have you seen that?

Jeremy Stackawitz: Yeah, absolutely. I mean on a big project that long, you're going to have detailed project plans, but you'll have key milestones where you say, " Okay, the software for the instrument is done." And then yeah, you celebrate a win. You pack that away and then say, " Okay, now we need to connect that with the hardware and then there's the assay itself." And so yeah, you can create wins along the way that are legitimate. I think investors look at it the same way, right? If they're investing something they know isn't going to have revenue for five years, there've got to be tangible markers along the way to know you're on the right track. And so, I think that's how you have to manage it and you have to be clear about what those important points are. And some are obvious like a successful clinical trial. You still may have a bit more time before you have a final product, but I do think there's just something about seeing your product on a store shelf or knowing that a prestigious lab bought your lab equipment is now using it to test all the citizens of a country or something like that. There's just something about that that's hard to replace with interim markers.

Etienne Nichols: Totally agree. It's like a forcing function. You can't help but celebrate those things. That's pretty cool.

Jeremy Stackawitz: Yeah, yeah. So, I'm sure it's the same with automobiles again. When they finalize the drive train, I'm sure there's a celebration, but seeing it in an actual showroom and having people drive it out on the road is a whole other level of finality, I guess.

Etienne Nichols: 100%. Well, this is really good. Where can people go to find out more about what you all are working on?

Jeremy Stackawitz: Yeah. And so, easy enough, senzo. com, S- E- N- Z- O. com. You can find me, Jeremy Stackawitz, on LinkedIn. Senzo's on LinkedIn. We try to be pretty active on all the social medias. We just put out an interesting press release yesterday that really shows that people want better COVID tests and that have experience with maybe false negatives. So, we're trying to get the word out about Senzo and that our ALF COVID- 19 product will be available this summer. So, stay tuned, but really appreciate the time and the ability to talk a bit about this and the diagnostic space with you guys.

Jon Speer: That's interesting. Thank you.

Etienne Nichols: Any other thoughts, Jon?

Jon Speer: No, it's just good to hear the perspective of someone who's been there, done that, and doing it again. I hope those in the audience listening, who aspire to bring new products to market and grow their companies, there's a lot of nuggets and pearls of wisdom that Jeremy shared with us today. So, I hope folks are taking notes on this, but good conversation. Thank you.

Etienne Nichols: Great.

Jeremy Stackawitz: Thanks. Thanks guys.

Etienne Nichols: Yeah. Appreciate you getting on the show today with us, Jeremy. I thought it was a good conversation. To those of you who've been listening, you've been listening to the Global Medical Device Podcast. This is powered by Greenlight Guru, the only medical device success platform that is designed specifically for medical devices to get you more efficiently to market. Any questions, go over to www.greenlight.guru. Find out more, reach out to Jon or myself. Love to talk more about that. As always, thanks for listening and we'll see you next time.


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Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...