Saving Lives by Cancer Prediction and Detection with Dan Lunz, CEO of Previse

Today we interview with Dan Lunz, co-founder and CEO of Previse, an innovative medical solutions company specializing in cancer prevention and early detection. Lunz talks about his journey from being a Marine to leading a pioneering medical company. He discusses the scientific technology behind Previse, which started out as research for predicting esophageal cancer in patients with Barrett's esophagus. Lunz also shares about the company's current fundraising activities, commercialization plans, compliance with regulatory standards, and long-term goals for cancer detection. He hints at exciting future announcements about Previse's new developments, tests, and pipeline technologies.

https://previsedx.com/ 

https://www.linkedin.com/in/danlunz/ 

00:43 The Journey of Previse: Aiming for Early Cancer Detection
05:24 The Previse Technology: A New Approach to Cancer Detection
07:45 The Impact of Previse in the Medical Field
10:13 Fundraising and the Future of Previse
14:51 Navigating the Regulatory Landscape
18:02 Balancing Innovation and Compliance
21:15 Long-term Goals and Future Developments

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Music by keldez

Transcript

0:01

Hi there! Welcome to the From Lab to Launch podcast by Qualio, where we share inspiring stories from the people on the front lines of life sciences. Tune in and leave inspired to bring your life saving products to the world.

Meg Sinclair: 0:17

Hi everyone. And thanks for tuning into From Lab to Launch by Qualio. I'm Meg, your host. Glad to be here and really excited for today's episode. Before we get started, we'd love it if you rated the podcast. It's easy to do and share it with any of your science nerd friends. We know you have some. And if you'd like to be on the show, please see the show notes for an application. Today, we're joined by Dan Lunz, co founder and CEO. Previse. Previse is a pioneering medical solutions company specializing in the prevention and early detection of cancer, focusing initially on esophageal cancer. The Previse journey began as an exploration into a technology's viability for predicting esophageal cancer in patients with Barrett's esophagus, and it quickly revealed a genuine need among gastroenterologists. We'll get more background into the We'll get more into the background during the interview, and you can learn more about the Previse in the show notes as well. Dan Lunz is a former US Marine and researcher at Johns Hopkins. He's been leading Previse since 2020, and we're excited to learn more about his journey from lab to launch. So let's get to it. Welcome to the show, Dan.

Dan Lunz: 1:30

Hi Meg. Thank you for having me.

Meg Sinclair: 1:32

Yeah. Can you share a little bit with, uh, can you share a little bit with your journey about what led you from a Marine to the CEO of Previse and what inspired you to focus on early cancer detection?

Dan Lunz: 1:45

No, thank you for the question, Meg. Um, so I joined the Marines straight out of high school and real interest in serving God and serving my country. And one of the things that, uh, that I found in my story and impactful pieces is this, uh, this purpose that I feel to serve others. Um, so, so I served in the Marines from February, 2005 to February, 2012. Upon getting out I found my way into the VA hospital and, uh, and as a patient, um, and it was, Uh, military related, uh, uh, health issues that I went into the VA for. And that was my real first exposure into health care. I found an interest in the mental health side and what's called kinesiotherapy, using exercise as a form of, uh, of treatment for physical, mental, emotional, um, uh, conditions. And that was my first realization that this is what I wanted to do. In some capacity, I. Wanted to be involved in health care. I didn't know if it was physician scientist what pathway that would take So I ended up going and getting my undergrad in exercise science After receiving my undergrad I transitioned to Johns Hopkins Started working as a research coordinator and interventional pulmonology Got my MBA at Johns Hopkins transitioned to a more like clinical research network position really Helping the administrative side to develop clinical research trials, uh, for therapeutics, for medical devices and for diagnostics. Um, and it was during this time that I went to a Johns Hopkins Tech Ventures. Meeting and, uh, and there's the tech transfer office for Johns Hopkins. So the office where faculty members will go in, uh, and receive support, protecting technologies through, you know, getting technologies patented, licensing out technologies or starting companies. And I went to that meeting and I heard a gentleman share about a technology. He developed that he felt like good. could really impact patients, potentially save lives. But as it stood, he felt like this technology would just be in some high impact journals, would just really live within the research realm. Um, and that, that purpose kind of, you know, I heard that purpose from him for serving others. And, uh, and I approached him after that meeting. That was Dr. Steve Meltzer, my co founder. He's a GI physician, uh, researcher at Johns Hopkins. Um, and we spoke about this technology he developed for patients with the pre malignant condition, Barrett's esophagus, um, and for detecting and preventing esophageal cancer about methylation biomarkers and make it actually started off as a free internship. I said to him, Hey I don't know much about this condition. I don't know much about methylation, but you know, I'm interested in entrepreneurship. I want to serve, I want to serve others. Maybe I can do some customer discovery. And that's what really sparked off our, uh, our relationship. And we started meeting regularly and several months later, we, uh. Uh, we realized, wait this might really be an opportunity for us to get something out there. And that was the start of Previse.

Meg Sinclair: 5:06

What a cool journey that's been for you, um, from Camp Pendleton all the way to Johns Hopkins, from unpaid internship to CEO now. That's incredible. Um, how does Previse differentiate itself in the field of cancer detection, particularly with your ESO predict test?

Dan Lunz: 5:26

Yeah. So, so, um, we're really focused on the prevention side. So there's a lot of wonderful technologies coming out. And, uh, you've heard of like a multi cancer, early detection tests and blood tests for detecting early cancer. Um, there's a issue when it comes to esophageal cancer. And that's that even if found local, even if it's stage one disease, the five year survival rate is 47%. So even if you find it at the earliest stages, um, it's oftentimes already too late. So for esophageal cancer, there is this what's believed to be obligate precursor called Barrett's esophagus. And Barrett's esophagus occurs in about 10 to 15 percent of patients with chronic acid reflux or chronic GERD. And, uh, so there's a large number of, individuals in the United States who have Barrett's esophagus and it's this metaplastic change that'll occur. It's really quite incredible this change that the body will make where the lower esophagus goes from being like your skin, this squamous epithelium. to columnar cells, which is more like your, uh, your stomach or your intestines, which handles acid much better. Uh, the issue is that it puts you at risk for developing esophageal cancer. It increases the likelihood, um, as much as 55 times. for developing esophageal cancer. So when a patient is diagnosed via endoscopy with Barrett's esophagus, they're put on a surveillance program, oftentimes a lifetime surveillance program, to determine which patients are likely to progress to esophageal cancer. Um, now these samples are taken, these biopsy samples are taken, pathology reviews them, and they say whether they see any abnormality called dysplasia. Um, so what our test is able to do is to take that standard of care biopsy sample, we only need one of the biopsy samples, we take a few slices off of that block, we analyze it, we look at DNA methylation of four specific genes, we run it through our algorithm, and we're able to produce a five year risk score. Uh, for that patient. So personalized information for that physician. So we're the first and only DNA test, uh, for Barrett's esophagus prognosis. Um, and it's been wonderful to see the impact it's already making in the clinic of GI practices.

Meg Sinclair: 7:53

How widely distributed is it being used in GI practices in

Dan Lunz: 7:57

the States? Yeah, so, so, so we, uh, I'll tell you what, do you mind if I don't go far down that path?

Meg Sinclair: 8:07

Sure, yeah. Alright. Sorry. That was an ad lib question. I'm sorry.

Dan Lunz: 8:11

It was, no, Meg, it was such a good question, but it's funny because I we're fundraising and we're, uh, so maybe we can say it. Let me not throw numbers out there.

Meg Sinclair: 8:23

Yeah, maybe, can I reframe the question of like, how big has your impact been so far in the GI space? Yeah,

Dan Lunz: 8:32

yeah,

Meg Sinclair: 8:32

let's do it. Okay. So far, this sounds amazing, this technology, how wide has your impact been in the GI space so

Dan Lunz: 8:39

far? Yeah, so it's been wonderful to see the, uh, the adoption and really the rapid adoption in the clinic. Um, we have a number of academic sites and, uh, and community clinics who have adopted this technology. One of the really cool emails we just received last week from the GI physician shared about a patient that they had who had Familial history. They had a brother who had esophageal cancer and this patient had this precancerous barrett's esophagus and the physician was trying to determine what to do with this patient. Do we keep him on a surveillance program? Do we consider treatment? At what frequency do we do surveillance? If we stay with surveillance? Um, so they ordered our ESO predict test and they received a higher risk score. It showed that this patient had a higher likelihood for developing esophageal cancer in the next five years. Um, so they actually moved forward, spoke with the patient about it and determined that ablation was the best pathway forward. So they were able to move forward with that endoscopic treatment. It's an ambulatory treatment. They're able to do, uh, uh, in the endoscopy clinic. Um, and potentially it's another cancer prevented.

Meg Sinclair: 9:53

That's amazing. That's such great impact and great to see such a great adoption on a new technology. Sometimes that's a difficult hurdle for new and emerging technologies to have the value propositions and have clinics and hospitals pick up their technology. But that's amazing. The traction you guys have gotten already. That's great.

Dan Lunz: 10:11

Oh, thank you.

Meg Sinclair: 10:13

Um, many founders on our show have interesting stories about fundraising. Can you share any fundraising experience you've had recently and how you've worked to raise funds to bring your products to market?

Dan Lunz: 10:24

Yeah. So, so, uh, so fundraising journey wise, you know, it's, uh, it's funny cause I think back to our first investor that came on, it was an angel investor and a successful entrepreneur who, uh, who himself was facing. cancer. He had a stage four cancer diagnosis. Um, and about five minutes after him, after I met him, um, he said, I'm gonna, I'm gonna invest in your company. And, uh, and it was really altruistic. And he took a flyer. On us and, uh, and things have progressed and changed a bit since that first check that came in. Um, so, so we are currently fundraising, um, and what we're really focused now on is the pathway to more market adoption. Uh, so commercial activities and then what's called market access and our reimbursement strategy, how we're going to, how we're going to. Uh, achieve what's called local coverage determination with Medicare and with private payers as well. So it's, uh, so our story has really transitioned from the early altruistic days of, Hey, this is something that could potentially save lives to now saying, Okay, this is how we're actually going to execute on this strategy.

Meg Sinclair: 11:36

Yeah, such an important piece of that puzzle, getting the payers to pay for it for the product. Oh, yeah, the patients want it, but the payers have to pay for it to make it happen, right? Um, wonderful. Are there plans to expand Previse's technology to other forms of

Dan Lunz: 11:53

cancer? Yeah, so, so we, uh, we're taking a broader view both with oncology cancer and then also with other upper GI conditions. So, uh, so one of the things that, that we've been really fortunate with is, uh, is receiving, uh, non dilutive funding as well. So there's these NIH grants called SBIR, Small Business Innovative Research Grants. Um, so we just received the 1. 8 million grant, uh, to conduct further studies, uh, with our ESOPREDICT test. But also we've been fortunate to receive NIH grant funding for our pipeline technologies. And then one of the, uh, one of the things that we're looking at is how can we do this non endoscopically? So we started off with endoscopy and these biopsy samples and risk stratifying patients, but it still requires an endoscopy. And there's another issue, which is the detection. of that Barrett's esophagus. So we, uh, we have a, uh, we call it a sponge on a string device that we've developed, which the patient swallows a capsule, sits in the stomach for five minutes, and it has a string we're able to, uh, uh, pull, or I'm sorry, the capsule reveals the sponge. We're able to pull the sponge out via a string. It's a five minute procedure, a really painless procedure for the patient. But from that, we're able to analyze, uh, DNA and other markers, and we're evaluating, uh, uh, early detection of Barrett's esophagus and the two primary types of esophageal cancer, adenocarcinoma and squamous cell. Um, one of the things that I think is really exciting is that through these NIH funded studies, we're doing work here in The United States at multiple sites, also in Europe. Um, and then also in East Africa and lower and moderate income countries such as Uganda and Tanzania, where we're squamous cell carcinoma is one of the leading causes of mortality and men. Um, so, so looking at how do we touch patients along this journey? And then we're also evaluating other conditions such as, uh, stomach cancer and throat cancer as well.

Meg Sinclair: 14:00

That's amazing. Um, seems like a lot of applications and lots of cancers that can be prevented through your technology. Um, great. Is there anything else we can expect in terms of new developments or new tests in the near future from Previse?

Dan Lunz: 14:19

Yeah, so we have some exciting announcements that will be coming out this year, uh, uh, publications for ESO predicts, but also for our pipeline technologies and some news that will be coming out about our medical device. Um, also about our assays and tests in development. Um, so, so it's 2024 is a really exciting year for us.

Meg Sinclair: 14:40

Well, I will be staying tuned for all that exciting news from Previse. At, here at Qualio, we provide an eQMS software. Um, so quality is always near and dear to our hearts, mine especially. Um, but most founders don't have a quality or regulatory background when they start and can get caught off guard with regulations. Um, as Such in the medical device industry. So we like to ask founders like yourself about your journey through the quality and regulatory landscape and how you've navigated that, getting your product to market.

Dan Lunz: 15:10

Yeah, so, so when we started, no and a really important question. And, uh, and you know, when I started when we started Provise, um, it was something that I knew. Really nothing about. We saw this cool technology that we felt like could make an impact with patients. Um, and it was all of those reasons we were diving in. And I remember, uh, speaking to a founder of, uh, of another diagnostics company here in Baltimore, and they told me about a CLIA lab. And, uh, and I had never heard this term before, so I remember going home, running home and Googling and trying to learn everything I could about a Clio lab. And, uh, and I remember, Meg, it was funny we started and actually, uh, one of the team members who helped us, uh, develop our Clio lab. One of the first discussions I had with her when we were first thinking about getting this company going was, hey, what is this Clio lab? They speak of so so so you hit the nail on the head when you talked about founders who don't have experience in that regulatory realm, very important realm. Um, so, so we were able to bring on the proper support to develop our CLIA lab, um, and to undergo, uh, developing SOPs, our quality management. Systems, quality controls and get those in place and beyond clinical validation, which is what we often think about in the academic universe, diving in with the analytical validation and how do we take this cool data and good data that we may have seen in the academic realm in a research lab and how do we transition that into a clinical lab where you might be doing a large volume of testing per day in different patients And ensuring that you're getting consistent, uh, results that you can trust for those patients. Um, and it was quite a journey learning about it. So, so, uh, uh, I'm grateful to share that, that, you know, we were able to bring on the proper expertise. I learned a whole lot more and I got a wonderful, uh, uh, group around me, a team around me, uh, that's been able to Uh, you so predict validation studies analytically and clinical validation studies and put our Q. M. S. Systems in place. So we've gone through our clear compliance, uh, inspections and being able to get clear in all states. Uh, not New York state yet, but in all other states. Um, so we're launching as a laboratory developed test. So really pleased with where we've been able to get with that.

Meg Sinclair: 17:47

Amazing journey from what is this clear to throwing out all the acronyms like Q. M. S. F. D. A. Party 20. All of that. So lovely to see that journey from a CEO and founder, um, related to quality and innovation. How does provide strike a balance between pushing the boundaries of medical technology and ensuring compliance with those

Dan Lunz: 18:09

regulatory standards? Yeah, no, and this is a, uh, it's a really good question because there are there, there are universes, you know, when you think of innovation and when you think of developing a consistent high quality performing test, uh, it's sometimes hard to connect that, you know, in the research around when we're looking at innovating, um, you might be modifying your procedures regularly. You might be, you know, you're doing DNA extraction one way. Okay. And you learn about a different protocol, or you modify the temperatures a little bit, or whatever it may be, uh, the time that it's sitting in, some kind of solution, um, and you say, okay, hey let's make this change. This works better. And you're constantly innovating and optimizing. And, uh, and, you know, if I can dare to say, uh, uh, toying around. A little bit, and it's really about okay, demonstrating in early biomarker discovery and validation that, hey, this works. Look, we've got good what's called area under the curves or sensitivity and specificity in this limited case control setting, um, but it's, you know, and getting that next research paper published and showing the innovation and maybe going for grant funding for that innovation. Um. Whereas in the clinical lab, uh, you know, I heard a founder of a, of another company here in Baltimore diagnostics company who shared that one of the toughest things for him. He's a PhD scientist. He shared that one of the toughest things for him was to come to that place where he had to release control. And had to let kind of his baby, if you will, something he had been, you know, working on for years and investing so much time and, uh, and coming to a place where, okay, it's time to release it so that now it can go into that next step into product development and being developed into a clinically usable. Product, um, so, one of the things that, uh, that we found is the earlier that we can get involved, be involved with technologies that are just being invented or assays that are just being discovered the better so that we can start putting into place some analytical testing, start looking at, okay, how will this really translate into the clinical realm? You know, uh, how do we start to lock down procedures and just to have wonderful interactions with people on the research side and on the discovery side and people in, uh, in the clinical lab that are more on the regulatory side. So I think one of the keys for success that for us, at least, is the earlier is the better and the clear communication. Um, and then that's really been a key for us.

Meg Sinclair: 21:06

Thanks for sharing that. That's a great, that's great advice. I think for the starting out trying to find that balance earlier is better to bring in the quality and strike that balance. Um, so we talked about kind of new things coming in the near future. Do you see, um, any long term goals around cancer detection and provides that you want to share in the next 5 to 10 years, big dreams for the organization.

Dan Lunz: 21:29

Yeah, so, so really focused right now on getting ESO predict out there and how can we impact more lives? How can we, uh, increase adoption, make it more accessible for patients? So, like we talked about, uh, that's on the commercial front, but also on the reimbursement front and getting coverage becoming in network test. Um, with different payers. Um, and then along with that, looking for different avenues that we can bring other clinically relevant and important tests to market that are, uh, that are going to make a difference in patient care. You know, we talked about the multi cancer early detection, but I think one of the things that, uh, That has been really interesting to see in the past couple years is a return by a lot of companies to focusing more so on specific cancers or specific indication. You're seeing a lot of, uh, minimal, uh, residual disease testing focused on, you know, starting off with a specific cancer, whether it be colon cancer, lung cancer. Um, and what we find is in the regulatory front, you know, the FDA front on the payer front, uh, it's currently more so built. Our system is more so built for that. So it'll be wonderful to see not only the innovation from companies like provides, but also as we go through and the FDA continues to try to, uh, iterate and innovate and as payers try to come around and, uh, and develop pathways for getting the necessary clinical analytical control. Uh, validation data and clinical utility data. So I think it's really, uh, going to be quite wonderful to see, uh, us as an ecosystem moving in that direction over the next 5 10 years.

Meg Sinclair: 23:08

I hope the healthcare system

Dan Lunz: 23:10

moves that quickly.

Meg Sinclair: 23:12

I'm hopeful. I'm hopeful. Um, our last question is more of a fun one. We love to ask each of our guests at the end of the show, if we ran into you at the bookstore or at your local library, Dan, in what section would we find you?

Dan Lunz: 23:27

So, so I am a big history buff and I love biographies. Um, so I've done deep dives on Benjamin Franklin and, uh, and different Walter Isakson, um, biographies. So I, I start a lot of biographies. I don't finish as many as I start, but very likely that's where you'd find me.

Meg Sinclair: 23:52

Okay. Wonderful. Well, thanks so much for sharing.

Dan Lunz: 23:56

What about you? Oh,

Meg Sinclair: 23:58

I also am a big biography buff. I always like reading about people's lives. Um, And the one on my bookshelf right now is Hedy Lamarr, an actress and innovator. So, um, I'm saving that one for my March women's history read. So, but probably the same history and biographies are my thing these days.

Dan Lunz: 24:18

Awesome. And I'll have to pick that book up.

Meg Sinclair: 24:21

Yeah, I'll send it over to you. Um, for our folks wanting to learn more about Previse and yourself, where can they go along to follow along on your progress?

Dan Lunz: 24:30

Yeah, please check us out at Previsedx, like diagnostics. com. Um, you can also look us up on LinkedIn, Prevised Diagnostics, um, or me, you'll see me on LinkedIn, Daniel Lunz, and please connect with me.

Meg Sinclair: 24:46

Perfect. Yeah, we'll post all those in the show notes and we'll get connected and I'll send you that biography on Hedy Lamarr.

Dan Lunz: 24:53

Awesome. Thank you so much, Meg.

24:56

Thank you for listening to this week's episode of From Lab to Launch, brought to you by Qualio. If you like what you've heard, please subscribe and give the show a positive review. It really helps us out. For more information about Qualio, our guest today, or to be a guest on a future episode, please refer to the show notes. Until next time.