- I mean, the negative impact of this cancer is profound, as you started the conversation off with. We don't want to stop at one option or two options, or even three options. We have got to, as a scientific community and as a public health community, keep coming at this problem from every possible direction with every possible solution. There are just too many people at risk that are not willing to get screened or don't know that they need to get screened. And then they just... We need options. We need everything possible out there.

- [Narrator] You're listening to "Further Together", the ORAU Podcast. Join Michael Holtz and his guests for conversations about all things ORAU. They'll talk about ORAU storied history, our impact on an ever-changing world, our innovative, scientific and technical solutions for our customers, and our commitment to the communities where we do business. Welcome to "Further Together", the ORAU Podcast.

- Welcome to "Further Together", the ORAU Podcast. As ever, it is me, your host, Michael Holtz from the Communications and Marketing Department at ORAU, and it is Colorectal Cancer Awareness Month. As a colorectal cancer survivor myself, this would be the high holy days of cancer awareness for me, and I am thrilled to have a couple of friends with me on the podcast this episode, talking about new technology and new detection methods for colorectal cancer and other cancers. My friends, Eric Meyer and Jessica Ethridge from New Day Diagnostics are with me. Eric and Jessica, welcome so much for being here.

- Oh, well, thank you for having us, Michael. It's a pleasure.

- It's great to be here.

- I'm so excited to be talking to you. We've known each other for a few years through a name change of the company or two, whatever, but there are exciting days ahead for early detection and prevention of cancer. New Day is on the front lines of that, and hopefully we get to talk about a little bit of what's going on. But first, Eric, if you would talk about what New Day Diagnostics is.

- No, that's a great question. New Day Diagnostics is a cancer diagnostics company. We believe wholeheartedly that if you catch diseases early, there's a bright New Day ahead of you, thus the name. We wanna empower patients with more accessible options, starting with colorectal cancer screening. We can find this disease earlier and get the correct patients to go to a confirmatory colonoscopy or get the correct patients into a treatment if they need it, and give that physician and that individual an empowering tool that they don't currently have, or a new option that they don't currently have. New Day as a company has a deep history in colorectal cancer research and research in other disease areas. We have a pipeline, a robust pipeline of other diagnostics in oncology, in infectious disease, in moving into women's health and in digestive disease. The goal is to get as close to the patient as you can and make sure that there are great options for those individuals to live healthier lives.

- I love it. And of course, if you detect cancer earlier, treatment is easier. You actually live and live longer. All of those great things. So I love, love, love what New Day is doing and what you all stand for. And I'm actually... I understand that when I was diagnosed, I was part of an early research trial, I guess, of the blood test 'cause my sample was used in the early days of the development of your blood tests. So that's also exciting.

- That's absolutely correct. Michael, you kind of introduced that we've known each other as people for the last few years, but we actually knew you as a number. We didn't know it was you, but as a blood tube sample for sitting in the freezer about 10, 12 years ago. And these things take a long time to research, to develop, to go through the clinical studies, to prove safety, to prove effectiveness. And we are on the cutting edge, but that started 10 plus years ago to get to this point.

- Absolutely, and it's really exciting and so necessary. I mean, the numbers, the latest statistics are on colorectal cancer are alarming and astounding, right? I mean, when you think about the fact that colorectal cancer is the number one cancer killer of people under the age of 50, under the age of 50, colorectal cancer used to be an old person's disease. That's not true anymore. Sorry, I should correct that. It's the number one cancer killer of men under the age of 50. Number two among women. But on the fast track to be really the number one cancer killer overall. We have been talking about in cancer advocacy world, the number one cancer killer of people under 50 by 2030. But here we are, it's 2024. It's happening much faster than even experts have predicted. So it's a little scary out there.

- It's happening here in the United States with younger and younger individuals. It's happening globally as lifestyles and diets change. Even in developing nations, they're seeing high incidents of colorectal cancer continuing to spike. And you're absolutely right. Right now the guidelines for screening are to start at 45. Used to start at 50. And we're very pleased and happy that the needle is moving earlier and earlier. That said, folks that are... I just turned 40. I had a colonoscopy performed three years ago. I do have family history of many cancers on my mom's side of the family. I know early detection is how you get ahead of these things, but I was not in the screening guidelines. That procedure was not reimbursed. I had to pay for that out of pocket. And folks that are our age need an option. They need something they can do effectively, efficiently, and that they'll do every year so that we could catch something as early as possible.

- Absolutely. And not be gaslighted, right? About your symptoms could be this or it could be that. And just do the screening test, whatever that is. Hopefully it's eventually a blood test that makes it easy. But do the test so that we can at least, at the very least, rule it out.

- Yeah, you're absolutely right. This is a cancer that grows fairly slowly over time. By the time you have symptoms, it's already in typically later stage. And that's not always the first thing that a primary care doc is gonna think. They're gonna think, let's look at IBS, let's look at IBD, let's look at other reasons that you may be having gastro symptoms. And those kinds of things in our opinion are standard of care. That's exactly what the physician should be doing. But if we can have a better option earlier, and it's not a hope anymore. It's happening right now. The New Day blood test, ColoHealth, is launching in March for Colorectal Cancer Awareness Month. So this will be accessible to patients and individuals by the end of the month.

- That is exciting. I love hearing that. And it's kind of breaking news-ish.

- This is the first announcement.

- So that's exciting. Eric, how long has it taken to get here? I know you've mentioned years, but I mean, it's clearly been over a decade, 12 years in the works to get here.

- It has been, and and prior to that, the company that started in Knoxville was called EDP Biotech, Early Detection Products. That company was founded in 2005. So we're going on nearly 20 years of underlying primary research. I came to the company in 2015, so almost 10 years of moving the direction of going from research into development, into clinical practice very soon here.

- So how did you get to become part of EDP and now New Day?

- Well, personally, it was a bit of an accident. I came from Raleigh, North Carolina. I was in cancer research at UNC Chapel Hill at the Lineberger Comprehensive Cancer Center. I did my undergraduate research there, went into diagnostics in Research Triangle Park. And then my wife, girlfriend at the time, wife now, got an opportunity at the University of Tennessee Knoxville, go Vals. And we packed up and moved to Knoxville, Tennessee in 2011. I met the company founder here at EDP Biotech within the first week of boots on the ground in Tennessee. The gentleman had started the cancer research company in '05, had spun out a veterinary genetics company in '08. And I actually started working on both right away and just continued my journey since then.

- Awesome, and then our paths crossed five or six years ago. It's been a minute for sure.

- Slept a few nights since then.

- That's exactly right. But it's been exciting to follow and watch the progress and especially as great work is being done to make these tests more accessible, easier to do. We know people love that colonoscopy, right? They hear the nightmares about the prep and they don't wanna... They don't want to have to endure that. And while prep has certainly gotten easier, the easier choice isn't a choice that everyone gets, at least not yet. And it's still an invasive procedure and a blood test is definitely much, much easier to do. So the easier we can make it, the more accessible we can make those tests, the more-

- And that's our philosophy.

- Right?

- Absolutely. The best screener is one that somebody will take and colonoscopy is the gold standard. It will remain the gold standard. A trained physician with his two eyes will find small masses and small polyps and colorectal cancers and then can begin treatment. Our job is to raise the red flag in early screening and say these are the people that need to go to colonoscopy. And that's exactly the way we're gonna create that accessibility and drive better patient outcomes, reduce mortality, reduce incidence rates, is by finding those polyps in their earliest state, sending those patients to confirmatory colonoscopy where the physician can resect and cut those polyps out before they progress to cancer. This is a preventable cancer, one of the few preventable cancers. So let's get on the forefront of it.

- Absolutely, and if we detect it early, if we get folks taken care of early, it's less expensive. More people live, all of those things. I, as you know, spend a lot of time in the cancer community with other advocates and other cancer survivors. And in my experience, I was lucky. I mean, I was diagnosed at 43. I did first line treatment. First line treatment works. I was diagnosed stage three B rectal cancer and first line treatment worked for me. But I know so many people who they're incurable. They'll be doing chemo for the rest of their lives, whatever that looks like. And if we can avoid that with a simple blood test with catching it early so that it's not progressed and at a younger age. If we can give these tests to people in their 20s and their 30s so that they don't have to endure long treatments and 144 chemo sessions and all of that. I mean, it's the quality of life and the quantity of life and the expense that can be spared if we can get this thing under control.

- That's right. We always think of cancers in general as very complex biological systems. There's never gonna be one single magic bullet cure. These are many diseases by many different genetic and environmental and behavioral factors that cause them in many different organs. So we wanna focus on the one that we believe is gonna make the biggest impact to start off, as you said, with the colorectal cancer incidences rising in certain populations. Here in the Appalachia region of Tennessee, we have higher than the rest of the United States incidents of colorectal cancer. And there's data showing that this annual blood test, this specific annual blood test when done annually, averts more CRC cases and averts more CRC deaths per 1,000 people screened than other modalities. So as a screening tool, we believe this is gonna make a humongous human impact and the economic impact that follows as healthcare costs are rising, let's figure out how to get those down. A simple cost-effective blood test is one such solution.

- That's amazing. It really is. In terms of, of course, insurance drives everything in coverage, what do people need to know about coverage for the test?

- So right now we are working on coverage. It is gonna be an out-of-pocket, but we wanted to make the out-of-pocket pay acceptable to most people. So we are going to launch this test at $199 to start off. We know there are other blood tests out there that are $500 to a $1,000. Those are not, in our opinion, accessible to most patients. But we are working with private payers, the Medicare, Medicaid, there is a CPT code. We're working to get that reinstated. So hang with us a couple more months. Hopefully we'll have the coverage. But to start off, to get this out to the patient population that needs it here in the Appalachia and in the sort of the Knoxville and regional Nashville, Atlanta, Charlotte, et cetera, the southeast region, we're gonna start off here in March under the self-pay model.

- Gotcha. For those of us who are cancer advocates and spend a lot of time working on policy, which I have spent years, what can we do to help get this test covered and make sure that it's truly accessible to everyone.

- Well, I will turn that over to Jessica. She just spent the most of this week in Nashville on Day on the Hill with Life Science Tennessee meeting with policymakers and legislators.

- Yeah, it was a really interesting experience. It was very impactful to sit down and talk with the legislators, one after the other with a group of us from Life Science Tennessee, just highlighting the bills that were coming through that were related to the work that we were doing. And so early diagnosis is a really big one. Just bringing it to their awareness that these are things that we're doing in Tennessee. We're developing tests to diagnose things earlier, to identify them earlier, and pointing out where the possible funding issues are or things with Medicare and Medicaid. I think that the cutoff for sensitivity? The sensitivity is we are where we are right now is just beneath the threshold, just beneath it for what their standard acceptability is in terms of what they'll cover. Maybe advocating for more due diligence and whether or not that is the number to be at. Diagnostics are a... Diagnostics are a place where we can really, really, really make an impact in disease. We're catching it before it's needing cures, it's needing treatment. And I think just generally having the awareness to our lawmakers that the diagnostic space is one to be paying attention to, supporting and advocating for on all fronts is really where we need to be having the conversation to begin with.

- Awesome. Well, I know for patients like me, if there's anything I can do to raise my voice, to help make any of that happen, I'm happy to do it. I have no doubt there are others that I can bring to the table as well. I just believe in my heart and soul that early detection and prevention is critical. I know too many people who have passed away, who are fighting this long term. And all of that is unacceptable, personally unacceptable to me. It shouldn't be that way in the world that we're living in today. So the fact that there is a test that is epically beneficial, that can catch this early, that can save lives, is incredibly heartening and I think will be exciting for a lot of people to learn about. So I look forward to you learning more and seeing results as things move along and as the test becomes available to folks.

- That's right. We're starting right here in our hometown of Knoxville, Tennessee. We're expanding out regionally in the southeast and then we are also working with several partners nationwide. Can't mention any names yet. But over the next six to 12 months, this will be available throughout the United States. And you and Jessica perfectly hit the nail on the head. There is a disconnect I think at the federal level. When the FDA approves something and says, yes, this is safe, yes, this is effective, this works, it's FDA approved. But yet we cannot create accessibility by allowing individuals to actually get reimbursed for taking the screening test. That is an unfortunate disconnect that we need to work on together with the advocacy groups and let's just keep pushing for early detection. We know that's gonna save people's lives.

- Absolutely.

- Absolutely. Well, again, wherever I can help, wherever I can bring folks to the table, I'm happy to do that because accessibility's important. We know that there are certain populations, black and brown people who are disproportionately at higher risk, and particularly higher risk of death from colorectal cancer. But they also don't have the same level of accessibility to the gold standard colonoscopy. So whatever we can do to level the playing field, and this test does that. It levels the playing field and can get into the hands of everybody, then let's do everything we can to make that happen.

- Well, Michael, this right here helps. This is awareness. This sends the message out. Jessica's been working diligently on our awareness campaigns that'll go direct to consumer, as well as to physicians and providers. So stay tuned. The month of March, we're gonna get a lot of info out. And that's the whole goal. If we can raise awareness so that individuals out there know to advocate for themselves, even when they go into their annual physical, "Hey, let's talk about this." This is not something that we should be embarrassed to talk about just 'cause it's our rear ends, you know?

- Absolutely.

- Let's get that awareness out and yeah, keep an eye out. We got to meet the patient where they are. So social media campaigns Jessica's promoting, we're gonna be on Facebook, we're gonna be on LinkedIn, we're gonna be where the patients go to get the information.

- You touch on an important point 'cause there is such a stigma around colorectal cancer and the body parts that are involved. Right? We don't like to talk about the fact that literally everybody poops. Everybody. We all do. We all have butts, we all have colons, we all have rectums. Mine looks a little different now because I have a permanent colostomy, but it still works just the same way everyone else's does. But there's this inherent fear and embarrassment of talking about what happens in the bathroom. And we need to get over that. We need to be able to say there's blood in my stool. I'm not feeling well, I'm bloated, I have cramps, I have... And a lot of those symptoms are signs of late stage diagnosis unfortunately. But we need to be able to talk about the fact that there's stuff going on in our bodies that we're not gonna be aware of. And if getting a blood test makes you live longer because you're detecting something early, by all means, let's make that happen. But I think again, we have to stop being ashamed of talking about what happens.

- And hopefully-

- In our underwear areas, as they say.

- Yeah, hopefully really even just having another option. Blood test as an option makes the conversation more approachable. What we are seeing in a lot of research out there is just for patients to have multiple options in ways that they can test and screen opens them up to the possibility. And I think this idea even lends itself to what you're saying about having uncomfortable discussions. Maybe it's easier for me to go into my doctor and say I'm having stomach problems and I noticed there was a blood test for colorectal cancer screening. It's just an easier conversation than this really overwhelming idea. We hear so many difficult stories about the colonoscopy and we know there's other alternatives that... But they also involve stool. So we're still... That's still involving these uncomfortable conversations and these uncomfortable body parts and whatnot. Maybe those tests are still the best one. Your physician might still say, "No, I think you need to do this test, or I think you need to do the colonoscopy." But if the knowledge that there's an option that they're comfortable with at least starts the discussion, then something like this begins to help the landscape in softer ways. Not just having an option that it's more accessible in so many ways. Geography, you don't have to be close to big facilities. More comfortable with the idea of donating blood. It can be done every year. You could potentially make it part of screening for younger and younger people. There's a lot, a lot, a lot of opportunities with this, but some of them are things that are soft like we're talking about here, just the conversation.

- And we make some jokes every once in a while. It's okay to have some fun jokes and-

- Absolutely.

- What's the new one? We make everything ColoHealthy around here with ColoHealth.

- Yeah. ColoHealthy and you don't have to ship it in a box.

- Yeah. We're not gonna go there.

- I can't do the jokes. I'm the worst joke teller ever. I'm like, I'll just mess it up. Just forget I said that.

- Because stool is messy. We mess it up.

- That's right.

- That's right. Exactly. And on the one hand, the stigma's understandable, but on the other hand, it's like, this can save your life. So I love the idea of Jessica making it softer, making it a softer approach to say, let's do a blood test. And then if we have to move to confirmatory colonoscopy, then we have the more uncomfortable conversation. But let's start with just sitting on the couch, right? We can move elsewhere after that, right?

- That's right. And the doctor's gonna know the best route and they're gonna be able to take the information and the result and make the best decision for their patient and consult with their patient properly. And it's all about getting info out there. This is another tool in the toolbox. It's not the only tool and that's the whole goal. As Jessica said, more options gives that patient some comfort level that there is something I can do about these symptoms I'm feeling and it's not necessarily something that's gonna be gross or uncomfortable. There are other options out there. And that's the whole goal, create accessibility. If it's our test, great. If it's not our test, great. We want people to get screened. That's the whole goal.

- I mean the negative impact of this cancer is profound, as you started the conversation off with. We don't want to stop at one option or two options or even three options. We have got to, as a scientific community and as a public health community, keep coming at this problem from every possible direction with every possible solution. There are just too many people at risk that are not willing to get screened or don't know that they need to get screened. And then they just... We need options. We need everything possible out there.

- That is so well said.

- Yeah, someday we'll have that little star trek scanner and we'll be able do everything. But that's a couple 100 years in the future. So until then, we keep innovating and we keep iterating and we keep making improvements. Jessica mentioned the threshold level. FDA reviewed it and said safe and effective. Well, we're gonna make some improvements and we're actually working on those already in our laboratories and in our research facilities to get far above that threshold, an extra 10, 20% above that threshold if we can. So it's always about getting better results, getting better patient outcomes and making better tools for the patient and the physician.

- And not to jump backwards too much, but you just gave me a thought. You're making it clear that this is deemed safe and effective by the FDA, where the threshold cutoff that is not allowing it to be reimbursable is actually CMS. So the FDA and the CMS, their guidelines and their expectations, there's a little...

- A misalignment perhaps. A misalignment. Thank you. That's sort word that I was looking for. And so that could be a really important thing to identify and go after. Is this 1% or 2% difference between these two things is how many people are prevented from having a solution that they're comfortable with 'cause of this small misalignment when the test has been deemed safe and effective by the FDA.

- That sounds like a place where advocate voices-

- Hmm, interesting. See, that's why we have these conversations is raise awareness overall, right?

- That's right. So yeah, I think that we need to fix that misalignment and straighten that road a little bit. So I'll take that under advisement. How about that?

- I love it.

- Is there anything we have not talked about that you wanna make sure that we cover in this conversation?

- I would just say keep on the lookout, especially if you're here in sort of the east Tennessee region over the month of March. There's gonna be news stories, social media stories Keep your ear to the ground because this is coming in March, newdaydiagnostics.com, ColoHealth, right? ColoHealthdx.com. Is that the website? And let's make this happen.

- I love it.

- Yeah, there'll be lots of information. It should be published any day now on our website. Certainly you'll be able to follow us on our social media and find out more if you're interested in actually coming and getting screened with this test.

- Awesome, I'll post links and all that in the show notes so folks will be able to find it, who are listening and-

- Perfect.

- Hopefully they'll take you up on the test and get it done because it could... The life that you save could be your own, quite frankly.

- That's right.

- Exactly.

- Get the test done. Eric and Jessica, thank you so much for spending this time with me today. I really appreciate it and I look forward to letting people hear more about ColoHealth and hopefully getting tested. But I know it meets a specific desire for me to spread the word about awareness and early detection and prevention. So I'm so happy we can have this conversation.

- Well, thank you for having us. We always enjoy, Michael, our conversations with you and we will continue this one 'cause this one's really important.

- Absolutely.

- Absolutely. Thank you, Michael.

- Thank you.

- [Narrator] Thank you for listening to "Further Together", the ORAU podcast. To learn more about any of the topics discussed by our experts, visit www.oau.org. You can also find us on Facebook, Twitter, and LinkedIn @ORAU, and on Instagram at @ORAUTOGETHER. If you like "Further Together" the ORAU podcast, we would appreciate you giving us a review on your favorite podcast platform. Your reviews will help more people find the podcast.