Dr. Paul Lindberg is the Chief Medical Officer for Screening and Exact Sciences and Emeritus Professor of Medicine at Mayo Clinic. He is board certified in Gastroenterology and Hepatology. He is a member of the American Society for Clinical Investigation and Sigma Xi Research Honor Societies. In addition to cancer screening innovation, Dr. Lindberg's research interests include molecular epidemiology and chemoprevention agent development. He has received numerous awards and honors, and he has published more than 200 articles, commentaries, editorials, and book chapters. Dr. Lindberg has a medical degree from Mayo Clinic School of Medicine. Welcome. Thanks for that nice introduction, and thank you for allowing me to participate in this wonderful summit. I appreciate all the presentations that have already been provided and look forward to what's coming later on this afternoon. I do want to acknowledge that it was intentional. It was great to be included as part of the success sessions number one. So what I want to do is I want to just highlight some of the things that are going on at Exact Sciences, talk specifically about navigation support and some of the other surround support, if you will, and not so much about the test itself, which Exact Sciences delivers as multi-targets, dual DNA, or Cologuard, but really how can we provide additional input to patients to increase the engagement so that they can complete not just step one, but ideally steps one and two of the colorectal cancer screening process. So when I was working under one of my favorite mentors at Mayo Clinic, we often talked about there's a three-step equation to successful screening, and that involves test accuracy, test adherence, and test access. I'm going to focus mainly on that middle section, as T.R. and Whitney and others have talked about, you know, there is no detection without participation. So a lot of what I'm going to focus on is that adherence piece. One slide at the end just to highlight accuracy as another way to try to engage people in that initial step so they have the opportunity to go on to step two. This is my disclosure slide. It's a little bit different. What I'm going to talk about are experiments and outreach activities that Exact Sciences is conducting. This is not part of our standard clinically available service at every level. So please know that we are on a journey. We'd love to discuss and learn from you as we go through this as well. So a little bit about who we are. You may be familiar with Exact Sciences, but we are truly a mission-driven company. We are out to eradicate cancer and the suffering that it causes, not just for colorectal cancer, but for other cancer types as well. We found that we can do that better. As a matter of fact, we can only do that with committed key organizations and thought leaders so that we can all achieve our common goals together. You've seen some of these numbers before already this morning, but I want to just focus on the number to the far right of the slide, and that's 60 million unscreened. When you look at participation rates of eligible patients, you look at self-reported up-to-date with colorectal cancer screening, multiply that by U.S. Census data, it comes out to about 60 million people who should be screened who aren't up to date. The numbers are even more striking when you look at different age bands, that 45- to 49-year-old population, 20 percent participation based on some recent data. So we've got a lot of room for improvement, and again, I think as everybody is recognizing, there's not one single strategy or one single approach that's probably going to meet the needs of everyone, so we need to work together. Here's another U.S. map, but it's a little bit different data than what you've seen already this morning. This is screening participation rates at populations that are served by FQHCs. I want to just point out that nobody hits the 80 percent goal. Only one state reported data that achieved 60-plus percent screening participation, and 41 out of 50 states are below 50 percent. So we've, again, got a lot of work ahead of us, and again, by doing things differently, hopefully by doing things with a new approach, we can improve this map moving forward. So what about the role of navigation support? Why is this important? The Community Preventive Services Task Force has recognized that navigation matters. It particularly matters in populations that may be vulnerable or have been traditionally underserved. In a systematic review, excuse me, of 27 studies that the group looked at, they recognized that navigation support in and of itself increased screening adherence by about 12 to 14 percent. So navigation has a key role to play, and it may be particularly relevant to the groups that we're talking about today. This is a snapshot of the ExactSciences Navigation Service. So the idea from the outset with the multi-targets dual DNA test, or COLAGARD, was how can we allow patients not just access to a test, but also to make sure that we can support them through every step of the journey. So this has been in place. This comes with every test order, and it starts with patient onboarding. This is outreach through mail, through phone. There's a personalized approach that's being tested as well. So there's a live contact to try to get patients to understand, okay, why am I doing this? Then there are updates along the way. There's educational resources that are available through whatever medium that patient is interested in. Encouragement, reminders, you can call them whatever you want, but there are little nudges to try to get patients to complete their test if they haven't already. We provide those services 24-7, 365, in over 250 languages. The test results come back then to the provider. They can also go to the patient if that system is interested in that dual approach. And then the communications about what to do next and when to rescreen if that patient's initial test results are negative are part of the process as well. This is the – these are the data I should have mentioned on the last slide. In a comparison of a group that didn't get that navigation support to a group that did, we saw a 22 percent improvement in the group that had access to the navigation support. So again, bolstering our emphasis on providing robust services along that clock face. So in a study that was done a couple of years ago now, looking at almost 1.5 million Medicare patients to see what was the completion rate for the multi-target stool DNA test, the number was 67 percent. And this is a pretty nice number when you compare it to some of the other colorectal cancer screening options that are out there that are available, and we believe that much of this is related to the fact that the test is supported by all of the services that come with it. As Whitney pointed out, you know, this is a lifelong process. Maybe we can start – when patients are very young, we certainly should stay connected when they hit that screen-eligible age and when they're already in the process and they've completed at least one colorectal cancer screening test. So the navigation support doesn't stop after the first result. It continues on. For patients who have had a negative multi-target stool DNA test, they would be eligible to rescreen in three years. For patients who are in that scenario, when they have an order for that second test, the completion rate is 80 percent. So first-time users are more likely to complete a second time even than patients in the general population. The other pieces of the navigation program is that we try to continue to reach out. We continue to make contact over that three-year time period so that it's not a cold call. The comments about when to reach out, what type of messaging, we want to make sure that we are involved along that entire path and so it doesn't come up as a surprise when somebody is supposed to be screened again at three years. So what are we experimenting on? Well, first we want to improve the patient experience or enhance it as much as we can. So we've got a patient health portal now that's been registered – that has registered nearly a million patients. They can find their personalized resources through this portal. There's a kit return app that's a little bit more generalized information, but it's self-learning. Patients can get answers to their questions through that digital resource. There's live and mobile support, as I mentioned. Interestingly, 90 percent now of Coligard patients provide a cell phone number. Fifty percent have provided their email address. When we reach out to them through their preferred contact message, we see bumps of, you know, one to four percent just based on reaching them in the format that they have requested. So I think there's a lot of room to grow there. And I do want to point out that there's also an opportunity now for bulk orders. These are sort of the mailed out programs. These are health system initiated in large part. If there's somebody that hasn't been screened, those individuals are identified. They receive an order for a multi-target stool DNA test and they can avail themselves of these resources to support that experience and hopefully then complete it in a timely way. Well, how about other patient convenience? This is not all success. We tried a pilot where we had a service that would schedule pickup of the Coligard kit from a patient's home. Of about 59,000 individuals who were offered that opportunity, about 0.05 percent took advantage of it, 0.01 percent, excuse me. So that was not a barrier that needed addressing based on the experience that we had. So we've now turned our attention to focus on some different challenges. But we do know that the messaging, how we communicate with patients matters. Time of day, should it be and or or. These small little changes in the messaging help us do a better job of delivering the message so that patients can take action. Optimizing sample collection, we've got resources now that are embedded and easier to find with the kit. They're imprinted on the box so that patients don't have to go too far to find what they need. And we've also modified the actual components of the test so that patients have a longer window to collect their sample and return it to the lab. We're collaborating with health systems, you know, probably not surprising, but co-branding means something when you put a familiar name on the order or even on the materials that go out to the patient, they're more likely to respond. We've got dedicated teams who can help to identify who's eligible for screening within a defined population and send the reminders not just to the patients but also to the providers as well. We do have an on-site kit distribution model. The standard process is that there's an order and the kit is mailed. But if the clinician wants to talk to the patient about the kit demonstrated in the office, there's an opportunity to do that as well. And we've seen that, at least in some instances, that helps to increase engagement. Two last examples, well, last example here and then moving a little bit into health equity, we do have language support services, as I mentioned. And we asked a group of patients, what is your preferred language? And for those who identified Spanish as their preferred communication language, we offered education support, navigation support with Spanish-speaking individuals. And we saw a 9 percent increase in the adherence in that small population as well. So we're trying to extend on those initial learnings. We're working with multi-resident facilities. There's a prison system in Connecticut where we have now tried to meet the needs of that population who is in dire need of better colorectal cancer screening. We've figured out a way to get the kits to that population. And we're seeing good return, good engagement there as well, so much so that we're now extending that to six other states. And I want to touch on some of the grant funding. We've had the privilege of working with ASGE on the colorectal cancer screening project, but we've also got 26 other funded projects, 175,000 patients who would be impacted by these different projects across 12 states. And it's really through what we call our FOCUS program. FOCUS program is multidimensional. You can see in the third, sorry, fourth chevron here, address and reduce barriers to follow-up colonoscopy adherence. That's a major component to our commitment to health equity. So we hope we can do more of that moving forward with all of you and with other organizations. So lastly, one slide about accuracy of the test. Wanted to just highlight that, again, in order to get to the second step of colorectal cancer screening with a non-colonoscopy screening strategy, you have to get patients engaged in that first step. You have to have an accurate test. So we've just completed now and announced the top-tier results from a 20,000-person study. The goal here was to improve specificity primarily while we maintain the sensitivity of the test for both cancers and advanced precancerous lesions. We were able to do that. The specificity improvement with this next-generation test should reduce the number of colonoscopy referrals for false positives by about 30 percent. So more to come. We will publish and present these data as quickly as we can. There are still more steps, regulatory and others, before this makes it to the clinic. But wanted to make sure that you had at least this awareness so that as we move forward with, you know, phase two, phase three of the ASGE project and beyond, we hopefully will have even more opportunity to have a major impact on the lives of the patients that we're trying to serve. So with that, I'll stop, and thank you very much.

Dr. Paul Lindberg

navigation support

colorectal cancer screening

test adherence

test accuracy