“Very Cutting-Edge Trends in IVD” Webinar Video and Transcript

On December 4th, Eye On IVD consulted three IVD industry experts to talk about less than notable trends. We have received many requests for our webinar for those who were not able to make the live presentation or would like to re-hear it.

Please find below our Very Cutting-Edge Trends IVD Webinar in video and transcript format:

Webinar Participants:

Rob Lacroix, LTC LLC

Frank Criscione, Broadbranch Advisors

David Freestone, BridgeworX

Bruce Carlson, Eye On IVD

A transcript is available below. We note that it is an AI-generated sound transcript of the webinar, and thus there may be some imperfections; best to listen to the webinar video as well.

We’ve Done the Work For You. A Reminder about EYE ON IVD/Howe Sound’s Business Planning Tool – ARTIFICIAL INTELLIGENCE IN IVD MARKETS

Bruce Carlson: Hello and welcome to the webinar. This is EYE ON IVD’s Very Cutting-Edge Trends in IVD webinar. It’s very difficult to predict the future. And when you’re doing business planning, there’s a tendency you’re going to look at your competitors, you’re going to look at market opportunity, and things like that. The big issues and trends, trends discussed generally in in vitro diagnostics right now, like, you know, would be say, automation, say decentralization versus centralization and the use of genetic tests. But what about those trends that are a little bit below the surface? So we’re going to keep off some of those larger topics in in vitro diagnostics.

And my prediction would be that of the half dozen we’re going to discuss today, maybe, you know, 1 or 2 of them is going to you’re going to see in your business in the next 1 or 2 years or sooner.

I want to welcome the panel that I have. And the key to our panel is that they’re all folks who have helped companies and clients navigate the IVD market. We have Rob Lacroix from LTC, LLC with us. We have David Freestone from BridgeworX. He’s also formerly at Cue, Visby, and, Cepheid, so I’m looking forward to hearing some of his insights. And we have Frank Criscione from BroadBranch Advisors. If you attended our state of the IVD industry, which many of you may have, I was very well attended. You know, Frank already. So, Rob, why don’t we, why don’t we have you get started with smaller sample sizes?

SAMPLE SIZES AND BLOOD USAGE

Rob Lacroix (LTC LLC): All right. Thanks, Bruce. I appreciate the invitation. And just a quick thing about me. I’ve been in the industry for just about 20 years. 20 years next month, and nine of the last nine have been in the as a consultant. So smaller sample sizes. So this slide in all of my slides are going to be from a patient perspective. So when you think about patients, provide the samples. We obviously take those samples, analyze them and report the results to patients. And some sometimes I think the industry thinks, , those sample tubes have been kind of commoditized. You know, we think of it as a tube and not a patient. So how does the patient benefit from continued industry adherence to the Vacutainer sample tube standard?

The tubes have been around for a long time since 1947, and the IVD instrumentation is designed to accommodate the tubes really as their primary sampling point. But in reality, and this reality has been in place for decades, both the test and the instrumentation utilize only a fraction of the blood in those sample tubes. And the other thing is, that the instruments are designed to accept smaller sample containers in their operator’s guide, they’re often referred to as such, which you know can be made by the same sample, the two manufacturers. So every lab today has the built-in ability to utilize less patient blood without impacting test results. However, it would be a manual process to do that because most of them are automated to the tubes. The other thing to consider is historically smaller samples meant capillary sampling. Fingertip sampling in that process is historically it’s a manual process, and it hasn’t been the most reliable.

Rob Lacroix: But that’s changing because we have recent FDA-cleared devices that would allow labs to automate with smaller patient samples utilizing the current. So same, same capabilities, the result being the same tests and less blood. What you can see here on the slide, you can see that a couple of companies have recently gotten FDA approval for capillary sampling.

We have BD who invented the the Vacutainer back in 1947. They got their mini-draw approved earlier this year, and so they see the value in smaller sample sizes. I don’t think they’ll ever replace Vacutainers. They’re kind of ubiquitous, but the option is there. And they’re not the only ones. Another company that recently got approval was Reddrop with their RedDrop DX device. That device samples on mostly the upper arm, so it’s not even the fingertip. And both provide micro samples of about 500 microliters. And that can be for hematology testing, chemistry testing, immunoassay testing, coagulation, basically all the blood testing in the core lab.

So at the end of the day. All right, we can use less blood. Will we use less blood? Well, there is a lab using tier-one IVD instruments, the same ones that are available at Quest and LabCorp. So they are going to be doing the same tests with less blood. And as they go national, I think they will compete with Quest and LabCorp.

Bruce Carlson: Well, Rob, this is a great trend to note. Do you think like if we were having this conversation two years from now, this might this might be something more in the forefront?

Rob Lacroix: it definitely, could be. , you know, I don’t want to say it will be because I don’t want to jp the gun, but, I mean, the fact that you know, the backing here, you know, BD is, is actively Involved by, you know, providing a solution. But other players are involved. It’s, the company isn’t completely out there commercially, so I will not mention them, but they also have backing from other major IVDs. So the potential is there. And then you think about it obviously from a convenience standpoint for a patient, less blood is a big deal. And this isn’t like Elizabeth Holmes with a little a little container. This is happening. This is on the same instruments used by Quest and LabCorp. And as they get out there, they’re going to market it. And then think about it as doctors find out that they can get the same test with less blood. Aren’t they kind of obligated to potentially go that route? So yeah, I think this one this one has legs.

LAB-IN-A-BOX IS JUST ABOUT HERE

Bruce Carlson: This is a big one. You know we were just at a ADLM. I still call it ACC I can’t stop, ADM recently, and, you know that there’s some big, big news there in this area, you know, and a focus.

Rob Lacroix: Yeah. So, absolutely. So lab in a box. So let me start. This slide is full and it’s designed for multiple stakeholders. So there’s information here that would be valuable to a lab an OEM regulatory VC and a doctor. So this is a slide I know that you can revisit when the video becomes off when the presentation becomes available. And I encourage it because I am not going to be able to cover everything on this slide today. I’m not even going to attempt it. So let’s look at it again from the patient’s perspective. What does this do for the patient? So really the lab in a box is all about access convenience and knowledge. That’s what it gives the patient and a turnaround time of a significant amount of tests.

Realistically, it’ll max out at about 75. Roughly 55 blood 20 urine. And when you do a comparison and you look at it compared to the core lab from a visit standpoint, you’re getting this. All the patient’s getting this all done in one visit versus two. From a blood standpoint, you only need about two milliliters of blood versus 50 that you would get with the core lab today. Urine quarter of a cup of urine. And then the results the patient is getting the result because that’s really what turnaround time is.

What’s the turnaround time for the patient? They’re going to get results from the time the visit.

They take the blood sample and the urine sample when they’re sitting down, having the results reviewed with their doctor. You’re looking at about 60 minutes versus when you look at the standard in a core lab, you’re looking at a week plus. And of course, there’s a little asterisk there because that that week is the week after the second visit, after they’ve given the blood sample. It takes about a week to get results. So, you know, that’s just the reality for a patient with this. Okay. So you know I’m.

Bruce Carlson: I wanted to drill down on that a bit just to make it clear. And, you know, it could be, you know, it could be a non-important comment, but I, you know, that second, that 60 minutes means you’re now having the information related to you from the provider, from the doctor and what have you, the person who first assessed you. I don’t want to say that patients may not always give accurate information to the provider, and the blood test shows something different, but certainly it tests for that. you know, you’re often getting that call from the office staff, and they might have an instruction from the doctor or watch your cholesterol, but it’s never going to be as robust as the provider talking to you.

Rob Lacroix: Absolutely. And that nests very well into what does it do for the doctor. All right. So we’ve done something for the patient. Let’s let’s talk about what’s lab in a box for the doctor. Well, think about it’s convenient for the doctor because just as you said, they’re getting the results and they’re talking to the patient after seeing those results in the visit. So you can schedule next steps. , from a knowledge base, they’re passing that knowledge on, as you mentioned.

But there’s another thing here for the doctor. They get paid. And that’s completely different than sending when a doctor does a send-out test unless the instruments in their office don’t get paid. So they lose money on every send-out test because as part of the visit code, they need to review those tests and then follow up with the patient. They don’t get to say, okay, it’s 10:00 at night. I’ve reviewed the test. I can charge the patient 15 minutes for my review. No, you’ve already charged the patient for the visit and then you need to follow up. So when you think about the when you think about the amount of time that the doctor is spending and time is money, doctors can be losing per patient between 10 and $50 easily, especially if a patient has a couple of comorbidities. Now, think about that. How many patients do they see a day? How many a week? How many a year doctors are losing, you know, hundreds of thousands of dollars every year in their time reviewing tests? Whereas if they now have the lab in a box in their office, they would get paid for those tests.

Bruce Carlson: And it’s interesting that you say sizes range from a microwave to a refrigerator. I mean, those are very different. Those are very different sizes for systems. So it’s really the function that determines lab in a box. It doesn’t have to be a box.

Rob Lacroix: Right? One of the four startups has decided to kind of keep the instruments as modules separate. And that’s why it’s the size of a fridge. And that’s why that’s that’s noted there. But the other three that I’ve kind of got here and other ones that I’m aware of, they’ve basically put it all into one smaller footprint.

Bruce Carlson: Varying technologies and $700 million! You know, you have the little note there. For people in this industry -which IVD does get a certain amount of investment. It depends on what year. Sometimes where we’re, you know, rich with, VC capital and but that’s a, that’s a decent number for startups in IVD.

Rob Lacroix: Yeah. And so I’ll skip ahead a little bit here. I have a little note on that. So we’ve got there’s more than four but there are four leading right. So how many? This is IVD. This is the industry where bigger companies acquire smaller companies. That’s just what’s happened. And it’s happened for decades. How many potential buyers do you think there are for those four startups? I invited the president, CEO, or chairperson of all the companies I thought could buy those four today, and I ran out of fingers. I had to go to my toes. So there’s an opportunity here, not just for these four companies, but who’s ever behind them and who’s ever interested in investing.

There’s an opportunity here. And from a period, I’m on the record as saying, you know, I think that at least one of these companies will have FDA clearance by 2026, and I’m comfortable enough to say by 1 to 2, we’ll have it by ADM of 2026. They’ll be FDA-approved. I think they’re that close. I don’t have any inside knowledge of that. But that’s just from what I’m seeing. And if you think about it, there are also other potential players here. Think about retail, retail, and healthcare. You know, you hear all these stories about these big the biggest companies in the world getting involved. And then they they d p it off after a year or two because it’s not successful. If I’m a retailer and I have one of these systems, think about it. The customer goes online, orders their test, comes in, gets gets the sample drawn. 60 minutes later, they have the result. I’ve built I have the credit card on file. I think that’s a winning solution for retail and healthcare. Yeah, you don’t have to you know.

Bruce Carlson: So great point, great point.

Rob Lacroix: And finally, just one thing, because this is a long slide and I apologize to my fellow panelists. Think about this from the OEM perspective. The OEM gets paid for the test just like in a core lab, but they’re also the lab. So they get paid for the review, right? And if they’re if they’re going to they have the opportunity to do. I do think that’s all available to the OEM. And when you think about I, we’re all familiar with the Forssmann quote, 70% of medical decisions utilize lab testing.

Well, he continued on to say in that quote, that 70% correlate to 80% of the objective clinical data in a patient’s medical record. Objective clinical data. So the opportunities for AI here are huge for a company that’s also the lab.

Bruce Carlson: Oh I think that’s going to be a good lead into what we’re talking about in the future. But as tempting as it is to do that. Frank or David, do you have any comments, any thoughts on lab-in-a-box?

David Freestone: We’re working with probably one of the four that you’re thinking of. Rob. , and, you know, I agree with, with everything that Rob said that there’s of course, you know, other factors at play. , again, these, these huge panels that, that most of them are, you know, are targeting. How’s that going to be considered as far as reimbursement? And, you know, some of those things go because we’ve already kind of seen that in more of the molecular world and, and some of those type platforms. So there’s some, some marketed initiatives and objectives out there that, you know, it’ll still have to wait a little bit to be seen.

And then even though it is available in 60 minutes, can you get a patient to come in an hour before their appointment? Have their blood drawn and be able to have those results when they are in with the physician? you know, so there are some, some real standards to that care continue that are going to have to be modified and adjusted. But I do think that this is finally the technology that’s going to have the ability to maybe drive, you know, some of those changes and rethink how we are treating patients. , to take advantage of this kind of one-stop shop or, or, you know, “treat em and street em,” you know, all in the, in the same visit. Yeah.

Bruce Carlson: It’s fascinating. Potentially it leads into urgent care leads into retail. As Rob was saying, the retail healthcare is struggling. Retail clinics. I did a webinar on retail clinics in 2018. Retail clinics industry never reached that level. It’s they’ve had some success, particularly in the drugstores. but when you think about who can keep a patient occupied and come back, for a quick talk after the results are done and somewhere either in urgent care or the strip mall nearby or retail, that’s great.

Frank Criscione: There’s one thing I wanted to add coming from a research background, I do have to say lab in a box, I think is going to, you know, not revolutionize but push forward clinical trials. , if we think about, you know, access and the ability to quickly push someone through a clinical trial, get someone in, get someone out with the same type of, you know, tests and data acquisition that they’re going to go when they’re actually in the patient side. It’s only going to give us better data and better modeling for actually when we do put drugs through the system. So not only I do think that there is an application when it comes to diagnostics, but also in improving our drug development itself.

Rob Lacroix: Yeah, there’s a whole that’s a whole research use-only application built right in there. Yeah.

Bruce Carlson: Well, great. , I think then we’ll jp to Frank Criscione. We got a little preview of him there from Broad Branch Advisors to talk about AI, wearables, and clin data.

ABUNDANCE OF CLINICAL DATA, MADE USABLE BY AI, AND WHAT THAT MEANS?

Frank Criscione (Broad Branch Advisors): Bruce, thank you very much for the invitation. It’s great to be here. , I want to start the talk, of course, by saying I’m from Broad Branch Advisors. We function across a variety of industries. Particularly, I function as one of the subject matter experts for life sciences and clinical diagnostics. , and so this field in itself is, is exciting because this is what we do. We try and find those areas that are emerging, those areas that might be interesting in the future, and, those areas that with the right amount of investment, the right amount of attention could blossom.

But before we begin, I want to start with a little bit of a question: How much data do you think a provider or providers globally generated for patients, meaning clinical diagnostic data per day in 2023?. And don’t Google it. Just just a rough, rough ballpark. Are we thinking of gigabytes or megabytes? If anyone can remember megabytes what are we thinking?

Rob Lacroix: Per provider or in total?

Frank Criscione: . Total. Total per day.

Rob: Terabytes.

David: Oh, yeah. Terabytes. Say terabytes. Exactly.

Frank Criscione: Exactly. Terabytes. The 2023 number was 137TB of data per day. Wow. That is about 60 laptops of data per day. And so now you think about that again in 2024. The jury’s still out. We don’t know what that n ber is, but we know data acquisition is constantly going forward we keep generating more and more data. And this is what I’m calling, you know, the beautiful or good problem to have. So we look at this, you know, sort of scenario and say all right, we’re generating all this data. We know we’re only going to generate more. What’s driving that? Well, we have an aging population the longer people live, which is a great thing to, you know, to be seeing, the more data they’re going to generate. When it comes to clinical diagnostics, what also is happening? Providers. Everyone is testing for more robust types of tests, meaning they’re getting more data from the tests that they are performing. And so if you do a simple multiplication exercise, you’re going to start seeing that over time.

This data is just going to expand. And so when it comes to data you say all right 127. You know, there are 137TB of data. Do you think a single provider is going to be able to analyze all of that? Not. So we have a problem there. And that’s really when it comes, you know, where we have to say what tools we have to be able to address that problem.

Frank Criscione: So we know we’re just going to keep generating more and more data. And I’m listing a culprit of that as one of the examples. And we know we’re going to have to analyze all of that data. So let’s ask about you know all right. We know more data is going to come. What’s going to generate it? We know that we’re doing all the clinical diagnostics. All of the core laboratories are generating a ton of data. Another trend right now is these wearable devices. So I think this trend started with Fitbit everyone measuring their heart rate, their simple biometrics. But now with Dexcom, I think that was released or FDA-approved back in May. Now we’re measuring glucose, and that’s an over-the-counter device that you basically can measure your glucose level at 24 over seven. That type of Monitoring is only going to expand the amount of data that is generated. Now these are good things to have because of course, you’re gathering more personalized biometric data. But then you wonder what are you going to do with that. Who’s going to process that? Well, fortunately, we have good stewards of data, i.e. AI. And so with AI, what you wind up seeing is not only are the algorithms that are currently being trained on really, really robust and I guess curated very well these data sets, they’re also widely being socially accepted.

And so if you combine these two sort of, I guess, technologies and tools where you wind up having is this idea where you can just monitor a person with or monitor the biometrics on a 24 over seven basis. Generate a ton of data, and then also utilize the tools that I provide to analyze the data, find trends, and better provide patient care. So let’s go to the next slide and we’ll talk a little bit about some of the examples and some of the, you know, the current states and what that market looks like and where we think that market is going to head. So first let’s just talk about or talk about wearable diagnostics. These are just a couple of the metrics that are measured currently that are capable of being measured with some of the devices that are available on the market.

Frank Criscione: And if you look at these, you can see that these are pretty much if you go to the doctor, these are what they’re going to measure. The second you sit down and they try and do your intake, and to be able to have that ability to monitor your resting state, day to day, when you go to the doctor initially, you can wind up seeing, hey, this is a better way to get a baseline for this particular patient. A better way for us to determine. And if there if there are any aberrants or aberrations in that patient’s profile.

And so we have the technologythatt is currently being used. And now we’re just waiting to see who’s going to marry the two together and put all this biometric data into patient care specifically. So a little bit about the market. , the wearable market is growing pretty rapidly. North America is the largest market currently, and APAC is growing the fastest. And so some of the market leaders I already mentioned, Google, Garmin also a market leader when it comes to wearable devices. And Dexcom, which again, most recently the FDA approval for over-the-counter glucose monitoring. , and so where are these wearables going to take us? And so again, novel measurements, I say this, as you know, this list that I put over here in terms of the biometrics that are provided, is the beginning.

Frank Criscione: Of course, there are going to be other metrics that we can measure. , there was one that I read in an article saying that they want to measure blood alcohol content for people that are currently being monitored. So they have a wearable, they measure their back and make sure they’re behaving. , and so things like that let us know that there are a few limitations when it comes to the metrics that are being measured, but what they need to be is actionable. So what are doctors going to need to support the diagnoses that they’re going to be providing? And so this leads me to another aspect of wearables. , as we know from Covid, telehealth wound up having an insane boom when it came to the pandemic. And so because of telehealth, you sort of miss out on that, that initial doctor’s intake, figuring out what that baseline is with wearables, you’ll be able to just upload that information directly to the doctor to start your visit. So all of a sudden, you’re now improving this sort of remote care aspect. And then finally, primary and supplemental personalized medicine again, if we can gather more data and process all that data for individuals, that only enables us to better provide a diagnosis or a diagnosis to what their ailments are and understand how our treatments are currently being effective or not effective for a given person.

Frank Criscione: So wearables I see as being only the beginning when it comes to how we are going to be implementing, I guess the next wave of diagnostics and patient treatment. But again, we mentioned earlier that the whole idea of wearables is almost the culprit in producing more data. And so I’m a data junkie again. , I,, my background is very much in bioinformatics and biochemistry. So of course I’m always going to say more data is better, but we need to be able to process that.

So when I talk about AI advocacy, everyone always talks about, you know, AI algorithms and AI tools and using AI for diagnostics. I think that it’s AI is going to be most beneficial when it is an advocate for a patient’s health. And what I mean by that is in curation of data, in being able to produce data sets and pull out information that is beneficial and readily accessible to those providers. And so again, we’re generating huge amounts of data. These doctors, again, there are only so many hours a day that they can devote to a particular patient. With the assistance of AI, they absolutely will be able to gather that data at a more at a faster rate and be able to provide better diagnostics.

Frank Criscione: So who is currently doing that? There’s currently this advent of what they’re calling smart hospitals. I think it’s a cool name, but they’re taking all of the data from their patients and creating this sort of AI curator for their EHR. And this is a fantastic thing that is being developed because you wind up creating intake forms, you wind up creating testing forms. You wind up creating everything in a digital form for this patient that allows patients to go through the system without losing anything. And so the reason why I say, you know, you might lose something. I always get this when you go to the doctor, you go to the hospital. Someone says, when was the last time you got an operation? Give me your operation history. Well, I won’t have to remember that at all, because in AI, an advocate would be able to present that data on my behalf. And that is one of those areas where I might say, oh, I remember when I was maybe 16, I had this operation, but I don’t know if I’m going to remember that when I’m 80. And so if I’m, you know, as we have an aging population. Ai advocates come in and support the patient when it comes to data access.

Frank Criscione: Now I know I skipped ahead in terms of that patient advocacy. I also see, you know, I being implemented as a coalition of hospital and lab consolidation, and we know IDns are not going away. I think they’re only going to grow in and ber. And being able to track patient data through an IDN is going to be, you know, better facilitated with the implementation of AI. Finally, as I mentioned, I did a little plug with a lab in a box about how I think clinical trials are going to benefit from the lab in the box. I think AI is going to improve, clinical trials as well. Now, a couple of clinical trials, AI, and wearables.

And all of a sudden you revolutionized drug discovery, being able to monitor on a day-by-day, hour-by-hour basis how drugs are affecting a particular individual is going to change how we progress through a clinical trial, the data that is going to be required, the data that is going to be acknowledged is going to help people out. Because again, when we find or we always say when it comes to drug discovery, we want to fail as early as possible. This not only enables us to fail early but to understand why we are failing early at a much higher degree.

Bruce Carlson: So of particular interest to this audience is, of course, drug, you know, drug discovery and drug clinical trials. But increasingly, if you look at the IVR or even some of the American, if this LTV, regulatory structure is going to proceed and survive legal challenges and the like, there’s going to be a lot required of IVD developers as well. So that sounds like something that might contribute and might it could be right in the nick of time for, for, labs and I should say labs who have lab-developed tests, and IVD developers who are looking at those regulations saying, I got to provide so much clinical data and this is difficult. And maybe now the AI helps with that.

Frank Criscione: And I think that that’s a great point. In the chat, one of the questions came up about how, you know, these data insights might be managed or regulated or managed, approved and regulated by the FDA. And so one of the things that I think, you know, do we think that AI is going to supplant doctors for decision-making purposes? I don’t think that’s going to happen in the immediate. But what the FDA can, you know, say is that having this sort of curation of data, which we already have with EHR management systems, is, is going to create an environment that is regulated and safe. And so, yes, the algorithms that AI is currently being any sort of analysis that, that is done for, any, any IvD, that those algorithms are FDA processed. And so this type of basically implementing, implementing AI in that fashion. Of course, we’ll go through that same sort of process. But what we’re arguing is that the organization that AI brings is going to benefit the providers much more than any sort of analytical capability, at least right now, because we have this data burden that we need to solve.

Bruce Carlson: Great insights. And it’s something that really fits, , exactly what we’re, we’re looking for. In this particular webinar, just because everyone’s talking about, more or less AI and two ways. One is, yes, the AI doctor we keep hearing about, it’s coming, it’s going, it’s going. You know, it’s going to be just as big as imaging. Well, you know, maybe in some areas. Certainly imaging related. I’ve certainly and already there and also in the workflow in the actual lab management workflow and, and this is an area of potential AI use that probably isn’t being discussed, enough. let’s see and thanks Aaron for that question. And it looks like we might have, let me see if there’s any more quick check there. No, we’ll, we’ll, we’ll jump to .

Frank Criscione: you know, I think you raised the important point of, you know, will I, you know, wind up replacing our doctors. And. I don’t think so. I think that we need to not worry about that necessarily right now. I think that we need to figure out exactly how we can utilize AI as a tool for bettering diagnostic capabilities. And so that’s where I think, you know, everyone’s mind is heading. Everyone’s bolting AI, I onto their platforms, and so I’d be interested to see, you know, how maybe in the next, you know, 1 to 2 years as this AI keeps or AI implementation keeps increasing, I’m interested to see how doctors begin to utilize that, that sort of summarization capability. Pull out these records for me, make this trend line for me and see how that’s going to affect patient health.

THE KNOWLEDGE GAP IN DIRECT TO CONSUMER TESTING

Bruce Carlson: Great. Thank you very much, Frank. We will jump to David Freestone the founding partner at Bridge Works. And he’s going to talk about at-home testing and the knowledge gap that exists right now, which might be an opportunity and a challenge. And so, David, your slide.

David Freestone: Well thanks, Bruce. I appreciate the opportunity. And Rob and Frank, great information that you both presented. So hopefully I can live up to the standard and the bar that’s been set. But yeah, as we start looking at, at-home testing, you know it does kind of tie both of the previously presented topics all together. You know, there’s a sample collection component of it. And, and how do we go about that? And then there is all of this data and information that’s generated. , you know, we always use a saying he who controls the data wins. You know, it’s not really about market share getting instruments or that in there. It is who can control that data and who can do the most with it. And that’s really where kind of the at-home testing that over-the-counter testing, you know, really comes into play. And there is a lot of knowledge gap, that that exists there. If you kind of look at that, that diagram there on the right-hand side of the slide, it’s kind of like if you’ve thrown a stone into a pond, right? And those waves radiate out from there, that ripple effect that’s created and that’s really that extending of that care continue from whether it’s being in a physician’s office or, or the hospital, out to the bedside and then out, you know, to more of the urgent care setting and the community-based setting and then out into the home.

David Freestone: And what that does is, it improves accessibility and it helps serve more of those underserved markets. But it brings a whole plethora of issues and considerations that need to, you know, that need to be considered. , primarily it starts with technology. , you know, we’ve surpassed, honestly, a lot of the expectations. So I’ll probably share a little too much. I’ve been in diagnostics for about 33 years now. I started as a med tech and started working in the lab. So when Frank talks about, you know, loving data and that I just love the laboratory, I mean, that that’s literally in my DNA. I’m sure after all these years of spending years in the lab. , but, you know, to think that we could be doing molecular PCR tests, full PCR testing in a home, you know, these days, I don’t think any of us considered to what level we would be able to do that even. Even just as short as 5 to 10 years ago. And again, just because we have the technology, should we do the technology? And in some of these areas, is it really, truly needed? Is there a commercial, a technical, a patient benefit need, you know, that’s there? , what we saw during particularly during Covid, as, as both Frank and Rob have mentioned is we saw a lot of advancements.

David Freestone: , you know, things that we didn’t think would be here probably until 2028, 2020, 2030 that are that are really here now. And we saw a lot of leapfrogging even from a regulatory perspective. You know, the traditional advances is you come out with a high or a moderately complex test, then, you know, you do some tweaks and some modifications and you get clear waved. And then, you know, the eventual down the road plan would be to get an over-the-counter claim so that you could go into the home. Well, what we saw during Covid is most a lot of diagnostics were were actually forgetting about the whole, you know, nobody wanted to go highly complex. Very few even went moderate. Everybody was really focused in that, that wave or that that OTC claim. And what that really did is that really started to change, you know, all the way back from a clinical trial perspective, all the way through a commercialization and a product development perspective, what was being considered as far as the value proposition, you know, of a test or of a platform, and one of the parts that that kind of got lost in that was really that cost versus benefit. You know, the price per test of these at home or over-the-counter tests is much higher generally than an automated, you know, central laboratory, , type product, whether it be lab in a box or, you know, the largest chemistry or immunoassay systems that are out there and how how is that affected from the patient? Is there that return on investment of of having that testing platform in the house versus into this more centralized, , , ability? And as you know, in home, we’re usually talking there’s, there’s two different realms.

David Freestone: There’s in-home collection where you grab the get your saman plus, drop it in a box, go in the mail to a quest, a LabCorp, a Hims and hers, and Everlywell those, those types of companies. Or you’re opening the box, taking out a diagnostic device and running the test on yourselves like a, you know, the now DH or new syphilis test or Lucira three EO all of the the the immunoassay and antigen type tests that are out there Binax and Cardiacs those types of things. So you’ve got this broad spectrum of things that can be done in the home. But there’s there’s a cost that’s there because as we drop down to reimbursement, which is kind of the next thing, who pays for all of this? It’s not like Covid where the government or your insurance carrier, you know, will allow you to call in order and you magically get these, these things free in the mail. , you know, we’ve kind of gone back to where you as a, as cons er are expected to pay for this.

David Freestone: And, you know, as we move forward this technology, again, has a cost associated with it. How do you keep that genie in the bottle from a reimbursement perspective? How do you control those costs? Are you going to allow your covered patients to be able to just order willy-nilly? Hey, I want ten of these and five of these sitting on the shelf in my bathroom. So when I do get sick, I’ve got them. , and really, how how do we how do we limit or cap or define the value of those, those at-home tests? , when a hypochondriac patient, you know, orders one with every sniffle or twinge that you know that they might get. , as we look at the market, you know, that expands that patient base. , and it’s seen as a high growth or expansion market for the, the open market, but primarily these providers, the Sutter’s, the Kaiser’s, the Intermountain Healthcare’s the Sanford’s, you know, they have the most to gain from doing this because they have that control of a patient. The entire perspective of that care continuum for, for their covered patients. , and so it does become much more of a, a way for them to build really what that value proposition is and see those benefits because they are so fully integrated into those patient lives. As we open out more into the open market, that becomes much more, you know, much more difficult of a, of a consideration, to have.

David Freestone: And then what kind of proof sources and that that are out there when, when we were all up to our eyeballs in Covid testing, which, you know, made great advances here. It was perceived that there was a lot of this value. And we thought we observed a lot of the value, but we didn’t have a precedence to set it against. You know, this was our first time in a global pandemic. , you know, to deal with a lot of this, everybody was just doing the best job they could. , because they were running around with their hair on fire. That’s what happened to me. , and the test was only one part of the puzzle, and that continues to be the issue. It’s really what is that impact, you know, in that value is so dependent on several other variables. The integration of the data, as Frank was talking about, the utilization of the test, and confidence in the results. Rob covered that a little bit in his and the ability to treat upon that result. And then can patients have a test on hand? You know, if I can run down the road to the clinic and for a $10 co-pay in about 30, 40 minutes of my time, get the test run that I need, get the result.

David Freestone: And a couple hours later, I’ve got a prescription versus waiting on the Amazon driver to deliver my test the next day, run it, and then go through all that rigmarole, you know, is there really a balance or a savings or a benefit there for the patient and the health care? That kind of takes us to some of the drivers, you know, in this area that greater access to care. And Frank, you touched on it as far as, , clinical trials, that’s really a, you know, a valuable benefit of of being able to test and monitor and, and capture the data from these patients in their home is now when you’re setting up a clinical trial, you’re not just looking at a ten mile radius around major medical centers. You can really drive, you know, out there into what, much more rural settings, , much broader, patient pools of both, you know, age and sex and race and all these other variables that really drive a good clinical trial. So you start to get that greater access to patients and give patients that greater access to care. And again, that’s really what’s driving some of that high growth, , you know, for this market that we’re seeing, because it really does expand that scope. And that data generation, which we’re all learning is, is becoming, you know, so very important, expanding.

Bruce Carlson: So with Covid, of course, the big driver was, you know, to some extent fear the. I need to get back to work. , I need to we need to know if we have to isolate all of these things. Which encouraged. There was there was almost no limit to if we can do home testing, how fast can we get it out? When you shift to other diseases, , there could be. And maybe I’m. I’m wrong here that there’s not as much, but there could be resistance in that. , it always seems that governments and payers in the back of their mind, maybe not something they state in policy is a fear of, as you say, the hypochondriac, a fear of greater cost down the line.

David Freestone: that’s a great point. And that’s really what I’ve got. There is a point as far as that more sophisticated cons er right that that that evolved during the pandemic. , a lot of that, that FUD factor, the fear, uncertainty, and doubt both on the patient side as well as on the caregiver and the payer side has been diminished. , you know, again, that that perceived value and actual value. You know, we do have a lot of, of real-life examples of, you know, of how that has improved, both from an acceleration of, of regulatory approval of payers being, you know, much more of an active participant in that and the example of being able to proactively order flu and Covid tests, you know, from your payers. , and then what, what that, you know, has done as far as the, the complexity of the patient that we’re now treating. , you know, patients aren’t blind, aren’t nearly as blindly going in and just accepting, you know, the level of care that’s given. They’re asking way more questions. You know, we’ve got WebMD or as I like to call it, W-w-w cancer.com, because that kind of seems what all the results lead to is, oh, you’ve got some type of cancer. , but, you know, people are taking much more control of their care.

David Freestone: And now we’re finally starting to see that that next level of acceptance that’s being driven by that from the payer perspective, from a regulatory perspective, and from these, you know, these idns that the telehealth components and, and that you have a high percentage. There were a couple of studies done right there at the end of Covid where you had, depending on the study, anywhere from 18 to 30% of patients that would prefer a telehealth visit over a brick and mortar visit for the rest of their lives. I mean, some of them have no intention of going back to a doctor in person. If they don’t, you know, if they don’t have to. And so to your point, kind of that fear and that, that, that over or under utilization that’s there, I think we’re starting to find some, some homeostasis. You know, when it comes to that. And and again, I do think, as Frank mentioned, a large portion of that is it’s all driven by data. You know, if the data will back it up, if there’s value there for for the payers, if there’s benefit there for the physicians, and if there’s higher satisfaction for the patients, it’s going to drive and continue to drive this. That’s that’s just the nature of the beast.

Bruce Carlson: Do you see particular disease areas like Q had a Q had a I thought that it was fascinating. And I don’t want to put you on the spot if it’s like we don’t you don’t have to talk about it. But if you since you work with them. But but I just note, I just note for myself that I really found Q’s model of the subscription model interesting and maybe something someone will pick up in the future. But it is. Is that kind of the future? Is there a particular disease areas, where where you, you see working? We we talked about a lot of people are talking about STIs, which would you think that’s, that’s one of the, the top areas that that we’re, this might at home testing might work.

David Freestone: Absolutely. STIs was was always identified as one of the key primary areas because unlike infectious disease, you know, Covid, flu, strep throat, some of those types of things you’ve got that added benefit that at home testing does. And that’s anonymity, right. You don’t need to worry about had a wild weekend in Vegas. And now I’ve got to go to my GP and I’ll run into three of my neighbors and two ladies from the carpool. you know, they’re in the waiting room. That and then I’ve got to explain that to, to my spouse. So that’s that’s another factor, you know, that that needs to be looked at outside of just those basic patient satisfaction and ability to expand care is are there those more intrinsic things that are that are there or esoteric things that are there like anonymity with sexual health testing? And that really seems to be one of the real drivers, you know, for that. , so I do think that there are some of those areas. , as, as we move forward, you know, we’re starting to see pulmonary function testing, moving in into the home and more of that remote patient monitoring, as mentioned earlier, with diabetes and some of those types of things, you’ve got some oncology tests that are now, you know, looking they’re looking at having the ability to monitor these patients much more real time, involving a diagnostic test in the home, and then being able to alert the physician prior to any type of exacerbation or, or, or issues coming up with the patient. So you can really start moving into the more of that proactive testing. I think those are some of the areas that are really going to drive. The menu and the types of tests that we’re going to see much more beyond just that convenience factor or oh, this patient might be might be infectious. We don’t want them coming in and coughing all over everybody in the waiting room, which is kind of been the, you know, the primary drivers over the past few years with the pandemic.

Bruce Carlson: Well, just a note for everyone listening. You know, we do have a chat and we do have questions. So if you want to ask a question of us, that’s that’s a great, , a great thing. , I, I really do think that integration step is, is interesting where a lot of times we’re thinking of and in fact, Rob’s going to talk about in a second about the patient themselves being the one driving all this at home testing. But I think also in a lot of cases, it’s going to be doctors saying, you know, does Sam, I need you to I need you. You should get an at home test and then get back to me, things like that as it gets to be, , more common. You know, they’ll be driving a lot of this activity as well. I think we just had a question. So I’m going to see if I can.

David Freestone:And I think that that’s that last box really that that integration. Right. Are the physicians going to treat off of those results. You know we’ve got the OG at home test pregnancy test. Right. Doctors don’t question anymore if if a woman has taken an at home pregnancy test, comes in and says, hey, you know, I’m positive, , unlike a lot of the other tests where they will go ahead and retest and, and that, you know, they trust the at home, glucose readers. And now with technology like Dexcom. So there are already precedents set there. But it’s really how trusted is that result. Can they treat and diagnose on it. And then, you know, move forward in more of a, an ongoing monitoring state without destroying things like antibiotic stewardship and, and that, that that patient reliance and trust factor, you know, that exist with, with a, with with a care provider. So you know that real integration of of the at home into that overall both the electronic medical record and then that overall care continu of the patient, that’s that’s what’s critical. And then those are all kind of of supported or driven by the reimbursement, the convenience, the the ability of the patient to test and, and, and the technology itself. So it really does kind of become this, this, you know, eight legged monster very, very quickly. , you know, and all those things need to be considered. It’s it’s not just the technology. The technology, honestly, is the easy part. It’s what we can do with the technology and how we get it supported.

Bruce Carlson: Well, great. I’m going to j p right to . And thanks, Dave. That was great. And I’m going to j p right to Robert. And Robert is going to talk also about DTC testing from a little bit different side for more of that patient investment side. It’s something that, Rob and I have talked about and that he’s talked about on LinkedIn a bit. There is for you, Rob, a question. And we thank Aaron for his question there. , and you can decide if you see that, Rob, whether you want to integrate that into your answer, into your slide, or whether you want to address it now. And if you want me to read it for you, I’ll do that as well.

Rob Lacroix: Yeah. Go ahead.

Bruce Carlson: Go ahead. Okay. So the question is, for Rob, you talked about physician reimbursement during a patient visit. How does the industry continue to make sure CMS and the payers understand the value of all the new technology and data?

Rob Lacroix: That is a very good question. And part of that. , the the result that the doc from from the data that the doctors can leverage is valuable. It’s going to be cash. It’s not going to be a payer to begin with. It’s going to be cash. But what happens is. And, once you look at a patient from a doctor’s perspective, think about it. It’s not just the patient. Doctors see multiple patients, and they kind of see. Patients may have a lot of commonalities. So demographically you now can start to. To link things together. And that’s the power of AI. And then once you’ve done it at a doctor’s office you can do it in, in a, in a, in a geographic area for, for demographic subsets. So that all becomes available. And then now you’ve got it becomes post hoc. And from a regulatory standpoint, when you think about it in our industry, you know, we do five 10-K submissions. You got 240 samples, 120 men, 120 women. They’re all healthy. Or here’s our test. It does what it says it does. Think about it. There are no studies afterward. The lab companies don’t do it. You know, they have to do it for a part of it. But the OEMs don’t do it. So now you’re utilizing the data post hoc in coordination with those test results. And I think that has immense value. And it doesn’t. And it’s not just it’s for the for the doctor and the patient, but also for the OEM. They can take that and then present it to a pharma company or a regulator. It opens it all up so that at that point you’re going to see, payment for it.

Bruce Carlson: Great. Thanks, Rob. And we’ll jump to. oh. Did someone else want to j p in? Go ahead. oh no. Okay. I hear thing you hear things in these webinars. so I’ll j p to your next slide there, Robert. You can take it from there.

Rob Lacroix: Okay. , you know, I’m not going to actually, David hit OTC, so I’m not going to cover that too much. I think that it’s just there. I just have it categorized here. And also David mentioned the type of testing you would do some of it, you do the testing and you get the result at home. For some of it, you have to provide the sample and then you have to send it out and you get a result. But let’s look at it from the patient. What is available to the patient today and what does direct-to-consent testing give the patient? Access it’s convenient knowledge but most importantly it gives control control of their coverage. So who owns these results? Does the insurer own the results? Not if the. Not if it’s self-pay. Insurance doesn’t own it. The doctor doesn’t own it. The patient owns it. And that means they control who has access to it. So that’s very important. That’s completely different when your doctor does a send-out test now and you’re covered by insurance, your insurance company owns those results. You get to see them but they own them. And that completely changes with direct to cons er. When you think about it you’re paying for it yourself and a lot of tests insurance companies won’t cover, especially when you get into situations where anything DNA-based outside of Covid, they’re not covering it.

Rob Lacroix: It’s very difficult. So you’re going to pay yourself. So let’s think about it. You’ve done it. You’ve sent you’ve done the test. You paid for it. You’ve got the result. It’s FDA or it’s a clear lab. Can you present those results to the doctor? The doctor says, okay, we need we need to look forward. Can those results be invalidated by the insurer? They can’t they can’t touch it. It’s it’s an actual result. So that’s a very important thing because when the doctor uses that result, which is its objective data to order follow on health care, it limits the insurer’s ability to deny that follow on health care. So it’s that’s completely different than the way health care works for people with insurance. Basically I’m going to I’m going to order some tests. Insurance coverage. Insurance companies going to cover it or they’re not. And if they don’t cover it, it falls back on the patient. But by the patient doing it up front, it eliminates the insurer from ever saying that you can’t take can’t get care. So that’s very important. And it’s it’s a part of the testing for, you know, people doing it at home that, I think is going to grow as people understand what’s available out there for them. Okay. So what does this mean for the lab? Because, you know, the labs have, for the labs.

Rob Lacroix: This is great business. They set the price. The patient agrees to pay the price upfront. It’s. They supply the credit card. There’s no haggle. , as soon as the results are reported, they get to Bill. It’s just great high-margin business for them. And you get repeat customers. Today is day three of Cyber Monday where Quest is offering up to 35% off testing. I don’t think they’re giving a Cyber Monday deal to the health insurance companies, but to me, I’m special. So this so there’s a definite, you know, a definite opportunity for it to continue. And not just the OTC testing, but the testing that’s done at Quest and LabCorp and the more esoteric testing. So this is testing where it’s probably DNA-based. It’s your DNA or what’s inside your DNA. And it’s it’s clear it’s an Lt, but it wouldn’t be covered by an insurance company. Historically, you’re going to have to self-pay. But if something is something comes out of that lab report, you now have the power to go forward with that, with that information to your doctor, and, then get follow-up care. And from a testing standpoint, there are over a thousand tests available today to people. It’s out there pretty much everything available at Quest or LabCorp. You can get it.

Bruce Carlson: Great. And I think yeah, it’s it’s it’s an interesting trend that we’ll keep watching when it first started. And unfortunately, it was the concept was so tainted by one bad actor. I almost don’t want to keep using the name Theranos all the time, but one bad actor that then it maybe put the industry on the back foot a bit. But these were already plans that were in place and a lot of like Quest and LabCorp doing. And it’s not doesn’t seem to be going away. The idea of going in and getting a test. I mean, there were some early pioneers of doing like any, any lab test now in places like that. But now you’re getting away. The two majors have programs, and as soon as the cons er wake more, which to me is just a direct to cons er advertising campaign away, this could get big.

Rob Lacroix: Yeah. Think about it from a doctor’s perspective. If a patient comes in with their CMP, CBC, lipid panel, and a urinalysis to the visit, and hands the test report to the nurse, the doctor can look at it before they even see you.

Bruce Carlson: Now, would the doctor some of them are going to want to get paid for.

Bruce Carlson: Yeah. I was just thinking that, . Yeah, some of them are going to want to run it.

Rob Lacroix: Well, I mean, if it’s coming from Quest or LabCorp, I don’t think they’re going to question that the result is invalid, you know. So, you know, I mean, that’s really what it what it comes down to. And you’re talking 100, 125 bucks and you’re getting the routine test panel, which is what what’s your co-pay on lab tests? You’re almost to the point where it’s it’s it’s almost at equilibrium in a lot of cases even without the 35% off.

Frank Criscione: Especially early in the year when you don’t have your deductible met.

Rob Lacroix: Yep. Yep. So so so that’s the thing. So I think there’s there’s definitely, this is this is going to grow for Medicare I don’t think because that’s it’s all Medicare just covers testing for older adults. But people with insurance I think that’s the that’s the market. That’s the segment for this for this market. Yeah. Great.

CONCLUSION

Bruce Carlson: Well Rob, much appreciated. Rob, David, and Frank. So we’re going to end the webinar. , and I want to thank everyone for joining. We know there are a lot of webinars out there trying to make these worth your time and IVD-focused. So I hope we accomplished that.

And please, by all means, you know, sign up and give us feedback. And if you know you, you have an idea. If you’re a company that maybe wants to sponsor a webinar, maybe you have an idea. Maybe you have a partnership idea, you want to talk to us. We’re very open people. We’re very friendly and involved, and we’re looking to do different things and just make help, make IVD a little better while we also have our, businesses as well. , thanks so much for your time and thanks for attending. This will conclude the webinar.