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The COVID-19 pandemic has accelerated the adoption of telehealth, vaccine manufacturing, and point-of-care diagnostics, improving patient access to immediate care. In this episode, we welcome Nigel Lindner, the chief innovation officer at LumiraDx, to discuss the transformative impact of point-of-care diagnostics on our health care system. From reducing health inequalities to improving patient outcomes, Nigel explores the ways in which these technologies are revolutionizing health care delivery. He also highlights the importance of scaling up these innovations to reach vulnerable populations and creating a more equitable health care system. Join us as we dive into the future of point-of-care diagnostics and the role it plays in shaping a healthier and more inclusive future.
Nigel Lindner is the chief innovation officer, LumiraDx.
He shares his story and discusses his KevinMD article, “Immediate, accurate diagnosis is crucial to the future of equitable patient care.”
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Transcript
Kevin Pho: Hi, and welcome to the show. Subscribe at KevinMD.com/podcast. Get CME by clicking the CME link in the show notes. Today on the show, we have Nigel Lindner. He is chief innovation officer at LumiraDx. His KevinMD article is titled “Immediate, accurate diagnosis is crucial to the future of equitable patient care.” Nigel, welcome to the show.
Nigel Lindner: Thank you, Kevin. Great to be here. Thanks for the invitation.
Kevin Pho: So we’ll get into the article a little bit, but first off, just briefly share your story and journey to where you are today.
Nigel Lindner: Well, I’ve always had a passion for biology. I grew up on a farm and love nature, so I guess it’s no surprise that I went into the biological sciences. I joined Unilever as a young scientist, where I worked on development and innovation in consumer goods, and then in 2007, I joined the diagnostics industry. In 2009, I became CEO of an OTC diagnostics company in the women’s pregnancy health space, and then in 2011, I became head of R&D for Alere, which is a point-of-care diagnostics company. In 2014, I joined a new startup called LumiraDx, which was really to develop a diagnostic platform that was able to do many different diagnostic tests at the point of care.
Kevin Pho: So you’re on the cutting edge of point-of-care technology. What would you say are some of your biggest challenges in getting physicians like myself to adopt some of the new technologies that you bring to market?
Nigel Lindner: I think the biggest barrier has been accuracy. We really need to provide tests that are as accurate as lab systems, and we can do that now. And then you come into things like cost, even ease of use. I think for a clinician as well, to have a platform that you can do multiple tests on, instead of having different instruments for each different diagnostic test that you need to do, is a major benefit, because you only need to learn one workflow. It’s one instrument that’s sitting there in a lab that’s tight for space. And also, the platform can be used by relatively inexperienced people, so you don’t need a health expert to operate the system. They just need to interpret and use the result for treatment.
Kevin Pho: All right. So we’re going to talk more about how point-of-care testing can certainly move the needle in my world of primary care especially. So your KevinMD article is titled “Immediate, accurate diagnosis is crucial to the future of equitable patient care.” Now, tell us how this article came together.
Nigel Lindner: Well, as I’ve just mentioned, I’ve been involved in the development of a diagnostic platform in recent years, which has taken a lot of innovation. I think for the first time, we actually have the accuracy and the multiple testing on a single platform that clinicians such as yourself are needing. Because of the cost of that system, it can be available in community care settings, so wherever people need to be tested, they can go along. It’s available, it’s affordable, and it gives that result in minutes. So you move toward that equitable health care where, regardless of where you sit in society, you can go and get tested, get a test that’s as meaningful as a lab result, and get actionable results on many different conditions, not necessarily just a single condition, or COVID, or whatever. Eventually, it will be many different conditions.
Kevin Pho: What’s the most common scenario? What kind of tests can you typically do with your system?
Nigel Lindner: Well, obviously, of late it’s been really dedicated to COVID, no surprise there. But COVID’s now in decline. It can do many respiratory diseases or infectious diseases, such as flu and RSV, those sorts of tests, but also more metabolic diseases, such as diabetes, CRP, NT-proBNP for heart failure, those sorts of tests.
Kevin Pho: All right. So walk us through a typical workflow that you would commonly see. Let’s say in the primary care setting, what would be a story or example of how point-of-care testing can really make my life better?
Nigel Lindner: So the patient would come in. You’d have a conversation in front of you, obviously, and they’d tell you what their symptoms are, what the problem is, and you would make a determination: What do I need to test for here? If it’s a blood test, such as CRP or D-dimer or diabetes or something like that, you’d do a simple finger-stick blood test, so just a blood droplet, not a phlebotomy test, not a blood draw, just a single drop of blood. You’d insert the test into the instrument, and then you’d apply the blood, you’d shut the door of the instrument, and within something like 4 to 12 minutes, depending on what the test is, you’d have an answer, a result that’s on the screen in front of you.
It can also be connected, and therefore that result can go wherever you want it to go, to the patient’s health medical record, or it can go to the lab system, wherever you want to send that result. And that’s all over in a matter of minutes, ideally within the patient session that you’ve got going on.
Kevin Pho: So you mentioned one barrier in the past was accuracy, and as you know, in point-of-care testing, there have been several high-profile fraudulent cases where accuracy was in question. So talk about how you overcame some of those challenges. How can we be sure that point-of-care testing results are as accurate as what we get in the lab?
Nigel Lindner: Great question. It’s always been a key issue for us. All of the tests that we develop, we develop against the lab reference systems, running clinicals against those lab reference systems as well. So we ensure during test development, and certainly when the product is launched, that we’ve proven equivalence, not just to ourselves but to the regulators, to the clinicians, to all of the people that need to look at that data and make a determination.
Kevin Pho: Now, you’re based in the United Kingdom, so tell us, in terms of point-of-care testing, how widespread is it among the clinics in the U.K.?
Nigel Lindner: It’s pretty widespread, especially for certain conditions, as I mentioned, for COVID as well, but also increasingly for the conditions that I’ve just been mentioning. I think what’s been missing is that each of those conditions, like diabetes, like heart failure, like infectious diseases, has required a different instrument to do each of those tests. So the paradigm shift here is to be able to do that on a single platform.
Kevin Pho: So different types of blood tests, things like hematology and chemistry, can all be done on a single platform?
Nigel Lindner: Yes, that’s the intent. We have a limited portfolio at the moment. We have about five, six, seven, or eight tests available, but obviously the next phase is to increase that offering, that portfolio, into a wider number of tests.
Kevin Pho: How about in terms of cost? How does the cost of a comprehensive point-of-care system like yours compare with, say, the traditional method, in terms of upfront costs as well as ongoing costs?
Nigel Lindner: Well, cost has always been a key issue that we needed to address when we founded the company. The founders and all of the people who joined have been in the point-of-care diagnostic industry for years and years, so we knew the issues, and we knew that cost was a major one. What we’ve been able to do is develop a novel microfluidic technology system, which we can produce at scale. Basically, it is two layers of plastic with an inner layer where all the technology sits, and we can produce that in high numbers, at scale, very cheaply. And so it’s very attractive in terms of the cost of the strip itself, and the instrument itself is also relatively inexpensive. As for the ongoing costs, there’s very little maintenance to the system, and with any problems, we generally swap the system out rather than send engineers in and have expensive downtime, those sorts of things.
Kevin Pho: Now, in terms of who can run the system, you mentioned that. Can medical assistants do it? Do they need any specific training in order to run the system? Do they have to be certified in laboratory technology? Tell us about the training that’s needed to run it.
Nigel Lindner: If you can operate one of the tests on the system, you can operate them all. The workflow is pretty much identical for every test. The system has been designed for global use, so not just with clinicians in the developed world, but also for use in LMICs. In Africa, we have a program with the Bill & Melinda Gates Foundation for installing the system as part of decentralized primary care in Africa, and for that, pretty much anybody can be taught how to use the system. It’s very simple. As I mentioned earlier, it’s pretty much put the strip into the system, apply the sample, shut the door, and get the result. Those are the four things you need to do. Obviously, the result itself is then taken by the clinician, by the medic, to determine the appropriate treatment.
Kevin Pho: One of the things that you emphasized in your article was that point-of-care testing can help in terms of equitable patient care. Talk more about how it can do that.
Nigel Lindner: Well, one of the areas where we see these systems being used is in community-based systems, so pharmacists, or anywhere in the community where you want to do testing, and you’ve seen within the pandemic already that that’s how it works. If you take the extreme of that system, which, as I said, is in Africa, there’s limited health care, and many people in Africa would have to walk maybe even days to a health care post to get some form of testing. We can install the system. Because the system is portable, we can even have a traveling system, and the system can go to the people. They can get the testing done, not just for themselves but for their family as well, and get the results. The result can be interpreted by a physician. The clinician themselves does not need to be present. They can get the results and then communicate the necessary treatment for that individual.
Kevin Pho: Now, I know in my primary care clinic, I get a lot of marketing material when it comes to these different point-of-care testing systems. If a clinic were to consider a specific system, tell us what kind of questions we should be asking in order to find out whether a particular point-of-care system is the right one for us.
Nigel Lindner: I think we’ve covered much of that, Kevin. I think you really want to know the accuracy. You obviously want to know the cost. I think you want to know the ease of use and the reliability, all of those things. And I think also, increasingly, as we mentioned, the connectivity for the system to get that information where you need it to be in a seamless way is also increasingly important.
Kevin Pho: We’re talking to Nigel Lindner. He is the chief innovation officer at LumiraDx. His KevinMD article is titled “Immediate, accurate diagnosis is crucial to the future of equitable patient care.” Nigel, where do you see the future of point-of-care testing, and what would be your ideal scenario for that future?
Nigel Lindner: I think ideally, and I think what will happen, is it will be available to as many people as possible, via community care settings in the main, at an affordable cost. And the way it will do that is to be able to give the accurate results that we talked about. If it hits on all of those points, the system will be used, and I think it will be embraced by clinicians. I think you’ve seen point-of-care testing come to the fore with COVID. COVID is diminishing now, and as a manufacturer, that allows us to actually now complete the portfolio of tests that we were working on before COVID hit us.
And I think that’s the other thing: You need a large portfolio of tests for the patients, so that they can turn up to the setting and have whatever test they need to determine their health status, perhaps, so that we can ensure health not just by treating a condition but by prevention as well. So we’re also using the system for determining the possibility of them getting disease types.
Kevin Pho: Now, aside from the accuracy issue, which seems to have been solved, what would you say is the biggest barrier that prevents point-of-care testing from reaching the ideal scenario that you just mentioned?
Nigel Lindner: I think scale-up, cost, and availability of the system, and getting enough tests through the regulatory authorities to make them available.
Kevin Pho: And my final question, Nigel: What are some of your take-home messages that you want to leave with the KevinMD audience?
Nigel Lindner: I think point-of-care testing has now been proven. One of the positives of COVID has been to prove how useful point-of-care testing can be. I think we need to take it a step further through increased accuracy of the point-of-care test systems, which is now achievable, and those are the sorts of systems that your clinicians should be looking for. And I think when you’ve got that available in your armory, that you can offer to patients, it’s going to be a key pillar of treating, of fast treatment for the patient while they’re sitting in front of you. It’s not just good for the clinician, but it’s incredibly good for the patient. Obviously, they get that treatment immediately, rather than having to go for further testing.
Especially in an equitable sense, one of the issues that a lot of people suffer with is just the time available to go to get tested, to go and see the physician, to go and get treatment. If you can help them go get tested when it suits them, not take too much time about it, but get a meaningful result, I think that’s the direction that health care will go in and can go in.
Kevin Pho: Nigel, thank you so much for sharing your time and insight, and thanks again for being on the show.
Nigel Lindner: Thank you, Kevin. It’s been a joy. Thank you.
