Lyme Disease: Is a Better Diagnostic Test Around the Corner?

Welcome to Clinical Lab Chat, part of the MEDQOR Podcast Network. I’m Chris Wolski, Director of Business Intelligence for CLP, and today I’ll be speaking with Dr. Artem Rogovskky and Dr. Dmitry Kurouski about the work they’re doing to develop a more sensitive test for Lyme disease. Now, Artem is a member of the Department of Veterinary Bio Pathology in the College of Veterinary Medicine and Biomedical Sciences at Texas A&M and Dmitry is a member of the Department of Biochemistry and Biophysics, also at Texas A&M so we have the Aggies well represented today.

Welcome Artem and Dmitry to Clinical Lab Chat. Well, we’re very excited to talk to you about your work. I do want to make it very clear that you are still in the research stages and this is not, unfortunately, an available test, not yet. So let’s talk a little bit about Lyme disease and about your work. So Lyme disease, I think most of our listeners are laboratorians, but for those who aren’t, or those who don’t work with Lyme disease very much, Lyme disease is really becoming a scourge for a lot of people in the US mainly because it’s very, very tough to test for. So what are some of the limitations of the current… I know there’s some limitations for the current testing. There are tests, but there are a lot of limitations so Artem or Dmitry, if one of you would like to just kind of outline what some of those difficulties are.

Since I’m a Lyme disease expert on this project, so I’m going to start off with this. So there’s a test available out there. It’s FDA approved in the United States, so [inaudible 00:01:46] called two-tier serology testing and it’s made up of two actual tests. One is a ELISA test, which is a serological test and it’s very sensitive test, so it can give you a lot of false positive ones. And once the ELISA is positive, then it is followed by a more specific test, which is a [inaudible 00:02:11] blotting or immunoassay test and that test is a highly specific, so two-tiered system has been a while on the market and unfortunately it has a lot of drawbacks. One of them is poorer sensitivity, especially during early stages of Lyme disease.

So as an example, you can have a clinical symptoms path [inaudible 00:02:41] specific to Lyme disease, but as erythema migrans than skin lesion but at the same time, the sensitivity of that test during early stages can be up to 40% only. So it’s as low sensitivity and as the disease progresses, then that sensitivity becomes higher and higher but it is very important to start treating Lyme disease at the early stage when [inaudible 00:03:11] are still not well hidden in the system-

Right.

[inaudible 00:03:15] in the human body so that’s the challenge.

Right.

The diagnostic, a lot of people, a lot of labs are working towards creating better tests. Ideally we want to have a direct test or indirect.

Right, so that’s kind of comes to your goes research, which is really interesting. I read, you sent me some studies, I read over those and you’re both are very different disciplines, so your research is very multidisciplinary. So it uses raman spectroscopy and can each of you discuss your role in this research? Maybe go over a little bit why raman spectroscopy was the method that you kind of settled on or the method that you’re exploring.

Yeah, let me take this question.

Okay.

So it’s completely correct. Like you said, we have not only multidisciplinary team, but we have a team of researchers that have completely different but complimentary expertise to solve this problem. Artem is an expert in Lyme disease, whereas my area of research is development of innovative spectroscopic approaches that can be used to probe the chemical structure and composition of samples. And raman spectroscopy is one of these technique that is fully non-invasive and non-destructive and what we demonstrated is that using raman spectroscopy, we can detect and identify different strains of Borrelia burgdorferi, the pathogen that is causing Lyme disease by the very quick and non-invasive analysis of blood, both in mice and in humans. And we expect that this method, because there are also handheld instruments, can be essentially performed directly in hospitals or analytical laboratories for the confirmatory diagnostics of Lyme disease.

Now if I understood the studies that Artem sent over to me, I say this, I think almost every show, I am not a medical person, I’m a writer. I’ve been covering health for a long time so please sort me out here, but if I understand it correctly though, the test results are not direct, it’s more… I find it really interesting. If you could kind of describe how the results or how you identify or how the results work maybe in a little bit more detail because it’s not like a direct sort of result, it’s more indirect if you what I mean?

Maybe I can get started Artem.

Okay, okay.

So it is completely correct. What was done by another group of researchers that utilize mass spectroscopy is that they found that in the case of Lyme disease, the chemical composition of blood is changing and this changes acquired drastically. The changes are owned to about 30 different compounds that change in the concentration if someone gets Lyme disease and raman spectroscopy is the technique that can probe the composition of the sample so what we probe is the change in the profile, the chemical profile of the blood and through these changes we can identify the disease or we can diagnose a disease.

Oh.

Of course there is a lot of [inaudible 00:06:45], just one second, but what is exciting at this point is the specificity because we, together with our team, worked on six different varieties of Borrelia burgdorferi and we can differentiate between these varieties using raman spectroscopy. But of course there is more to do to complete this work.

Right, right. Okay. So that was going to be my next question. So this isn’t just for Lyme disease, it has some potential for other types of related tick-borne diseases.

I want to add to this discussion.

Sure.

That question, your question is [inaudible 00:07:22] it’s actually so far raman spectroscopy shows promise as being indirect test-

Right.

… and I’m a bad guy on the team. I’m always trying to be skeptical and I think that’s a good thing as well.

Yeah.

And that’s why, as you mentioned at the very beginning of our interview conversation is that it is too early to be so super excited about this test. We still-

Right.

… have a long road ahead of us and we still have to develop those multiple algorithm that would allow us to be very specific and sensitive towards identifying Lyme disease patients. So we’re still doing the work, we’re still continuing [inaudible 00:08:11] and I have to acknowledge the Bay Area Lyme Foundation here, without their support, we wouldn’t have been able to start this project but we got the Emerging Leader Awards in 2002 and that allowed us to start working towards this project.

And also we’ve got funded last year to continue to working on this project. So there’s a lot of things to do. As an example, for now, we are testing about 400 samples, human samples in a blind manner so we got those samples, again, some to acknowledge the Lyme Disease Biobank, that’s a repository of clinical samples so we got 100, I think 10 samples from them and they’re all coded so Dmitry and I do not know their status. So we don’t know which ones represent LD confirmed cases or Lyme disease negative cases. So we are doing this in a blind manner to actually be more objective about the algorithm that Dmitry used to identify 90 samples in our published work. So I’m trying to be skeptical here, people get easily excited over our new test, but-

Yeah.

… there’s still a lot of work to do.

Yeah. Well, and we talked about this in our pre-interview that you’ve had patients who have shown up who are ready to give you their samples. Yeah, it also reflects the need for a better test so I think the excitement, I think, is understandable in that regard. So you talked about your, you are doing some testing, or you’ve done, I know from the studies you sent me, there’s been some tests with, I think, animals, mice in particular and now you’re moving on to testing human samples.

What’s the next steps? Why don’t you walk us through what your next steps are? What kind of timeline? I mean certainly there’s a lot of steps, so there’s a lot of variables involved, but what kind of timeline are we talking about with a test like this? ‘Cause I think that’s a very interesting thing too, because we’re always very anxious. I think we got, with COVID, with all the tests that were… It seemed like they were created overnight. I think that people don’t understand, both laboratorians and the regular public don’t understand how long some of these processes take and why they take so long. So maybe you can walk us through a little bit about your next steps beyond the human samples, what’s after that, once you start working out that algorithm.

So the timeline is hard to predict, but we have already [inaudible 00:10:56] this project that was funded again where we are analyzing the samples, human blood samples in a blind manner. I think we are done with over a little bit over 30% of those samples.

Okay.

And we still have to analyze the rest of the samples and submit the results to the Lyme Disease Biobank where they would decode the samples and share their results with us. But then the next step would be to test some blood samples from human patients that are free of Lyme disease but there were diagnosed with other diseases so that’s just to address that specificity concern. And then we, Dmitry and I have an idea now, and I’ll let Dmitry talk about this more, where we actually want to apply raman spectroscopy to develop the direct test and that’s-

Oh.

… something we’re-

Okay.

… trying to initiate at this moment. We still have to get some funding for that but there is a still great possibility of, or actually using raman spectroscopy as a direct test. And I will let Dmitry speak in that.

Well, Dmitry, I’m all ears, let us know what this is.

Right. Well, before I come to this, let me elaborate on what Artem said. This exactly demonstrates easy translatable nature of our approach because diseases that we want to look at to compare our responses, raman responses to Lyme disease are sepsis and syphilis, for example so obviously doing this work, one day we will have a good spectroscopic library to diagnose syphilis. Again, this will be done non-invasively, non-destructibly, it’s a big deal.

Right.

And let me also add more excitement to this research in terms of its translatable nature. My group works on diagnostics of plant diseases for almost five years and we demonstrated, we were quite on that stage maybe four years ago but now we understand that we can detect viral diseases, we can detect bacterial diseases and fungal diseases in plants and we already commercialize this approach in regards to the plant research so [inaudible 00:13:13] exciting news will come soon, but like Artem said, there is a way to enable direct diagnostics.

For this, we want to utilize nano structures that will have very high specificity towards specific molecules to Borrelia burgdorferi and through this specificity, we will be able to detect and identify these molecules that are the markers of diseases and the really exciting news is that specificity and selectivity of this approach is very high and I should say that this nano particle approach is capable of single molecule detection. So we definitely expect to have very great sensitivity, but also this will kind of improve the approach itself because unlike indirect, it will be direct.

Yeah. Oh, that’s very exciting. So I can’t wait to hear more about your next steps there, but unfortunately we’ve come to the end of our time today. Artem, Dmitry, thanks again for taking time to speak to me about your work. Please keep us updated. I think this is something that’s really exciting. I think it’s a really exciting approach, really different and I think it’s also really important work you’re doing. Tick-borne diseases are just so horrible. I’ve had relatives who’ve had Lyme disease and they really had to struggle quite a bit so I know how important it is to have a test. I also want to thank the laboratory audience for listening as always, and look for more episodes of Clinical Lab Chat in the [inaudible 00:14:47] and visit us online at clpmag.com and all the main media platforms next time.