Radio Cade

Improving COVID-19 Test Accuracy and Early Detection Can Save Lives

March 03, 2021 Vanaja Ragavan Season 3 Episode 27
Radio Cade
Improving COVID-19 Test Accuracy and Early Detection Can Save Lives
Show Notes Transcript

The current COVID-19 tests are not perfectly accurate, which causes several issues with managing the viral spread.  Epidemiological data suggests that 1/4 of all COVID-19 transmission occurs through asymptomatic carriers, up to 14 days before any symptoms are shown. Dr. Vanaja Ragavan, Founder, President, and CEO of Aviana Molecular Technologies, LLC has developed a more accurate test that can lead to earlier detection as well as providing information on the viral load. Wide-scale testing and earlier detection can make a significant difference in achieving positive outcomes and saving lives.

Intro:

Inventors and their inventions. Welcome to Radio Cade the podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. The museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We'll introduce you to inventors and the things that motivate them, we'll learn about their personal stories, how their inventions work and how their ideas get from the laboratory to the marketplace.

James Di Virgilio:

Welcome to another edition of Radio Cade . I'm your host, James Di Virgilio. And today we're going to talk about detecting Corona virus . All of us are familiar with the variety of tests that are being done right now, but none of them are able to detect very important things like viral load, which makes them less accurate than we'd like to see. My guest today is Dr. Vanaja Ragavan. She is the founder, president and CEO of Aviana Molecular technologies, and she's working on something that could be very impactful for the world's fight against coronavirus . Dr. Ragavan welcome to the show.

Vanaja Ragavan:

Thank you, James.

James Di Virgilio:

Now tell us what it is you're working on and how it's going to help us in the fight against curving Corona virus .

Vanaja Ragavan:

Thank you so much for having us on. We are developing a chip based diagnostic system to be able to detect Corona virus so we can detect a lot of different biomarkers and viruses and bacteria. However, at this point, we've pivoted to be able to use our technology to detect COVID-19. And the nature of our technology is based on a radio frequency chip, and it works like a radar system, really in a small little space. One of the advantages of our system is it's called a mass detector it detects the amount of mass that's sitting on top of the chip. And because of that, we have the unique ability to be able to actually distinguish the presence of the whole virus or would be called the infectious virus in a clinical sample. So most of the other diagnostic tests detect either the internal makeup of the virus called the RNA, the genetic makeup of the virus, or it detects one of the many proteins that are found in the virus. Most of them actually detect a protein that's found inside the virus called a nuclear capsid protein. And we know a couple of tests that look at the spike protein as a detection, but those are small proteins compared to the whole virus. And although they can be good surrogates, they don't give you a direct analysis of the infectious nature of the virus in a particular person or in a group of people or in a population. So we can do that. We can do that at an individual level and because our system is based on cellular communication, it's in our DNA, so to speak. To be part of the cellular communication internet, we can actually add further data on tracing and population-based studies. So we're hoping that this technology can help us at this time in detecting the whole virus, the infectious virus, and give us some idea of the viral load. And we're working towards all that data.

James Di Virgilio:

Now, what is the advantage of having a more accurate coronavirus tests right now? It seems like a lot of people would think, well, look, I go get tested . I'm positive or I'm negative. What's the advantage of your solution?

Vanaja Ragavan:

Well, let's take an example. For instance, if one of our technicians actually developed coronavirus COVID 19 , and we wanted to know when she can come back to work, the current tests tell us whether this virus is present or a part of the virus is present, but it doesn't tell us is she going to be able to transmit this virus? Because we don't know the actual viral count that she possesses. So if we can detect that, we can have a much more accurate picture of when she has the virus and when she's free of the virus. So that's the position that we can bring to the marketplace. There are studies that have shown, for instance, at the RNA can hang around for several days, two weeks after the infection is no longer present, and those are correlated with actual culture of the virus, but that takes several days. And so if you rely purely on the RNA test , sometimes it can take a while to clear the body to clear it, but we can have a much more precise tool that tells us whether the person still has an infection or free of an infection. The other thing is that it's been shown that this virus can live in the presence of the vaccine. It just doesn't cause a severe disease. So shedding of the virus in somebody who has been vaccinated is still an open question and we believe we can add some real value in that particular circumstance too .

James Di Virgilio:

So now if you imagine you mentioned an employer, but perhaps a sports team, which has gotten a lot of press in the past year, they have 20 athletes on the team and they're testing. And right now, if you test positive, you might be out for 14 days or they'll test you every three days. Uh, but like you mentioned, you could keep showing positive test results and potentially not really have a viral load at all, or the opposite is also true. So in your solution, you would get a much more accurate result where you could then confidently send the employee or the athlete back into action, knowing this person is fine because of the heightened accuracy right?

Vanaja Ragavan:

Exactly. And we're sort of focusing a lot on openings , um , colleges and doing the studies on students because they know if somebody's positive, they quarantine for 14 days. And that's pretty awful for a student on a campus to stay within their rooms for 14 days. So we can give a much precise estimate of when that person is no longer infectious or doesn't need to be quarantined. So we can add some precision to this very qualitative world. And that's kind of what we're hoping to do.

James Di Virgilio:

Yeah. And that would obviously be welcome, I think for everyone and anyone who's had to quarantine, as you mentioned, that kind of isolating experience, is this something that we can use now? Can I go use your test, your solution right now?

Vanaja Ragavan:

No, we're not quite ready yet. We're collecting all the data for the FTS approvals . So we're working with some pretty important consultants and so on. So when we get the data together, we'll be happy to let you know James and the Cade Museum. And we'll be happy to let you know when we launch.

James Di Virgilio:

Do you have any loose timeframe. I know you can't know for sure, obviously, but do you have any ideas like this year, next year, longer?

Vanaja Ragavan:

Well, we're hoping to do it by the end of this quarter or the beginning of next quarter. We've solved a lot of the problems with the technology had, we've had some difficult situations. For instance, I need to measure the virus viral load, and it's been really hard for us to get the inactive virus. Most of the methods used for inactivating the virus that we've tested, we've tested about six or seven of them seems to destroy the ability of the virus to bind to our system. It destroys the spike protein, which is kind of what we're binding to our system. So it's been a really difficult task to try and find this nag , the virus mostly because the whole aspect of the scientific basis of this virus is still in its early stages. And so we're trying to work around that system with our consultants.

James Di Virgilio:

And at this point, given the science, you've done the research you've done. It sounds like you feel pretty confident that this solution, not only will it be released rather soon, but that you've gotten over the hurdle of proving the concept, right? It sounds like you feel like the concepts proven this is doing what you think is going to do. Now you're at the one yard line about to kind of finish the task. Is that about an accurate summation of where you are ?

Vanaja Ragavan:

Yes, I think so. We've done a lot of studies on clinical samples and we've shown we can detect the virus. We're going to dig into it further and do some more science on it because I think we want to be a very scientifically based company. And we're working with some of our investigators to determine the correlation between our tests and actual viral culture in the lab. And so we're going to be continuing to do some of that work for both publication and for the scientific community and the medical community. But our basic test shows that we are detecting the virus. And the way we know that is because our system, the one we're using is based on an acoustic wave, detects a mass about the size of the virus. And we have not been able to detect the protein we're detecting the virus. So we're pretty shored and similar systems have been used to detect viruses successfully. And that's in the public literature too.

James Di Virgilio:

And it's your knowledge at this point in time, right? You would be the only, let's say it's a quarter now or two quarters from now in 2021, you would be the only solution out there that would be doing what you're doing.

Vanaja Ragavan:

We believe so, James, you know, it's really hard to know exactly who's working on what, but we believe we are. Yes.

James Di Virgilio:

That's exciting stuff. Now let's take ourselves into the future. And imagine now that this is actually available and I'm able to use it, what does it look like? Am I going to my local doctor? Am I going to like a pharmacy nearby? Am I using it myself? How is this going to work in the real world once it's launched?

Vanaja Ragavan:

Well , as I mentioned earlier, the first aspect of it will be in a laboratory, but while most of the other studies take many hours to a day to get the results back, once we get the sample into the laboratory, we can determine it within 15, 20 minutes and the results can be sent back electronically to your physician or your carrier. What we'll do initially is how the nasal swab that's done sent to a laboratory that can do the testing and send the results back to the provider or the patient. But eventually what we want to do is to do the clinical studies and the technical studies that are needed to become what's called a clear waiver. And that allows us to take our system to the point of care. And so the test can be done and the patient notified within 15, 20 minutes. So that's our ultimate aim though. That'll be our second step in the process because according to the FDA, we need to do some more studies to show that the technology can be worked at a point of care. So we have to do some added studies and we'll be doing that as soon as we launched the laboratory system, consultants have told us that it's better to do it in a two-step process, even with the FDA. So the FDA gets familiar with our technology, and then we do the clear waiver studies afterwards. So they recommended a two-step process.

James Di Virgilio:

Okay. So right now it's July, we're imagining, and I go into my doctor's office and this is just like a normal test. They'd give me and say, we're going to run some tests. We'll send it to the lab. We'll give you your results. But in the next step, really the one I'm sure you're most excited about is going to be the one where I go in my doctor or my physician's assistant, or perhaps down the road, even someone else that has maybe no medical training, if we're getting weighed on the road is able to immediately give me the test and then tell me my results before I even leave. Right. 10 or 15 minutes later.

Vanaja Ragavan:

That's our aim. Yes.

James Di Virgilio:

Okay. So now that we have the idea, which obviously is very exciting, that's something that I think we can all imagine would really help with getting a more accurate way to deal with Corona virus. But let's dig a little bit into how you got here, the origin story. So you went to Harvard, you went to NYU, you're a physician. How did you wind up spending five or six years or even 10 years? I think in your case researching this idea, how did that transition go from practicing physician to entrepreneur innovator, and then someone who's on this path?

Vanaja Ragavan:

It's an interesting life journey. So after I finished medical school and residency and fellowship and all that stuff, I actually ended up working at the food and drug administration. As a medical officer its completely serendipitous. I went to DC, I needed a job and I found one at the FDA and then ended up just loving the work that I did. I have a lot of respect for the FDA. I think they are a highly scientific organization that provide probably some of the best reviews in the world on drugs and devices and attracted they're so well respected that many countries around the world base their entire approval process on the FDA. So it was really thrilling to be there, to be able to help large groups of people rather than an individual patient. And from there, I went on to work at a global pharmaceutical companies. I worked in three large ones. I worked at Wyatt, which is now part of Pfizer at the ventures , which is part of Sanofi-Aventis and Novartis, where I led the therapeutic areas globally. And then eventually I ended up going to a startup in Philadelphia and then I became, what's called an angel investor. So I joined a group in New York called Golden Seeds. And I started a company before, which had exited. And so I was able to take some of that money and put it into angel investment. When I joined a group called Golden Seeds and our mission was to invest in women owned and women run companies. And I became part of their life science due diligence teams. And as part of that, I came across this technology. It was presented by one of the women that came to present to us. And I thought that the technology was really interesting. So I founded a company around it, very unusual technology didn't really know much about it when I started at, of course, since then, I figured out that it isn't in fact unusual it's based on radio frequency chips, as I mentioned. So we tried for a few years in Philadelphia to make this technology work, but eventually found that the most advanced smart device technology was actually in Orlando. It had been developed at the University of Central Florida for NASA. And t hey put in about 10 years of work into it to develop what's called a passive wireless system to go on the space shuttle. What we did is we licensed it from UCF and then we then further advanced it into a sensor for human diagnostics and animal diagnostics, and also other areas like r esearch b ased diagnostics. And so we've been working on that for about four or five years and through the work of some of our brilliant scientists, we were able to solve a lot of problems. As you know, w e're based on r adio f requency chips, which are found in cellular communication. And they're used as acoustic filters in those systems. Y ou probably got about 20 of them in your cell phone, but we had to adapt it to biological use. That's not easy because as you know, electronics and liquids, don't like each other very much, but we figured out how to adapt the system successfully. And we had done exploratory work on diseases like Lyme disease and Influenza. And then when Coronavirus hit, we thought we were an ideal system to detect the virus because we had already had some experience with Influenza. And so we decided to pivot to COVID. And so w e've been working on this since about October a nd now h ave shown a proof of concept that it works. And now we're doing our studies to go to the FDA with our first product.

James Di Virgilio:

And so you're pivoting. It's not really a pivot in your case, actually, when you're just deciding, Hey, our technology can also work for detecting Corona virus, perhaps walk us through at a very high level, what that looks like, how do you get a sample of the virus? How do you test something like that? Like what does that actually look like in the lab? Most of us hear these of this companies testing this , or they're working on this vaccine, but take us behind the curtain here backstage to what it was like to have to try to apply your technology to the coronavirus .

Vanaja Ragavan:

So we had to focus on getting the right reagents . We found out that one of the critical aspects of our system is that we need to add a binding agent to a chip basically. And it's a very tiny little chip. Actually, the volumes needed are in the microliters. So we had to find the reagents that would work. We found out from our previous experience that this system works very well. When the affinity agents like an antibody has a very high affinity for its biomarker . In this case, it would be the SARS cov two virus. So we had to find the antibody. We had to figure out how to put it on the chip. So it bound what's called covalently, which means that it's a tight binding. And then we had to test it with the virus itself in order to determine the output. Now, our output is it's really interesting. It's an electronic readout because it's an electronic readout. And because the affinity reaction is so rapid, our system reacts within seconds really to the binding of this antibody with its virus. And so we had to adapt our software in order to determine the best method to detect this particular reaction, the antibody and the virus. So, you know , we took a little bit of time doing that. We also had to prove that we could detect it many times. And so now we've collected clinical sample data. I would say with about, I don't know , a hundred samples to show that we can determine. And then we had to tweak our software to be able to do the optimal determination. And so now what we have to do is we have to actually do the samples needed for the FDA approval. And that's kind of what we're launching on. So the way the system works is that you would take a sample in this case, it could be a swab of the nasal pharynx. I don't know if your listeners have had a COVID tests , but there's usually a very long stick with a swab at the end and they try to get it from the back of the throat. So we would take that in because it's a dry swab, we need to put a liquid into our system . So we put that into a buffer of some kind. Then a small sample of the buffer is removed and added to our chip. And then we have a reader that actually reads what's going on electronically. And so we will add a graphical user interface that gives instructions on what the user has to do to determine whether the virus is present or not. And in addition to that, what we're trying to do in our first instance is to look at what we call a viral load. I mean, does the patient have a high, low, or medium viral load or no virus at all? So we're trying to make those determinations at the same time. So really once a sample is put on the system, the whole system can do the detection in about 5 to 10 minutes, and then the readout will be provided on the reader on a screen. And then the data is provided to the provider or to the patient.

James Di Virgilio:

And you just described the process really well. Right? What was it like when you first had that moment that, Oh, this is working like we've made this happen? Like this is actually doing what we want it to do. What was that like for you and your team?

Vanaja Ragavan:

I think it was really thrilling. So we have a contract with the Air Force to develop this for the Air Force. And so we had to provide the Air Force with an early milestone where we repeated the sample several times. And when we put that report together, it was approved by the Air Force. That was a really big thrill for us. We were able to do repeated studies and send it to them. So it was an external validation that our system is working. And so we fulfilled our first milestone for the Air Force. And we also told the Air Force, we would ruggedized the system. That means that we take the reader and if we drop it from different levels and so on, it still survives. And we've just finished that. And so we've shown that the system is pretty rugged because if you've got a warfighter carrying something like this to the field, it needs to be rugged. And so now we're doing our final studies to demonstrate how well it works against the standard laboratory tests . So it was a lot of work. We have a great team really, that is sort of half electronics, half biology. And I think it's really interesting to combine these two totally very in fields into one system because we can take advantage of both fields of use the electronics part of it gives us incredible ability to do data analysis, data, distribution, artificial intelligence, and the biology aspect of it allows us to go into lots of different areas that probably could not have been done without a portable system like this. For instance, traumatic brain injury. Somebody has a problem in the field. We can take this and make the diagnosis at the time of the injury or other infections. And so we see a lot of potential for this technology because of the nice marriage of electronics and biology.

James Di Virgilio:

Yeah, its not a one-stop shop like we're spending all of our time today talking about coronavirus, because that is obviously the topic of the day. But as you mentioned, this is going to have wide ranging effects. If it is in fact able to do what you want it to do, especially down the road. If you dream up a world where I could take my cell phone as a layman and potentially use a technology like this to detect things that would affect me and my family down the road, but let's take this in a different direction for a second. So obviously your company has tremendous human capital. You have all sorts of smart people doing all sorts of collaborative things to come together, to create synergy, to craft what you've crafted. It's one of the neatest things about a free idea marketplace, a place where we can come together and share expertise. On the other side of things, you have to have physical capital, you have to have money and resources. How were you able to maintain funding as you're spending all this time researching and gathering ideas and testing ideas to get yourself to the point to you're at now.

Vanaja Ragavan:

So we've done primarily private investors, mostly small investors. A lot of physicians have funded our company, which is good because they see value in it. And then most recently we received a large contract from the Air Force to do this work. So we're still looking for funding. Money is always in need. And so we keep looking for further funding, but that's kind of how we've been funded really at this point.

James Di Virgilio:

And if we imagine a rollout here, logistically, if you're able to begin rolling things out, quarter one, quarter two, quarter three of 2021, whenever that is, what kind of distribution scale are we talking about? We'll just a couple of hospitals or doctors have this. Are you going to be able to send this all over the place? I mean, how many units essentially are we thinking of being able to put out into the world?

Vanaja Ragavan:

Actually, the interesting part of it is the manufacturing, because these chips are made in the billions every year, literally about 2, 3 billion a year. We have a built-in system for expansion, which is really good. And the electronics, as you know, is something that can be done pretty much anywhere in the world. We happen to focus in on Germany because we found that a lot of our base technology is well-established there. So our fabrication system is in dressed in, and they'll be doing all of our worldwide fabrication. They will probably use facilities elsewhere too , but they'll coordinate that. And our electronics is also made in Germany, in Munich. That is the heart of the electronics, but the other electronic components will be designed and put together in the US so because both the chip is commonly available on the electronics is commonly available. That is not a rate limiting factor for us on the biology side. On the cartridge side, we've had to build some cartridges that work with the system because the system is sensitive to external pressures. That's why it was developed for NASA to be able to detect external strain and stress on the spaceship and temperature. So we have to account for that with our cartridge and with our software. And so we are working with some pretty high level companies in the US to solve those problems. And I think at that point, then we'll have to coordinate and put the entire manufacturing process together. So w e're working on that now, and we'll have a final solution by the time we launch. I think the system can be taken anywhere, maybe not in the first instance, but in the second instance, when we do a point of care, we're hoping we can take advantage of the s cale-up available for the electronics industry and the biological industry to be able to provide what's needed.

James Di Virgilio:

And you can imagine an incredible application for so much of the world, especially if you're like me. And you'd like to travel around the world in places where the nearest hospital is not close to you at all right. And you're traveling or you're somewhere, or you're in a third world country that just doesn't have access to high level medical care, but they may have a cell phone. And again, this is in the future, but to have an ability to detect some of these things would certainly be a game changer. So let's take us down to the end here and close the curtain on this with this question, why do this, why launch a company? Why leave a day-to-day practice with the FDA? Why take all this risk, spend all this time? What motivated you to do this?

Vanaja Ragavan:

I don't know if I have a real answer except that I wanted to use my knowledge of business and medicine to create something that could help people. And I didn't quite understand that technology when I started. So maybe it was a little [inaudible] when I started, but I think I've learned a lot and it's just allowed me to get into an area that I would never even have an emission doing. Otherwise, the people I've met, the knowledge I've gained and the collaborations that I've been able to pull together has been a real thrill and the persistence to try and find the smartest technology, the best available, and the people that make it happen. It really is what keeps me motivated. And the ability to help people. We can truly help people with this. I think so.

James Di Virgilio:

And I think thats what's interesting is we live in an ever fractured world at times, with how they feel about free market versus essentially planned market versus a bunch of other economic topics that interest me a lot in my daily life. But what you said is what I come across the most frequently and discussing things like these as entrepreneurs. And it's almost always, I wanted to use my skillset , my knowledge, my expertise, to help others, to help my community, to help the world around me. And that's often the origin of the idea, which is, I think so rewarding. So immensely deep, it's connecting you to your fellow people and allowing you to obviously change the world for the better, which I think is one of the great things about what the Cade celebrates here. What I celebrate, what you're celebrating in your daily life, not only as a founder of your company, but also as you mentioned, an angel investor funding, other ideas. So I wanted to thank you for coming on the show today. Obviously we're very excited for what you're doing and how you're trying to help the world around us. Once again, our guest today was Dr. Vanaja Ragavan the founder, president and CEO of Avianna Molecular Technologies. You can find her on the web. You can find her on LinkedIn. Just thank you so much for being with us today. We really enjoyed having you.

Vanaja Ragavan:

Thank you, James. We've enjoyed learning more about the Cade Museum, and I think we were one of its awardees this year.

James Di Virgilio:

Indeed, you were. And congratulations on your success for that. For Radio Cade , I'm James Di Virgilio.

Outro:

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida. This podcast episodes host was James Di Virgilio and Ellie Thom coordinates inventor interviews , podcasts are recorded at Heartwood Soundstage and edited and mixed by Bob McPeak. The Radio Cade theme song was produced and performed by Tracy Collins and features violinists, Jacob Lawson.