 Dr. LaBear is the executive director of ASU's Biodesign Institute and one of the nation's foremost investigators in the field of personalized diagnostics. In response to the coronavirus pandemic, Dr. LaBear quickly repurposed expertise, equipment and personnel to accelerate testing. The new ASU Biodesign clinical testing laboratory developed a federally authorized diagnostic test known commercially as a QPCR to detect coronavirus for individuals who may have been exposed to the virus. This new lab gained CLIA certification for testing nasal swab samples and then became the first in the country to run saliva tests for coronavirus for the public. Dr. LaBear earned his medical degree and a PhD in biochemistry and biophysics from the University of California, San Francisco. He completed his medical residency at the Brigham and Women's Hospital and a clinical fellowship in oncology at the Dana-Farber Cancer Institute where he also founded the Harvard Institute of Proteomics. So Dr. LaBear, I will turn it over to you. Hi. Well, good morning, everybody. This is a small enough group, so please don't hesitate if you need to interrupt me at some point because I'm not clear or you have a question. I think it looks like you're going to run the slides then. Or do am I doing? Correct. I'll be advancing them for you. Okay. Why don't you go ahead and advance the slide? All right. So the first thing I'm going to say, and I know probably many of you have heard all this before, but just to remind you, what has made the SARS-CoV-2 virus, that's the name of the virus, so virulent and so problematic is that it has three characteristics. We say that it has sort of won the trifecta here. The first is severity, and it's kind of a maddening aspect of its severity because while it clearly kills people, we are losing countless people every single day, two people a minute, something to that effect. It also is very mild on other people, and I think that has been a challenge for this virus. If this virus made everybody sick, if it made everybody get a bad flu, you'd see a lot better behavior from everyone because they would know they don't want to get it. Unfortunately, better than 80% of people don't feel anything, or fortunately, I suppose, and so they're less worried about it. But it is 10 times worse than the flu in terms of mortality. It is a severe virus for many people. The second is it spreads incredibly fast. We'll come back to this, but it spreads by airborne transmission, which makes it one of the worst ways of spreading because it's one of the hardest ways to control, and it is stealthy. And by stealthy, I mean that the virus spreads from people who don't know they're sick. And that's what's been one of the biggest challenges. There are two other viruses in this family of viruses that are also deadly. You've heard of the SARS virus, and you've heard of the MERS virus. Those are both deadly, but they've really all told killed less than maybe tens of thousands of people total, not like the near million that we've seen now. And that's because when people get those viruses, they're sick when they're spreading it, so they know they're ill. This one is challenging because people spread it and they don't know they're ill. And I think this comes back to the reason why some testing in the schools is going to be so important is the only way to find out if somebody is ill is to test them. So let's go to the next slide. This is just to remind us that this virus spreads exponentially. Each node here can give the virus to two or three people roughly. That's what the numbers suggest in the context of this virus. Now, it's not always true that one person gives it to three other people and that person gets to three other people. Sometimes one person gives it to 10 people and another person doesn't give it to anybody. But it's also important to remember that this spread doesn't happen in an instant. So if you click forward here, you're going to see that this first person will spread it to one person, to two people, and then go ahead, click again, and then it sort of spreads over time. And I emphasize this part because if we can interrupt this whole chain, then we limit the number of people that get the virus. And that's the goal here. Limiting the number of people that get the virus does a lot of things for us. First of all, it reduces the chance that somebody will get severely ill and die from it. We don't want that at all. But it also limits the overall burden of virus in the community. And the more virus that's around in our community, the more opportunities the virus has to mutate and form strains that are more difficult to manage. We really don't want to become a culture container for this virus and let it grow to huge numbers. So we want to stop it before it has a chance to spread. So if you go to the next slide. So this just reminds us that this virus spreads by an airborne route. The virus surfs along the droplets of saliva that come out of our mouths when we speak and breathe. And I know we don't always think about that. But when we speak, and this has been documented. We produce about 2,600 droplets per second. Per second. So that's a lot of droplets that are coming out of our mouths as we're talking. That means that as we converse with somebody, we're surrounded by a cloud of our own moisture. And that becomes air that the other person breathes. And it's the opportunity for the virus to ride along those droplets and infect the other person. So there's been a lot of talk about this sort of six foot spacing. And I think we're all familiar with that. And it is important. But keep in mind that that number is sort of arbitrary. It came from studies done in the 1930s. So almost a century ago, when they couldn't even measure the size of the droplets that this virus is traveling on. Those larger droplets they could measure back then fall to the floor in three to six feet. But the droplets that the virus we know now travels on can linger in the air for a while, minutes even, and in some cases even longer than that. So it's around. The virus is out. It's in the air. It floats around. And all of this, I think you can see where I'm heading here, is that mask wearing is really crucial. We have clearly documented that masks prevent these things from getting into our respiratory systems and infecting us. And the key, of course, is that you want a mask on both ends. You want a mask on the person speaking and a mask on the person listening. And that adds sort of two layers of filter that prevent the virus from ever making it from person A to person B. And many, many documented cases of people where there's been an infected person in the room, but both people are wearing masks and the other person doesn't get infected. So masks clearly work. OK, we can go to the next slide. So ASU has taken what we call an offensive strategy against the virus. It's great to do physical distancing. We talked about that. We talked about the importance of mask wearing. That's not enough. The virus is still spreading despite that. And so part of our strategy has been testing. And we think that testing is important not only because it helped us identify those people who are ill and then allows us to get them out of circulation until they get better so that they don't have an opportunity to spread the virus. But it also actually alters behavior. It actually helps encourage people, believe it or not, to avoid spread. And I think ASU is a good example of that. We randomly test the students in our school. And every week, a number of them get an email telling them that it's their turn to get tested. And we have seen transmission rates among our students at a very low level, far lower than in the community at large. And so we've had much less spread within the ASU community because we do this random testing. So I think that testing is itself an intervention. It prevents the spread of the virus. And it helps us identify quickly people who need to get separated until they get better. So that's part of the reason we're using the strategy. Let's go to the next slide. So our lab set up a clinical testing scheme. We use technology that we already had for another purpose. We pivoted it to do what's called this QPCR test. I'm going to come back to testing in a minute. Our first tests were at the beginning of April last year. And it has only grown since then. Today, typically in a day, we will do anywhere between 5,000 and 7,000 tests often. And as Tamara mentioned earlier, we're doing them all over the state of Arizona thanks to the state of Arizona where those are underwritten by the Arizona Department of Health. So they are free to the public. And we have used saliva for a variety of reasons, in large part because it is the medium by which this virus spreads. And so it's the most relevant source of sample to look at. It is as accurate as the nasal testing. And it's a lot easier to get the sample. It's less traumatic. I think all you do is spit through a straw into a tube. And so we were able to collect a lot more samples that way. All right, let's go to the next slide. So I'm going to briefly remind you of the different kinds of tests that there are out there. I'm going to start on the right-hand side here with the antibody test just so that we can dismiss it. The antibody test is a test that's used to determine if you had the virus in the past. Your antibodies won't be apparent until about 10 days or 14 days after you get infected. So antibody tests are not in any way helpful in determining if someone is currently infected with the virus. Really what they tell you is that sometime in the past that person had the virus. There are three other tests listed here for testing whether someone is currently infected. The LAMP rapid home test is a very specific test. It's one that you need to get a prescription for. I'm not going to really talk about that. It is an amplification test. The rapid test, the antigen test, you've probably heard about that one. That one is advantage is that you can actually run the assay very quickly. The assay that we do in our lab takes a couple hours to run. This particular assay takes only 15 minutes to run. However, if you want to do a lot, a lot of samples, you have to line them up 15 minutes after each 15 minutes so it's not always as fast as it sounds. The bigger problem with the antigen test is while it's useful in people who are sick and who feel ill, it is not useful in people who are not. If you don't have symptoms, there's a very good chance that this test will not detect the virus in you. And that's a huge problem because one of the main reasons for testing is to determine those people who are ill and who don't know they're ill. That's what we're after here. So that's why we focus on this RT-PCR test, the one that we use for the saliva testing. It is the most accurate test out there for detecting the virus. It measures the RNA in the virus. That's the genetic material in the virus. We have a machine that amplifies that RNA. The test we use can detect down to around 200 virus particles per sample. Keep in mind that most people when they're ill have around 10,000 virus particles per sample. So it's quite sensitive test. The test we use tests for three viral genes. So there is virtually zero chance of a false positive. When we get a result, it's very clearly that there was virus in that sample. It is also important to remember that when you collect your sample is important in terms of when the test will be accurate. If you got infected today, let's say you got exposed today with the virus and we tested you on Monday, your test would likely be negative because it takes about four to five days for the virus in your body to amplify enough to be detectable by a test. So you may have to get tested again. If we tested you by Wednesday or Thursday, your test would be positive. And we've seen this in people already. So even though the test is quite accurate, it does depend on when you collect the sample from the person and where they are relative to when they got exposed to the virus. All right, let's go to the next thing. So I'm not gonna spend a lot of time on this. The ASU team has done a spectacular job in sort of setting up a whole pathway for how to collect samples, how to run the samples and how to get information back to people. We've got an integrated database that handles all of this. It is what's called HIPAA compliant database. For those of you who don't know what that means, it means that it respects the privacy of the individual. So it's very secure database where nobody else can see anyone's medical result. Basically every person creates his or her own portal, you log into your own portal and you get your result that way. So it is true and I will tell you that by law, all the results that we get get reported to the state and that is true for a pandemic like this. When we get results, they do get reported to the state but the results are private and nobody else can look at it. And this database can be accessed by your cell phone or by your computer. So people log in through that, they set up their time for their test, they run the test and then they get their result back from their own portal. Okay, next slide. I'm briefly gonna mention some variants because they're on everybody's mind right now. I will first mention that the reason there are so many variants is because there's so much virus. The more virus that's around, the more variants that are gonna occur. Biology is like that, whenever you make a copy of a genome or when any organism replicates, errors occur in the DNA copying and new variations will appear. There are several that are appearing now that have functionally different characteristics. The strain from the UK would commonly called B117 appears to be a variant that is much more transmissible than the virus that we've been dealing with here. The last data I have heard is that it's no more severe, it is just more transmissible. We do know that the UK strain, the B117 strain does respond to the vaccine, it is still a targetable by the vaccine that we're using in the US. Nonetheless, if it were to take hold here in Arizona, for example, it would mean that we would need to reach a higher number of vaccination to achieve herd immunity because the more transmissible the virus is, the higher you have to go for herd immunity. The South African strain, which is called the B1351, a bit more troublesome, that particular strain looks like it does affect the vaccine efficacy. And so we really have to keep an eye out on that one. So far it has not been reported in the US, but we really would prefer not to get it here. Obviously we want to deal with strains that are resistant. And the Brazilian strain is yet another strain. I'm not aware that it evades the immune system yet, I need to look more into that. But again, all of these strains, the more transmissible they are, the more virus we're gonna have in our community, we really don't want that. We want to reduce the burden of virus in the community so that we can get to herd immunity quicker and we can get back to our normal lives. Keep in mind that the emergence of strains is a reason to get vaccinated. The more vaccine we do, the fewer cases of virus we have, the less we have to worry about these other strains. And so all of this points to the need to get vaccination done. Next slide. So Tamara alluded to this already. The ASU does a lot of mass testing at statewide sites. Cardinal Stadium is one of them. I think the Muni Stadium is another. I think we may have other places in Mesa and Chandler and others where we're now doing offering testing. The team there is just phenomenal. We've only heard great things from people who've used them. Typically from the time you pull up until the time you're out, it'll be 15 minutes at most. Most people find that it goes very quickly, especially if you've scheduled it at a reasonable time. You'll see it goes very quickly. The team is very quick. You just collect the sample with the straw in your car and then you're out. So I think these are the sites where the teachers would be able to go to get their tests done. All right, the next one. Right, and then we've really said this already. I'm not gonna belabor this. I think I've covered all these points. We were the first to run saliva testing. I think we're still the only ones running. Maybe that's not true anymore. I don't know, but for a long time, we were the only ones doing saliva testing in Arizona and certainly the first in the country to do public testing using saliva. So it's gone very well overall. We've been very happy with outcomes there. I think this is most of what I have. Is there anything else on the next slide? This is just the instructions to collect the saliva. We use the drinking straw primarily to ensure that we get saliva. What we don't want is phlegm. We don't want snot. We don't want any other secretions up there. We're really just the spit in your mouth is what we're looking for. And the straw does a good job of ensuring we get that. That's crucial for our instruments to work. If they get the wrong substance, our instruments can't run the test. And it won't be valid anyway. But that's all it is. You just spit into tube. We actually have a video available on our website that shows pictures of sour food to help you produce saliva in your mouth if you have trouble doing that. So if you ever need that, we have that available. Next slide. And this just summarizes kind of where we're at. As Tamara mentioned, we're close to 600,000 tests now, well over a half a million. Our turnaround time is quick. Typically people will get their answer within 30 hours of when they do the tests. So sometime on the day after you get the test, you'll get your answer back. We run tests all of the state of Arizona, including for the Department of Health Services. So it's a well-oiled instrument machine. All right, next. Don't need to tell you that right now things are not great in Arizona. We have a really high count number in the state. We are leading the country in terms of transmission. There's a bit of a hint that it's leveling off. I wouldn't start celebrating right now. I tell people that if you're in a car that's out of control at 140 miles an hour and you managed to wrestle it back to 130 miles an hour, you're still going way faster than you wanna be going. And at 7,000 new cases a day, we're going way faster than we wanna be going in Arizona. We don't want that many new cases a day. So right now, the number of deaths due to COVID in a 12 month window outpaces cancer. It is the number two slot. Yeah, here you go. These are all deaths of COVID-19. And it is now the number two killer in the state and probably in several days, it will become the number one killer in the state. It will be the leading cause of death in Arizona over all other causes of death in a 12 month window. So it's a serious illness. Next slide. I'm not gonna go into this. If you're welcome to come to our website, which tracks trends, we post data every day in a variety of different charts and even some tables about what's happening currently in Arizona. So we track the different counties. We track how we compare to the nation and so on. And happy to help anybody here who wants to follow that information. It's kind of a useful way to know what's going on in the state. I think that's mostly what I have. Yeah, so I'll stop there. And if there are any questions, I think I can answer them unless we're short for time. You know, Dr. LaBear, one of the questions that people have been asking, and we're gonna have people covering this, but maybe you can speak to this as well as why is it important to continue testing as people are becoming vaccinated, particularly in schools? Right, right. Well, a couple reasons there. So first of all, the number of people who've been vaccinated right now is tiny compared to the total population. So the amount of vaccination we've got so far is really not significant in terms of overall statistics in the state. That's really important to remember. It's great that we're hitting people who are at risk of going to the hospital because we can ease up the burden in our hospitals, but there's still widespread virus in the community. Secondly, we don't yet know if vaccines prevent people from getting and spreading infection. We do know the vaccines do prevent people from getting seriously ill. And of course that's the most important thing, but they still might be able to spread virus. And so the best way to find out if people are carrying virus, and especially if they don't know it, is to do testing. It's the only way we know of finding out where the virus is. Great, thank you so much, Dr. LaBear. We appreciate you, and we hope you have a wonderful rest of your day.