You’re listening to a press conference from the Harvard T.H. Chan School of Public Health with Michael Mina, assistant professor of epidemiology and a faculty member in the Center for Communicable Disease Dynamics. This call was recorded at 12:30 p.m. Eastern Time on Friday, August 7th.
MODERATOR: Dr. Mina, do you have any opening remarks?
MICHAEL MINA: I might eventually, depending what questions come in. I definitely want to take this opportunity to talk about some of these rapid tests and the federal regulations that are inhibiting the introduction of them, and just how they can effectively be akin to having a vaccine that was introduced tomorrow. So hopefully I’ll get questions about it, but if not, I’ll probably stop in the middle and start talking about it.
MODERATOR: Great. Thank you, Dr. Mina. First question.
Q: Can you hear me OK?
Q: Well, Dr. Mina, I’m curious, what does it mean when we’re seeing testing fall in a state and we’re also seeing positivity rates fall in that state, too? Are we not getting a full picture of the virus if it’s spreading? Or do things potentially look more positive than they are? Or is that not the case?
MICHAEL MINA: So the question is, if you see the numbers of tests being performed in a state go down and the positivity rate go down as well?
MICHAEL MINA: That generally implies, and this comes with huge caveats, but that implies in any way that the case numbers are actually falling. This happens in Massachusetts, for example, where as cases start to come down, people begin to loosen up on terms of the craze to get tested, so you end up getting fewer and fewer people getting tested, which isn’t always a bad thing. And this is really where we want to get. We want society to have such a low overall prevalence of disease and infections that, you know, in an ideal world, we would have no more infections and we’d be able to stop testing. Of course, we’re not getting there any time soon. New Zealand was able to get there, although I presume they’re still testing. So when they’re both going down, it usually means that the cases are truly going down. When testing is going up and the rate of new infections and the proportion positive are going down, it’s very difficult to tell if that’s just because testing is going up or because cases are actually going down. And we’ve been trying to work on ways to sort of decipher that in the research space. But does that answer your question?
Q: No, it definitely does. And as a follow up, maybe this will get into what you were kind of hinting at you wanted to talk about earlier, but what is the dream testing scenario for you, for the US? Is it people getting regular tests often regardless of symptoms, or what does that look like for us?
MICHAEL MINA: Yeah. So I’ll take this time now. I’ll try not to speak very long. So if you guys get sick of hearing me talk, just chime in and tell me to stop talking. The status right now, we have for the entirety of this epidemic, we keep trying to take diagnostic tests and use them for public health surveillance. Our diagnostic tests or are limited, they are necessarily limited. They have to be extremely high quality in terms of their precision and accuracy for what they are trying to get at. They’re usually running diagnostic laboratories because of that, so that means they literally have to get bottlenecked and funneled through doorways to get into a lab, literally. We’re starting to see distributed types of tests like Vidal and Abbott now, BD, and a few others.
And these are helping. But these aren’t helping at the level of public health. They are helping to just create more diagnostic tools. What I’m proposing as a way to use testing to our advantage, is a way not to just keep diagnosing people. Because diagnosing people doesn’t do much for public health good to actually stop the outbreak. In the same way that we know that, would anyone care if we could give you a vaccine that worked for two days? Would we be running to get it? No, we would understand that a vaccine that only works for two days is not a useful vaccine. We would want a vaccine that works for a year or 10 years and that would be a useful vaccine. And so we keep trying to use these diagnostic tools that just tell us about what’s going on once every couple of months when they maybe get tested, and it’s doing nothing to stop transmission chains. In fact, I would say that PCR, using it as a diagnostic tool not only offers very little for breaking transmission chains, but it actually is putting us down the wrong road because PCR remains positive long after somebody has been infected with the virus and transmitting the virus. It’s why the CDC comes out and says you don’t necessarily need a negative result to come out of quarantine after you’ve been positive, just wait 10 days, because if most people wait until they’re actually negative on a PCR test, it could be weeks or months before they turn negative.
But we recognize that they’re not a danger to society after about 10 days, because they’re transmissible period is done and they just have RNA that’s residing in their nasopharynx in the same way that people’s DNA is in their hair. If you find somebody’s piece of hair, it doesn’t mean the person is in front of you. It’s just their piece of hair. That’s the same thing that’s happening here. And so what I think we need to do is change the target. We need to not use PCR positivity status as our public health metric, because what it means is that we’re contact tracing millions of people who don’t need to be contact traced because they were actually infectious weeks ago. We’re also quarantining millions of Americans for 10 or 14 days who haven’t been transmitting for weeks by the time they got their results. And this isn’t even taking into account the fact that result times are so delayed. So what I would like to see happen is to start using testing out of the diagnostic realm and as a true public health tool to break transmission chains. In the same way that we know that masks can serve to decrease transmission, I want to use tests to decrease transmission. And the way to do that is to use cheap tests that are highly accurate to detect somebody at the moment they’re transmitting, but maybe they don’t look accurate because we’re comparing them against PCR positivity, which stays positive for so long after transmission. So I want these tests that will tell somebody that they’re transmitting at the time that they’re transmitting. And people can act on it because they’re getting immediate results. I want them to take it every single day or every other day. These can exist. There can be one dollar a day tests. We need a project warp speed for these tests. And the reason is, we have put so much effort into vaccines and therapeutics, and we’ve put trillions of dollars in stimulus for the country. We have a workable solution today, that if the federal government actually said, we will put a billion dollars into really pushing the technology for one dollar paper strip tests that can be printed in the millions, which they can be, and get a package of 50 in every American’s hands over the next month. Or not even every American. It could just be in Texas and Arizona and Florida right now because those are the states that are seeding infections to other states.
So really take all of this as a big public health umbrella approach. And if we can do that, if we can get a test that everyone wakes up, just like they put in their contact lenses, they take a test. And if it turns positive, they stay home and they take a test the next day and they stay home until the test turns negative, or for some set number of days, maybe seven days and that’s it. That alone, if everyone’s doing it, or even just a majority of people are doing it, then it will stop the vast majority of transmission and it will cause these outbreaks to disappear in a matter of weeks. We don’t have to wait for a vaccine when we can essentially think of these as development of artificial herd immunity. We know that we don’t have to get 100 percent vaccinated to stop transmission of this virus. We just need around 50 or 60 percent. The same thing goes here. But because they are tests that are giving people information about themselves, the hold up is that they’re defined as diagnostic tests. And as diagnostic tests, if you’re comparing them against PCR, they’re going to look bad. And the FDA is not going to necessarily approve them for at home use. What I’m calling for is that there is a national movement to get these no longer defined as a diagnostic test, but a public health tool in the same way that masks are public health tools, that checking somebody’s fever is a public health tool. It’s a screening mechanism at for breaking transmission chains. And if we can get it outside of going through the CMS pipeline that puts them into the FDA and they’d become overseen, for example, by CDC. And maybe CDC comes out with some certification program for the tests, to say this is a good test.,this is not a good test for this use. We could truly build that up. And if the federal government would create a project warp speed surrounding this effort, we don’t need a vaccine tomorrow. We can buy ourselves, potentially years of time before we need a vaccine. For one tenth of the recent stimulus, we could get one of these tests in everybody’s hand every single day for months or a year or so. And and that would stop transmission. Doesn’t need to be a hundred percent. It just needs to be out to a lot of people.
There’s regulatory reasons why they aren’t out yet. And it’s all surrounding just red tape. But we’re allowing red tape in this archaic view of what defines – in this country, we have so defunded and under appreciated public health for so many years that we literally don’t have a recognition of the fact that there could be a test whose main goal is public health and not clinical medicine. Everything is wrapped up in insurance reimbursements and FDA regulations as diagnostics that it takes a whole rethinking of what a test that somebody might use looks like and how it’s defined. And in this case, I wanted to find as a public health tool that a State Department of Public Health or the CDC can push forward and say this is just like a vaccine, how we’re going to deal with this epidemic. And if we can do that, we could potentially have or greatly reduce, maybe by 90 or 95 percent, reduce transmission in this country in the next few weeks if everyone could have one of these tests tomorrow. Of course, that’s not at the moment possible, but it could be if the federal government treated this with the same urgency that they are treating a vaccine which may or may not even work. I forgot what the initial question was?
Q: No, no, that was great.Thanks so much. It’s been really interesting.
MODERATOR: Next question.
Q: Very early on in the epidemic, the Gates Foundation was proposing to come out with a system, based on the Seattle flu study, that would allow people to swab themselves at home. It’s still a PCR test. They were wanting to roll it out on a large scale and then it just suddenly came to a screeching halt. My impression is that it’s wrapped up in this FDA approval process. Do you have any idea what’s going on with that? And do you see something like that as a viable alternative, even though it’s PCR based?
MICHAEL MINA: I don’t see it as an alternative. All that would do is clog up our laboratories more. If we started to have millions of Americans taking it, using at home swabs that need to be sent into a laboratory or any sort of centralized location, and we already have two week delays in some places for getting results back, it would hamstring the whole diagnostic effort. And this is why we really need to figure out how to distribute these types of tests, get them out of the laboratory and preserve the laboratory space in a laboratory environment for for true diagnostics. Somebody is at the doctor’s office or the hospital because they are sick. They need a result back quickly. We have to separate these two ideas.
Now, if there was some new technology that came out to really be able to massively take in millions and millions of samples into a centralized lab, that could work. But still, one of the only reasons that this approach is really working that I’m suggesting, is because it gives you real time information. And so that initial effort to sort of have home swabs, which we’re still pushing for various reasons, but that was, again, just part of this overall thinking of trying to fit a square peg in a round hole. Trying to sort of get co-op diagnostics for public health surveillance. We’ve never dealt with such a dire situation diagnostically or testing wise as we are currently, that we we just don’t have the capacity. We can’t build the capacity to do 100 million tests a day in our laboratories in the United States. So I do think, though, that was devastating to see that come crashing to a halt. To your point, though, and that was wrapped up in FDA. And it frustrates me to no end when I’ve talked to senators. I’ve talked to people close to the White House. I’ve talked to congressmen. I’ve talked to heads of states of many other countries, and everyone says, why aren’t you doing this already? My answer is literally that it is illegal to do this right now. I mean, it’s insane that this is something that could stop outbreaks and epidemics as a public health tool. And there is no clear path to legally introduce these tests without the company making them getting shut down because they are being viewed as a diagnostic. And and because they’re being viewed as a diagnostic, using fairly archaic metrics to what is the approval metric to achieve. It’s a problem. And it pains me to say that we have a tool that the federal government could build, that companies alone could build, if needed, but I don’t think they should all fall on 3 person companies or 10 person companies. But it’s illegal. It’s crazy. It’s illegal to save lives right now. And it’s simplifying it a little bit. But that’s pretty much the message.
MODERATOR: Do you have a follow up?
Q: I do. So when you’re talking about it being illegal, are you talking about this swab test or are you talking about these other types of tests that you were referring to earlier? And you said that you’re still pushing for the swab test? In what application?
MICHAEL MINA: Yeah. Until we get a rapid paper strip type of test into everyone’s home, you still need to figure out how to keep people safe and have some semblance of public health testing. And so I do think at home testing, if we can do it, and it shouldn’t be hard, it’s already been approved by some. So the moment you say that at home testing, taking a swab is OK for one company, it should just be OK. And I think there’s been this confusion about the actual test in the lab and the swab collection. And as soon as one person has said that it’s okay for people to swab at home, then everyone should have a clear pathway to use their tests for people to swab at home. I think there’s a real danger there. It would have to be controlled, the number of swabs that are able to be mailed out or something at any given time. But both of these at the moment, in my capacity as running a laboratory at a hospital, I couldn’t just mail out a bunch of swabs today and tell people, OK, this is your 10 swabs to use over the next two weeks. Mail them back to me and we’ll test them. That would not be illegal right now under our current rules. And if that’s a better way to get tests out to disadvantaged people who can’t necessarily drive to a drive thru than we should be doing it. And there shouldn’t be that kind of red tape that exists. This has been the story throughout this whole epidemic. It initially came from a good place, which was this whole notion of an EUA approval process was designed to ensure that the tests that were being used were accurate when the consequences of having a false diagnosis are very grave. So for something like Ebola, that makes a lot of sense. You don’t want to miss as a case of Ebola and you don’t want to tell somebody that they have Ebola when they don’t.
But with a virus like this that’s now widespread, we need to start thinking of different approaches. And the FDA alone can’t be dealing with every EUA application as it is. People are just applying and they’re not getting results back, they’re not getting comments on their EUA’s back to the FDA for months. So it’s just holding things up. And we’d just have to rethink the system at this point. The virus is widespread now. Get rid of the EUA, we don’t have EUA’s for flu, for example. Allow different laboratories to just go forward as long as they have the expertise to do it, to do it, and still have some regulatory process. Right now, in some ways, there is no regulatory process in the labs because at the moment, essentially, you just have to submit your EUA application and you can start testing people. You don’t get a response by your EUA application for potentially months. So in some ways it’s de-regulated anyway, but it’s just creating a huge barrier. But they have come down and said that would until you get your EUA approval, you can’t send people kits to use at home. We know that the technology and tools work. So we’re just continuing to be stuck in this regulatory landscape that was never designed for a public health emergency. We’re not treating this like a true public health emergency and frankly, like a true national crisis. We’re treating it as though it’s just another day and with red tape and regulation, and I’m usually not against regulation in this way, but I think it’s just gotten so extreme here. And it’s truly been hindering every step of the way our ability to test our way out of this fire since February.
MODERATOR: You all set?
Q: I am, thank you so much.
MODERATOR: Next question.
Q: Hi, Michael, how are you doing? Thanks for taking questions on this. I wanted to get a few more details about these basic paper tests. So what is the actual status of their development? I mean, are they kind of proven in the lab but no manufacturers have taken them up yet, or are manufacturers ready to go, and it’s literally just waiting for these approvals? What’s the status of these? How soon could they be in people’s homes?
MICHAEL MINA: Yes, I’ll answer that in two different ways. So the first, the status is these tests do exist. They are in clinical trials. They exist in paper format. I have some here at my house that we were just testing in the laboratory. So they exist right now. Even a small company could build a million of them this week. And that’s a small company. So they actually exist. But I get this question a lot. What is the status? How close are they and everything? And this isn’t any offense to the question or to you or anything. I’m tired of that question being asked, because what I would like to be asked is, does the technology exist? The answer to that would be a clear yes. What should the federal government be doing to ensure that they create a federal response to produce these. The tests exist, but truly, some of the companies that I’m talking to are three person companies, and the fact that we’re even talking about a product that could potentially change the course of this pandemic. That we’re talking about a company that’s comprised of three people is ridiculous.
The government should be recognizing the potential for these tools as a core technology and should be enlisting the full might of the NIH in the same way that the NIH has the vaccine research center. And they should be pushing on the major manufacturers, whether it’s diagnostic manufacturers or companies like 3M, and I know 3M is potentially working on it, but they got a measly five hundred thousand dollars from the government. That should have been a five billion dollar investment from the government to ensure that 3M can produce these tests at scale. And so the question shouldn’t be, where are we and what can we do? The question should be where can we be in three weeks if the government right now put two billion dollars into it? And that’s what I would like to answer. And if you ask me that, I would say if the government right now put a billion or two billion dollars into even just getting out of any of the individual companies, but just bringing these companies together, bringing the best minds in the country or the world together to sit in a room for a month and figure out the optimal task, get structural biologists, get whoever needs to be there to figure out how to make these tests as optimal as possible and then just start producing them. And the reason why it’s doable is because unlike a vaccine, this isn’t a tough technology to build. We’re pretty much there. We have workable tools, but we could optimize them even more and start and get the cost per test down even more if it wasn’t a three person company. But it was a massive company that has economy of scale. You could maybe build these tests at a reagent cost of 50 cents a piece or less. I mean, I think that they can get down to pennies in reality when we think of the true material cost. And so if they’re being produced in the tens or hundreds of millions, then everything changes. But we’re treating it as though this is just business as usual. We’re going to let the free market reign. We’re going to let capitalistic sort of pressures and forces work. And hopefully the first three or ten person company will rise to the top. It’s really insane when I think about it.
Q: How about the intermediate scenario of regulatory approval? But over government support? Not the billion dollars. How rapidly could these three people companies scale up? And without that support, how many tests could we have in a month?
MICHAEL MINA: Yeah. I think they could start producing them with small companies and small manufacturing plants. They could start producing a million a week. If they go to slightly larger manufacturing plants, if the regulatory hurdles were completely gone and the buyers were there, which I think they would be, they could find the manufacturing to go to 10 million a week. And these are still without without the big guns coming in and participating. So these are truly scalable solutions.
Q: Forgive me for a third question, but as far as uptake on the public side, would you need major public health figures pushing this as a viable strategy?
MICHAEL MINA: I think we would want public health oversight, like the CDC, to give a stamp of approval on different companies as they come out and in sort of a regulatory framework like the FDA has. But we would want it to be focused on metrics that reflect public health use and not diagnostic use. So if we could go in that direction, I think in this country, we would have such a major demand that probably half of the country would, especially state public health, states appropriated from funds to subsidize them, I think we would have huge demand for them, which would push. We don’t have to have 100 percent. Again, the moment we can get away from thinking about this as an individual level response and test, to thinking about it as a mechanism to suppress the overall incidence of virus in the population, then it becomes, we can really relax. What these tests need to do, if they do nothing more than stop the super spreading events, then that would reduce transmission potentially by 70 percent. We can stop the 20 percent of events that are super spreaders. We would stop 80 percent or so of infections potentially. That’s what the models show. So we don’t need everyone to take these up. If we had 50 percent of the people in a given community using these on a daily or every other day basis, we would massively drop transmission across the population. And so I think the demand would be there. I think if the federal government or state governments jumped in and subsidize it, made sure that every American had enough to use one every day or two at 50 cents or dollar a piece, then that would be even better.
Q: Thank you very much.
MODERATOR: Next question.
Q: Hey, thanks for taking my question. You and a lot of other experts have really sort of been pushing this idea of rapid tests for a few weeks now, and I’m wondering if on the regulatory side, if you’ve seen any progress being made, if you feel like the FDA might bend. How do you sort of see this playing out? And has anything sort of changed so far?
MICHAEL MINA: So there’s been a lot of movement, I would say, I think that there’s a groundswell of support. I don’t think of this as a last ditch effort. I think of this as a very reasonable, simple effort and one that is dead simple. It just makes sense. So I think that that is leading to a groundswell of support at the federal level. A lot of senators have called me up and signed on and said, how can I help? Who can I talk to? I hosted a pretty large roundtable meeting just yesterday with the mayors of some of America’s major cities, as well as leading scientists on this issue. And with all of this external support that we’re seeing, it’s clear that the people are catching on. The problem is, I would say, that we have seen very little movement overall.
We had a meeting with CMS the other day, and I would say that the meeting did not evoke a sense of urgency at the end. It ended as many meetings do with, okay, well, that’s great, great to talk to you. And I think FDA has shown little willingness or interest to move in. And I can’t tell – I think what’s happening, I want to get this out of FDA’s domain altogether. They are not an entity that is charged even with evaluating public health tools. They’re charged with evaluating diagnostic tools. In some ways I’ve been a little bit unfair to the FDA because I’m asking them to change their view. It’s like asking a physician to treat patients with the mindset of the public health alone. And this is a constant tension that exists in medicine and public health, they’re not always completely in line.
So I think where we need to start is, frankly, it needs to be something at the CMS level where CMS decides that there’s a different pathway, that these can be not under CMS and CLIA regulations, and then they don’t have to go to FDA. The other option, which I think really needs to happen, is Jared Kushner and the White House administration are aware of these, and I think that it needs to be, potentially, a process that’s promoted at that level to really change the course of this epidemic. But otherwise, I think we’re just kind of stuck in this limbo where nobody really feels that this is their problem, that these tests fall under their jurisdiction. And that’s what’s just infuriating.
MODERATOR: Do you have any follow up questions?
Q: Yes, one more. How much of the unwillingness to to budge do you think might come from what we saw with antibody tests a few months ago when they were sort of flooded with the market and there were accuracy concerns? Do you think that sort of plays into it at all or sort of how does that relate to this situation?
MICHAEL MINA: Yeah, I think it’s unfortunate. I think the FDA initially was so stringent that essentially we had no testing for months and it was a disaster. It remains a disaster, relatively speaking. But as a true disaster in February, March in terms of no testing, essentially. So then they kind of swung the pendulum and approved, and allowed all of these horrible tests to come through and the antibody space that they were just giving wrong results and throwing up public health metrics. And the difference there is that also, because they were antibody tests, and antibody tests are extraordinarily important, we should be scaling them up as well. But they are not tasks that are necessarily going to be actively used to suppress an ongoing outbreak. There are good tests to use for public health monitoring, forecasts for the virus, MYCO, things like that. So I think when FDA released those somewhat in response to the early blunders, they said, OK, we’re going to let these things go quickly. And that was terrible. I don’t need to go into detail, but I think what’s happening now is, as you mentioned, a response in large part to those continued blunders where now they’re back and they’re saying over the last time we allowed rapid tests to go forward, they were terrible and it was a disaster. So now what we’re saying is that there’s a different utility of these. They wouldn’t be as much of a disaster. We would still hold them to high standards for public health use. But I do think that there is some memory of that experience is certainly lingering. And I can’t imagine it’s not affecting their decision making process.
Q: Thank you. That was helpful.
MODERATOR: Next question.
Q: Hi, thanks Dr. Mina for doing this call. I wonder if you could just speak about what you think is the utility of using antigen testing inside of Long-Term Care Facilities. And on the flip side, any shortcomings or even drawbacks of using those kinds of tests in that setting?
MICHAEL MINA: Yeah, I think that if we can use them every day, I think that they are an incredible boon. And the important thing to recognize here is I’m not saying we should get rid of anything else that’s already happening. I’m just saying we have another very strong layer of detection to know who is or is not a risk of bringing a virus into a place like a nursing home, into a place like a school. And in so doing, dropping potential community level transmission at the same time. So I think that if we can get every single staff member in a nursing home to be using one of these every day before they enter, it will at least do an immense job at cutting out potential avenues and sources of new exposures and entries of this virus into these facilities.
A lot of people get confused and they say, well, if you’re gonna do that, how can you make sure that everyone’s going to be perfect? It’s not going to work perfect, but we have to look at what we are doing now. I’m not saying to change anything else that we’re doing currently, but we have to look at what is happening today, which is nothing. We essentially have no public health surveillance that’s actually useful to stop transmission chains. My best estimate on what the sensitivity of our current surveillance system of testing, which is costing millions of dollars and is just clogging up diagnostic testing, we probably catch in this country less than 3 percent of people in time to make a difference in their transmission patterns. Less than 3 percent is our current sensitivity. So anything at this point is going to be hugely beneficial. I’m suggesting that we just change it. I’m not suggesting that these will be 100 percent, but compared to 3 percent, and I could talk about the math if anyone’s interested, because it’s not hyperbole, but less than 3 percent, if we can bring that up to 50 percent, that would be a huge gain for us. And that alone could serve to stop the outbreaks that are happening in Texas and Florida, California. But at the moment, a three percent sensitivity with PCR to catch people when they’re infectious is not going to cut it for any purpose.
MODERATOR: Do you have a follow up?
Q: Actually let me follow up with one thing. Do you see these as potentially, per the point you were making about stopping transmission chains, do you think these tests would be valuable to help do that? Or is it more valuable in another purpose?
MICHAEL MINA: No, I think that these would be extremely valuable to stop transmission chains. These rapid tests will detect people when they’re infectious on the day they turn infectious. So it will cut out and that person will not go and walk around for five days as an infected person. Even if it doesn’t capture everyone, it will do a whole lot more than the current 3 percent. So I don’t see any other option. And with all the criticism that this gets, and it also gets a lot of support and more support than it’s getting criticism, I haven’t seen a better option put out there, frankly. I don’t see an avenue where these will not help to stop transmission chains. And I don’t see another option on the table for us.
MODERATOR: Are you all set?
Q: Yeah, I’m good. Thank you.
MODERATOR: Next question.
Q: Hi. Thanks so much for doing this. I just wanted you to talk a little bit, if you would, about the Ohio governor and what happened with his testing positive and the negative. Just in the context of the flaws in these tests, if you will?
MICHAEL MINA: Sure. Laboratory-based diagnostics, as well as these rapid diagnostics, are never 100 percent. Unfortunately, the fact that this is making headlines just shows how sensationalized this has all been. And this is a very common effect of testing people, especially when we get into testing people a lot, when they have low what we call pretest probability of being infected. You run into the issue of having potential false positives. This is the same with HIV. This is not a big problem, though, overall. And I’ll get to that. But with HIV right now, when you have a low prevalence of HIV, meaning that in general screening pregnant women, we screen them for HIV. Many of them have a very low pretests probability for being infected. And as many as half in a place like Massachusetts, for example, of the positive screens that we get are false positives. But there’s a very simple solution. And I hope that nobody on here decides to put that as as the title of their story. The Harvard professor says, I half are false positive. That’s not what I’m getting at here. What I’m getting at is this is common and we have a very simple solution, and that’s that we have an immediate reflex to a confirmatory test. We have what we call two different types of tests that are orthogonal. And what I mean by that is you have one test that looks for one type of material and a difference, for example, one piece of the virus, and another test that looks for a different piece of the virus and that can be used as confirmatory. We do this all the time in laboratory diagnostics. It is a very common theme.
What happened with the governor is the system, frankly, worked as it should have. It would have been quicker and wouldn’t have been any issue if they orthogonal test, the confirmatory test, was available right then and there. But it wasn’t in his case. And it’s not because we don’t have wide scale testing available every day for everyone at this point in time. But what happened was exactly what we would expect to happen, he got a false positive. And sure, it threw off some of his plans. And because he’s a governor going to visit Trump, it made the news. But at the end of the day, it just caused him a few hours of annoyance, and he got his confirmatory tests and it came back negative. That’s a whole lot better than if we weren’t testing him at all and he was positive and he went and infected a lot of people.
So this is a common theme and hat my solution for these rapid tests would be is that if the feds or other people are producing, with every box of 50 tests that somebody buys for 40 or 50 bucks, you get a test that’s going to last you two months or you get a box of tests that will last for two months. And with every set of 50, you have five additional tests that are orthogonal, that are also a dollar apiece to make. And so there are very simple solutions to these issues that just aren’t being discussed because frankly, most people who are discussing these problems are not laboratory medicine doctors who do this. And I would say, this isn’t a knock on anyone on this call, but I’ll just be very frank. It’s the media, it’s scientists, it’s everyone have generally allowed everyone to have similar levels of voices. And so we have all of these people who are complaining about things who don’t normally deal with infectious disease diagnostics.
But if you talk to infectious disease diagnostic physicians, they’ll say this is a common problem, not to worry. In the same way that immunology, if you really talk to good immunologists who know what they’re talking about, they’ll say waning antibodies aren’t unexpected. And so I just think the fact that this made headlines yesterday is beyond frustrating to me, because the system ended up working as it should, and instead what it did was it is a knock again against rapid tests that could be lifesaving. But at the end of the day, we saw that it worked well. And OK, so the governor didn’t fly to see Trump. So be it. The alternative of doing no testing on him, if the rapid test wasn’t available and he was infected, could have been much worse. I think we always have to keep that in mind.
MODERATOR: Do you have a follow up?
Q: That’s it. Thanks so much.
MICHAEL MINA: OK, sorry about my outburst there.
MODERATOR: Next question.
Q: Yes. Thank you. This has been fascinating. Michael, we talked about the antigen tests that are being shipped out to nursing homes by CMS, which can get results on site in 15 minutes. Is your sense that that alone won’t get us there, or is it a similar problem with respect to the technology? Then I have a quick follow up question.
MICHAEL MINA: Yes. So these antigen tests that are being rolled out won’t be enough to test everyone every day, for example. There’s been a lot of news and a lot of discussion about these antigen tests being introduced and including the six governor pact a couple days ago led by Maryland, to purchase three million tests, collectively, five hundred thousand per state. These are still fairly expensive, and still, each test needs to go through a machine, and many of these machines are hundreds of thousands of dollars. So the tests that are being approved in use today are not quite the same tests that I’m referring to.
I put them in two different camps. I put these sort of rapid tests into two bins. I would say the tests that are being deployed now, are like the Nespresso machine models. These are tests that require instrumentation, and they’re kind of like deluxe Nespresso machines. There will be a big start up cost to get it going, then each individual test will be expensive. And so, you know, relative to what I really want are the instant coffee versions where a cup of coffee using instant coffee is pennies versus a dollar, and just scale those appropriately. I wanted one dollar thing versus a 20 dollar thing for a test. And the other bit is that the antigen tests that are being distributed to all the nursing homes, because they’re more highly manufactured, they will have a difficult time getting the scale to where it really needs to be to make an impact on a population level. For the nursing homes that can get them and get enough tests in so that they can test all the staff members before they come in each day, it will be great. It will be game changing for that nursing home. So I am not at all knocking that effort. I think it is what we need to be doing right now until we get this sort of instant coffee version or even in addition to when we get this instant coffee version, cheap point of care at home test for everyone. We need to be trying as much as we can to focus the testing where it’s going to be most effective at saving people’s lives. And that would be nursing homes in this case.
And these are very good solutions. They will go a long way to stopping transmission, if a nursing home is is asking every staff member to test themselves, even if it’s not every day, it’s every other day, then it’s like wearing seat belts. If you wear your seat belt most of the time, then most of the time, you’ll have some added protection. But, you know, not wearing it one day doesn’t mean that all the days you do wear it don’t count. And it’s kind of similar here that this is a risk mitigation strategy. This is an important one that you’re asking about.
Q: All right. Thank you. And then just a quick follow up question. The instant coffee test that you’re describing, which I love, what are they testing for specifically? And do you feel comfortable naming or where would we go to find out what companies are currently working on this?
MICHAEL MINA: Yeah. So they’re very similar to the tests that are already out there. The difference is, the tests that are out there, like Quidel and NBD, they have the reader. So they have the instrument, the espresso machine, if you will. And that allows it to have a better detection signal because, actually, you’re not reading it with the naked eye. You have a little instrument that’s reading it. So the other effort is to make them either get the instrument so that it’s twenty dollars and every household can have an instrument. And there are companies that are trying to. I think twenty dollars, it won’t get there and it will still be limited. You can’t make 100 hundred million of those instruments in a short amount of time to get one in each household. So the companies that are making sort of the instant coffee version are companies like Sherlock Biosciences. They’re developing one, and these are just these are Boston based companies. E25Bio is building one, and they are actually in clinical trials now. So they seem to be pushing forward. But again, they’re a three person company. And so we need to really either do something to get it out of their hands or combine them with NIH or something.
Then the other one is 3M. 3M is actually a major company, as you know, and they are working on a test with Hadley Sikes at M.I.T. And I know a little about that. But my expectation, knowing how this works and knowing the quality that 3M and the scale and scope that 3M brings to the table is this might be a game changing solution. It won’t fit all the boxes that the FDA wants for a diagnostic test unfortunately. So 3M might come out with a product that will be game changing that they were able to use in the United States. The product could exist right now. And a lot of people are wasting time trying to figure out how in the heck are they going to get instant coffee to be as good as an espresso while keeping the price reasonable for every American use every day. And while still trying to meet all the boxes and it’s just they’re different things. And so until the regulatory landscape changes, these companies have no reason to try to bring a product to market if it’s not going to fulfill what the FDA is asking for. So a lot of them are just kind of sitting on it. They’re trying to spend more time and more money to better and better optimize the tests, which might take months so that they can meet the FDA approval. And my fear is that what will come out of it at the end of those months is a test that does meet FDA approval, but that’s too expensive and too complicated to scale and to use for everyone. So in some ways, the current landscape is bottleneck in these companies that could have a cheap test today into producing a more expensive espresso machine when, you know, because they can’t actually legally use the instant coffee. So those are three companies. And again, I would just push to say that this shouldn’t be being driven by any one of these three companies, that they either all need to be working together with the NIH or with the federal government to create a federal response to produce these.
And I just want to be very clear in case, because as I’ve become more vocal about this, there are a lot of people think that because I’m at Harvard, I have ties to any these companies. I have no financial ties or any other connection to any of these companies. I’m truly just basing this on science.
MODERATOR: Next question.
Q: Thanks so much for taking my question. It kind of goes back to the previous one with the federal response and regulations, and it might actually be a clarification of something you were just talking about here. I saw the FDA recently posted a new template for these companies to apply for EUAs, for these rapid at home tests. Does this at all loosen any of the red tape you mentioned or not really, because they’re still being treated as a diagnostic thing? Just trying to make sense of what this FDA announcement means for the general population and our ability to, you know, go to CVS and buy a test.
MICHAEL MINA: Yeah. So I was initially excited and then taken aback by it. Essentially, it was one step forward in that the FDA came out and said, we are providing you with a template, and we’ve heard your cries. We want to open a pathway to getting rapid at home over the counter tests to become available. So that was the step forward, that they actually put the idea out there, or they put the template out there to suggest how it might work. When you then go in and read what they have in the template in terms of the metrics they will be looking for, pretty much what they have done is taken five steps backwards towards the use of these as a public health tool. And that’s because there’s two major criteria. They are still asking for it to be 90 percent as sensitive as PCR based diagnostics, which I first said when we started this conversation, we have to change this message. We have to get the point across even to scientists. And the FDA and the CDC aren’t completely aware of this issue, which is that we can’t expect an antigen test to meet that criteria because most PCR positive results in much of this country are representing RNA positive samples with no live virus in them anymore. So the requirement of 90 percent sensitivity against PCR doesn’t doesn’t add up.
There needs to be a different metric. We need to say 90 percent sensitivity to detect people in their transmissible. What I would like to do, though, is get out of all of that and say this is a public health tool, and heck, for public health, if it means we could even just catch 50 percent of people that are transmissible, we would immediately drop incidents across the whole population. And that makes everyone safer. So the requirement for this 90 percent sensitivity was one knock on it. The other big one was they said, we expect that any test that is used by anyone, that the test will come with some mechanism to report to the departments of public health, the result of that test, negative or positive. So imagine imagine how much of a pregnancy test would cost if it had to be connected to the Department of Health. You know, it’d have to come with a Wi-Fi signal and all that stuff and would have to be in an espresso machine model. So you can’t have a paper strip test and still have the expectation that there’s going to be some direct way for it to connect to the Department of Health. It’s essentially asking these diagnostic companies, which are already small and overstretched, to become software companies as well. So maybe some third parties can get involved and collaborate, but it adds months to the effort of getting these things out and we need them today. It’s a tool that can stop infections today. It would be like saying we can’t use the vaccines unless the vaccines had a little code on them that could ensure that we know exactly who is getting vaccinated and when. Maybe that will happen because we’ll have health care administrators or health care personnel administering the vaccine. So it’s a little different. But we wouldn’t hold up the vaccine program because of that. And we shouldn’t be holding up these tests because of them.
Q: And then the second question here. I don’t mean to ask you to speculate, but I think you’ve been calling for these rapid at home tests since I mean, some of these calls back in early April. Are we any closer? Is this one step closer? Do you anticipate we’ll be seeing them anytime soon? Or is the vaccine going to be before these are even available?
MICHAEL MINA: I am hopeful that the groundswell of support that we’ve seen from people who have federal voices in the Senate. And then we’re getting conversations with the NIH and the FDA and CMS. Actually not the FDA, unfortunately, but CMS and the White House and Congress. We are making some headway and having these conversations. And I think it just takes explanation. I would appeal to the media who are on this, call, I take some responsibility for this because one of the first ways that I started talking about this was calling them low sensitivity. I even called them crappy tests and that unfortunately got picked up. But I’ve decided there needs to be a different way to call these. And this isn’t just me changing my mind, you know, these are not necessarily low sensitivity. They’re low analytical sensitivity compared to PCR, RNA, but these are high sensitivity. You could call them more accurate tests for knowing when somebody is infectious. And I would just say, you know, it doesn’t make us good headlines as saying, “Harvard professor calls for crappy tests to save the world.” But it does change the narrative. And I think that if we can start calling these high sensitivity, high accuracy to detect transmissible people or to detect highly transmissible people tests, that’s something that politicians can get behind and really clutch.
And you all have the the loudest voices in the country, in the world, you know, short of a few individuals. And if that type of mindset and labeling of these, if that message can start getting across that these are public health tools, they are accurate tools and powerful tools to detect people who are transmitting and they will break transmission chains. And we forget about how well they work as diagnostic purposes because they are different things. Then all of a sudden they become very powerful and the public message really can change around them.
Q: Thank you so much.
MICHAEL MINA: Absolutely. I can take one more question.
MODERATOR: Thank you. Final question.
Q: Thanks so much. Just a quick follow up on all this. So are any other countries moving forward with this and finding success?
MICHAEL MINA: So the idea is fairly new in terms of using these daily for everyone as a public health metric. But in the last couple of months, yes, I think Senegal is starting to trial them. I’ve been personally talking with the heads of numerous countries in different parts of the world to essentially bring the companies together that can produce them, to have them start to be rolled out in other countries. And I would love for them to be rolled out in the United States. They’re being developed and invented in the United States. The reason that other countries aren’t quite there yet is there is some reliance in some ways on the companies that are producing them in the U.S. to the companies that are producing them in the U.S., don’t currently have a huge incentive to go to market with them at the moment just because they’re usually looking at the U.S. market. As things are progressing, there is a lot of discussion at this point about how to roll these out in other countries. And there’s been a tremendous interest from the heads of states of other countries that I’ve spoken with as high as they go. And so I do believe that we should expect to see some of these companies start to be manufacturing them to be exported pretty soon.
[01:00:54] And other countries, I was just talking to somebody on the other side of the world, I won’t say the country, but now they’re just laughing at how complicated the U.S. system has gotten that we can’t find our way around this problem. And again, it’s because we’ve undervalued public health for so long that we truly don’t have a language even at the Fed or at the regulatory level to know where are these tools for public health. There is no regulatory body surrounding public health, biological tools like this. And and so other countries are kind of, you know, wondering what the heck we’re doing over here and not getting our act together to use these things. And they’re saying, OK, well, we’ll take them. And I’m not involved day to day with it, but I’m putting them all in touch with the companies to hopefully get them manufactured and sent over.
Q: A quick follow up. I’m here in Minnesota at 3M is here, so we’ve written about what they’re doing, but are there particular countries that have signaled a willingness to kind of put some dollars towards it towards like a government backed program?
MICHAEL MINA: Oh, yeah. I don’t feel at liberty to say what they are at the moment. But, yes, I can truthfully say that there are heads of states that are very, very interested. And I’m on the phone with them every couple of days right now to help figure out what the plan will be, what kind of pilot it looks like if they were allowed a few million of these tests and a community is to watch community transmission plummet. So we’ve been discussing how to get it going. And I’m hopeful, actually, that some of the countries that have the money to really pay the full price for them versus some very poor countries, which might not have the ability to pay millions of dollars for millions of tests, if they do go ahead and purchase them, that it will actually infuse some cash into these companies. And maybe the companies can go from 3 people to 30 people or something and really start to make headway. So, yes, the short answer is there are major countries that are interested.
MODERATOR: OK. Dr. Mina, I think that’s our last question. Do you have any final thoughts you’d like to share with us?
MICHAEL MINA: No, I don’t. I hope that the message gets across. I think, though, the last comment is really just these are our hope. We don’t have a vaccine tomorrow. We don’t have anything but shutting down the economy tomorrow and keeping schools closed. This can work. And I just hope that it gets across to the people who it needs to get across to. And the media’s a good conduit to do that. This is a tool that, tomorrow, could start to go into production and within a few weeks time could start to make to change the whole course of outbreaks in major cities in America. And in so doing, make all of the United States safer. We’re in Massachusetts. We have fairly low incidence, but we can’t realistically open up schools and colleges the way we would want to because there are cases burning and outbreaks burning across the country where a connected country. And we need to figure out how to get these outbreaks under control. And this is a solution. We have the power to actually turn it into the solution. Vaccines, we can’t speed up very much. Therapeutics, we can’t speed up very much. This is something we could actually do at warp speed and make it happen. And I want to really push that message.
This concludes the August 7th press conference.