NIH Wants to Rapidly Accelerate Diagnostic Testing for Coronavirus

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The National Institutes of Health wasted no time and putting pandemic stimulus money to use. It launched RADx, a program to enlist industry and academia in a biomedical engineering approach to the pandemic. It stands for rapid acceleration of diagnostics. The program officer of the National Institute of Biomedical Imaging and Bioengineering, Michael Wolfson, joined Federal Drive with Tom Temin to share the details.

Interview transcript:

Tom Temin: Dr. Wolfson, good to have you on.

Michael Wolfson:  Hi, Tom, thanks to be here.

Tom Temin: So tell us what’s going on, what is RADx all about, first of all?

Michael Wolfson: Well, ultimately, this is a challenge with how do we get people back into the workforce out of their homes and into normalcy? And the big problem here is not just the vaccines – it’s how do we know who has the virus and whether they’re transmissive at the moment, and whether they’re safe to go out and public? We’ve been doing diagnostic testing since the very beginning, but it hasn’t scaled up as fast as we need it. We’re currently at about 400,000 tests per day and we really need to be about 6 million.

Tom Temin: Got it. And so what are you seeking from whom in the RADx program?

Michael Wolfson: Well, we are seeking ideas at an early stage, at a late stage – we’re trying to cover all our bases. We want to go from what we don’t have to what we need. And it’s not just a matter of building more of what’s out there right now – the commercial technologies – because those are lab-based equipments. We want to get stuff into people’s homes into nursery schools, into nursing homes.

Tom Temin: So maybe someday a little peripheral on your smartphone that you could go like this. And it would tell – people can’t see this, I just touched my forehead with my smartphone – but that would maybe transmit this type of information electronically?

Michael Wolfson:  Actually, something a little closer to a pregnancy test would be the ideal, where you take a little bit of spit and wipe it onto a small device. They hand-held it and it changes color, it’s a piece of paper. That’s what we’d love to see.

Tom Temin: So this presupposes that there are ideas in incubation all over the country now that you might not be aware of, and you’re trying to attract them to NIH through this RADx program?

Michael Wolfson: Absolutely. And we’ve had a overwhelming success in that outreach. Within one week, we had about 100 proposals in our system. And now it’s been about a month later and we have 400 full proposals. We’re reviewing them. We’ve done a deep dive – a seven-day, deep intensive evaluation of these proposals, and we’re moving forward with 11 of them for now.

Tom Temin: Got it. And how does this work as a program? Are you looking for grants to give out? Is it contracting? Is it a challenge program, a prize challenge money? How does it all work from a program standpoint?

Michael Wolfson: Oh, we’re using all the tools in the toolbox, frankly, because normal NIH process it takes about a year from the time we received grant application to the time it gets funded. This is our deep, rigorous peer review process. Here what we’re doing is we’re doing initially small supplements to some of our center grants. Ultimately, if those are successful, if they de-risk then we’ll issue some letter contracts.

Tom Temin: Got it? So right now you’ve got 400 things to look at. And can you just give us a broad sense of what types of things people are proposing? Are there certain buckets that they fall in that are common?

Michael Wolfson: Yeah, absolutely. There are a whole bunch of different buckets, bit of things are falling into. I think the big ones are if we break it out, we’re looking at blood, sputum, saliva, nasal swabs, fecal – everything, every possible kind of fluid that we could possibly get access to –

Tom Temin: If it comes out somewhere, then they’re looking at it.

Michael Wolfson: Yeah, absolutely. And we have been reaching out. And our proposals have come in from a wide variety of sources, I’d say about half of them are small businesses, about a quarter from academics and the rest from start-ups that have been in business for less than a year – mid-size and large companies.

Tom Temin: Now every time I look at a television screen, and they have a story about this, there’s a picture of what looks like a soccer ball covered with mushrooms, and that’s their depiction of the COVID virus germ, the virus. So we know what it looks like, I guess, it’s some sort of visualization of what this molecule looks like or whatever a virus is, a bunch of molecules. And so what is the essential difficulty in understanding when it is in someone? What is the core problem here that seems so difficult to solve?

Michael Wolfson: Well the core problem is that they are very, very small. And there’s all sorts of other material in her body. How do you detect something that is less than a millionth the size of your entire body, if it’s only at a fraction of the percentage of your body? So if you only have it in your nasal passages, if you take a blood sample – may not have turned up there yet. Part of the challenge is are you sampling the right place? Part of the challenge is amplify that really tiny signal. Can you detect 50 virus particles and amplify that to something that you can see in your hand?

Tom Temin: Got it because I imagine, and tell me I’m not a physician but, doesn’t the body normally have lots of viri that are just there and benign, just like it has tons of bacteria that are there for some purpose that aren’t harmful?

Michael Wolfson: Absolutely. And there are four circulating coronavirus viruses out there that are common in humans. They cause the common cold, some of the causes of common cold.

Tom Temin: Got it. We’re speaking with Dr. Michael Wolfson. He’s a program officer at the National Institute of Biomedical Imaging and Bioengineering and the NIBIB – your institute – what do you do there that this program falls under your purview?

Michael Wolfson: Well, so my day job is to fund research project grants, things that are more of the systems engineering direction, because most of what comes into NIH is basic research to understand a biology, understand a disease, understand its progression, understand its impact on people. But we have our small but mighty Institute – NIBIB – to take what is known and turn it into therapies and cures. And my job is to do that.

Tom Temin: Got it. And so let me ask a bigger question here, given the size and scope of this problem, and it’s something we really haven’t seen, you could argue in a century in the United States. When I was a kid, they used to say, we’ve put a man on the moon, why can’t we solve the common cold? I know that people still say that, but just in this past couple of weeks, we have returned to being able to launch people at least into near Earth orbit, and maybe to the moon. Could the work being done on this germ which you say is of a class that causes, also causes the common cold? Could we be on the verge for cure to the common cold from all this?

Michael Wolfson: That’s a, that’s a challenge that – it’s a challenge that we had NIH would like to tackle. It’s a big challenge, though, because part of the challenge is that we have to deal with evolution. These bacteria and viruses that cause the common cold that cause disease evolve, they mutate. And every time our immune system reacts, they try to get out of that. What’s different about this particular coronavirus is that it seems to evolve slowly. So we should be able to eventually come up with a good vaccine that targets every aspect of it.

Tom Temin: And getting back to the question you’re trying to solve, which is detecting it basically, as it morphs. I would imagine that part of the solution to detecting has to be a agility in the algorithms used to detect such that as it evolves, whatever it is you’re using to detect can keep up with it.

Michael Wolfson: Absolutely. You got that right. And one of the reasons that we’re primarily focusing not on detecting the antibodies, which is the body’s immune reaction to it, but the virus itself, because if we detect the virus itself, then we can adapt our diagnostic tests to what exactly is happening. Most of what we’re going to be funding is probably just ripping apart the DNA of the virus, and looking at that code.

Tom Temin: And just getting to the issue of being a federal scientist and working in the premier research organization, in some sense in medicine in the federal government, and many in the nation, in a sense – is this the biggest thing you’ve ever experienced? And what is the feeling in NIH right now, even though you’re not all together on the campus? Is there the sense that this is something that is just, way outweighs what we’ve done before?

Michael Wolfson: I think it doesn’t outweigh the things we’ve done before. What it does is it’s the immediacy of “this is one moment in time.” It has not happened in a century, where we are called upon to deal with a global crisis.

Tom Temin: Because smoking, cancer, opioid addiction – these are all issues NIH is dealing with somewhere or other. And they affect millions of people in terrible ways. But it doesn’t have the quality of randomness, I guess, maybe that the COVID has?

Michael Wolfson: Those things that you just mentioned – cancer, addiction – those did not happen overnight. This happened effectively overnight, which is why it has sprung to prominence. Why we haven’t been able to drop everything. We’re still doing our day jobs on top of trying to fight this pandemic. I guess the sense at NIH is that we are called to task here. We are here to do a mission and boy are we trying to do our best to resolve that.

Tom Temin: Dr. Michael Wolfson is program officer at the National Institute of Biomedical Imaging and Bioengineering, part of the NIH. Thanks so much for joining me.

Michael Wolfson: Well, thank you for having me, Tom.

Tom Temin: We’ll post this interview along with a link to more information at Hear the Federal Drive on demand and on your device. Subscribe at Apple Podcasts or Podcastone.

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