Testing remains critical first-line of COVID-19 defense

Products and Innovation|Jan.12, 2021

The coronavirus the world has come to know originated in 2019, dominated in 2020 and won’t be vaccinated out of the human condition by the time 2021 comes to a close.

So even as more people receive inoculations against the virus from here on, COVID testing of every sort and on every platform — from molecular to antigen to antibody and from labs to immediate care centers and, yes, your home — will continue to fill an important and crucial role in the fight against the pandemic.

That is the state of things.

And this is the COVID-19 State of the Union, an interview with Andrea Wainer, Executive Vice President, Rapid and Molecular Diagnostics at Abbott, conducted by Michelle Fay Cortez, science and technology reporter for Bloomberg. The interview was among the keynote addresses in the health track of CES, the Consumer Electronics Show.

CES — normally a gathering of hundreds of thousands from around the globe to the arid Las Vegas desert — is as virtual as you’d expect during a pandemic. The interview, presented here in-full with only minor edits for clarity, was conducted via Teams and broadcast Tuesday morning.

What does Wainer see as the state of COVID testing heading into 2021?

"Testing is a critical first-line of defense," she told Cortez. "It needs to be used in context with other hygiene practices of wearing your mask and washing your hands and by no means does this replace that. It comes together along with vaccinations. So, the more you can test, the more you can catch the virus. It’s just simple math. Because at any one point in time, anyone can become infected."

From Abbott’s first molecular COVID tests — created and brought to market in 30 days, a miniscule fraction of the time normally required — to the ways in which the company is ramping up capacity to meet the world’s demands for tests, which number in the hundreds of millions with no end in growth in sight, Wainer and Cortez cover a lot of COVID ground quickly. Enjoy.

MC: Thank you so much for joining us.

AW: Thank you for having me.

MC: We're going to talk first about how you guys even heard about the virus. We know that Abbott actually has a team of Virus Hunters. So on the very front foot, you guys knew this was coming at the end of December (2019). It’s crazy to think that was only a just a little bit over a year ago. But really, when the rubber hit the road, that was in February at Abbott. Tell me what you guys were doing at that time.

AW: Yes, exactly Michelle. I can’t believe it’s been about a year that we’ve been in this intense focus of working on COVID tests.

And you’re right, it was about a year ago that we were tracking the virus, starting to develop a molecular test, as we always do at the beginning.

But it was in that mid-February timeframe when we were having our update with our R&D leaders, our business leaders, that we knew at this point in our discussion that things were different. This virus was different. The outbreak was spreading across the globe. And really, who was loud were our customers. Our customers were starting to call, asking us to bring tests. And we knew they were counting on us, the world was counting on us. Because with the scale that was going to be needed, the big, large diagnostic players were going to need to play a role.

So it was at that point in time we all agreed: We have 30 days to get these tests to market.

And 30 days not because we thought we could do it. But 30 days because we knew the world needed us to do it.

Which then the discussion led to: What is it going to take? And it’s going to be different. That's when we started talking to our scientists: Tell us day-by-day, tell us hour-by-hour, what it's going to take and where we, as the leadership, can remove the barriers. And what it came down to was not big dollars. It was, How do we move materials for them? How do we transport to get them the different instrumentations so they can do their experimentation? And how do we leverage the current platforms and tests we have to bring products to market when we got that authorization.

That's exactly what we did. And it was thinking differently. It was that meeting in mid-February that we all aligned, held hands and pulled everybody off all of our other projects to make it happen in 30 days.

MC: That is amazing that you were able to do that in just 30 days. Tell me, how long does it normally take to get a new molecular test or an antibody test out there?

AW: Well, when you’re talking about a new test and new virus, it can take years. Because when there’s a new virus, there’s a lot we don’t know about it. It’s first understanding how you detect the virus, what’s clinically relevant, what we’re looking for and making sure those tests have clinical utility. And then, of course, the time it takes to develop manufacturing. So it typically takes years, and not weeks, which we had. Which was basically understanding: What is the most important thing we need to do to keep public health in mind and balance what type of tests we need to bring to market so we can add value immediately?

MC: So, tell me, what were the three tests that you guys did bring to market in just four weeks?

AW: We started with our molecular test. It was the first test we brought to market. It was our m2000, which is our high throughput molecular lab-based instrumentation. This is typically where we put a lot of our virus detection tests. That was the first product we brought to market. It was actually about three weeks’ time from that February meeting that that product hit the market and we had a million tests out in that first week.

And then the second test we brought to market was our rapid point-of-care molecular instrument that was put on ID NOW. And that was the test that really got a lot of attention because it was the first point-of-care molecular test with a positive result in five minutes and a negative result within 13 minutes, bringing testing to physicians’ offices, ER centers and any urgent care environment. And that was really also important that we brought a million tests to market within the first week.

And shortly after that, the third molecular test we brought was on our Alinity m new platform, which is a couple months after that.

MC: You already talked about that there were more than a million tests for these that were ready right from the get-go. Can you put that into a little bit of perspective for us: How many tests do you guys do in general over the course of a year or when we’re not in a pandemic? And how many tests are you imagining you’re going to be doing in 2021?

AW: Maybe I’ll put 2020 into perspective compared to an average 2019.

So in 2020, we ramped up 11 tests around the globe within just 10 months. In 2020 alone, we distributed over 300 million COVID tests.

Now let’s compare that 2019 during an average flu season where we had flu tests. In 2020, we distributed about 15 times the number of COVID tests that we did in an average flu season in 2019.

And we expect ’21 to be even higher.

You’ve seen the year kick off, you see the numbers. We see that we’re going to expect even more testing as we’re trying to address the pandemic and get people back to work and back to school. We see those numbers rising.

MC: The BinaxNOW story is just astonishing. That, of course, is the test that works like a pregnancy test that you can just get a result, it’s disposable. It’s just been authorized where you can actually get it at home, sent to your home, test at home, get the result at home, in minutes. Tell us about that technology. And one of the most critical things about that piece that is astonishing to me is the idea of what you guys did in advance to make sure you were going to be able to meet the demand for this test. So walk us through that part.

AW: OK. It was about in April that we started to think about: How do we get people back to school and back to work, starting about the fall? And that’s when we decided that we were going to bring both antigen tests to market in the U.S. as well as outside the U.S. and began our efforts in developing those tests as well as preparing to manufacture. Because rapid antigen tests can be done much more affordably and much more at scale. And so that’s where we knew that we had to bring large number of tests to allow for frequent tests across these large populations.

It was before we even developed our BinaxNOW test that we started to build two manufacturing facilities, two new state-of-the-art manufacturing facilities. Hundreds of millions of dollars before we even knew we had a test because that was what it was going to take to make sure when we launch we can get quickly to that ramp target we had of 50 million tests a month. And we did the same with our Panbio test outside the of the U.S., making sure that we leveraged our current manufacturing capacity.

So we worked through the summer months on the manufacturing scale up in making sure we brought that test to market. And indeed, we brought BinaxNOW to market in August.

And shortly after that, we were able to ramp up to that 50 million number of tests because of getting ahead of time in manufacturing scale up and working with all of our suppliers that were required to build at that type of capacity.

And our whole vision with the rapid antigen test is again about access, it’s about affordability, it’s about being able to get testing into alternative channels where equipment isn’t needed to really slow the transmission of the virus. These are tests that are working fast in that first seven days of post-symptom onset when the infection has high viral loads and you’re most at risk of transmitting the virus. So, again, we wanted to get this out to as many people as we can because it’s that first line of defense in slowing the transmission.

But you brought up the home test. The next step was to say how do we also again continue to expand out access by bringing it into the home required us to look again to an alternative solution which was to now partner with our telehealth partner eMed to be able to send a test to a person’s home and then to be able to have them work with our telehealth partner to have them bring and guide an individual to be able to take a test over a computer screen like we’re doing right now and to be able to guide them to run the test and interpret the test and then get their result via our complementary mobile app NAVICA to be able to get, if they’re negative, a digital health pass right there and then. And if they’re positive, to be informed to talk to their healthcare provider. So again, this is some of what we did to bring that to market in such a short period of time.

MC: So Andrea, what is the demand looking like for these tests now? Are you able to meet what the demand is and are people embracing this at-home testing.

AW: So the demand continues to grow. What we see at the beginning of the year is that as the pandemic is continuing to surge and people are feeling more of an urgency to get back to normalcy, to get back to work and get back to school, we’re continuing to increase our capacity and continuing to look at what we can build. So, for our at-home testing just in the first quarter alone, we’re going to be bringing 30 million tests to the market and ramp up 90 million of those at-home tests in the second quarter. And yes, we see that the demand is going to surpass the supply and so we’re going to continue to look at how we can expand in manufacturing capacity to continue to meet what the world is needing from us.

MC: Of course, the question that everybody is really hanging on here is when are we going to be able to get back to school, to work in person, to social events, to entertainment, concerts, plays, that type of thing? To what extent is testing going to help us do that? And Andrea, tell me, what will that look like? Walk me through a morning of going into a school or going into a workplace or going into a concert.

AW: Absolutely. Testing is a critical first-line of defense. It needs to be used in context with other hygiene practices of wearing your mask and washing your hands and by no means does this replace that. It comes together along with vaccinations. So, the more you can test, the more you can catch the virus. It’s just simple math. Because at any one point in time, anyone can become infected.

So the frequency of testing is very important to be able to catch someone when their infectious and can pass on the virus. So the protocols in terms of how best to do that? The CDC has put out guidelines, the Rockefeller Foundation has guidelines.

But what we could see is its best used for example in any environment, depending on what your protocol is, to be able to test and be able to provide on the spot people with that negative entry card, that digital pass that shows “I’ve been tested” and now I can show that pass before I enter whatever environment, like a boarding pass or a NAVICA complementary mobile app can be used like a boarding pass.

So I go and I get my test and then I can demonstrate that I have been tested and I’m safe to enter along with my other entry passes. The more that a school or a workplace, the more frequent that they can do that testing, the better off you’re going to be in slowing the transmission of the virus and catching those who can put your environment at risk.

MC: To what extent is testing going to remain important as we start getting higher levels of vaccination across the United States and the rest of the world?

AW: What we see is that the vaccination rollout, this needs to be done in conjunction with that. The vaccination rollout, it’s going to take time to get everyone vaccinated, there’s going to be individuals that are not comfortable with being vaccinated, and the demand continues to rise as people are trying to get back to work and school. So it needs to be done together and right now it’s about detecting the virus, and as soon as we can have high levels of vaccination, some of the testing is going to turn to also antibody testing, determining how effective these vaccines are, how responsive individuals are to these vaccines.

So we see throughout the first half of the year, heavy rapid testing, heavy detection testing as we move into the back half of the year. We’re also going to see more antibody testing.

But then, as we get to the end of the year, even as the virus is hopefully more manageable, we’re going to be entering the flu season for ’21 and ’22, and this may end up being more testing like we see in regular flu on a normal respiratory season. So again, the needs are going to continue.

The volumes are what’s uncertain. And our goal is to make sure that we have the capacity to be able to address both across rapid testing and antibody testing what’s needed.

MC: Well, it is truly amazing what Abbott has done in terms of bringing 300 million tests to the market in just a year so we can actually start to see this virus, which of course has been spreading silently in front of all of us and keeping us all in our homes. So here’s to a better 2021, more testing, and thank you so much for joining us. It was really a great conversation.

AW: Thank you for having me.

MC: To what extent is testing going to remain important as we start getting higher levels of vaccination across the United States and the rest of the world?

AW: What we see is that the vaccination rollout, this needs to be done in conjunction with that. The vaccination rollout, it’s going to take time to get everyone vaccinated, there’s going to be individuals that are not comfortable with being vaccinated, and the demand continues to rise as people are trying to get back to work and school. So it needs to be done together and right now it’s about detecting the virus, and as soon as we can have high levels of vaccination, some of the testing is going to turn to also antibody testing, determining how effective these vaccines are, how responsive individuals are to these vaccines.

So we see throughout the first half of the year, heavy rapid testing, heavy detection testing as we move into the back half of the year. We’re also going to see more antibody testing.

The volumes are what’s uncertain. And our goal is to make sure that we have the capacity to be able to address both across rapid testing and antibody testing what’s needed.

AW: Thank you for having me.

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INFORMATION SAFETY INFORMATION

The BinaxNOW™ COVID-19 Ag Test Card EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

The SARS-CoV-2 IgG assay has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of the IgG antibody against SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

The Abbott RealTime SARS-CoV-2 assay and the Alinity m SARS-CoV-2 assay have not been FDA cleared or approved. These tests have been authorized by the FDA under an Emergency Use Authorization for use by authorized laboratories. These tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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