Dr. Luciana Borio (LB)
Randy Larsen (RL)
May 4, 2020
Part 1 – Testing for COVID-19
RL We’re very happy to have with us, Dr. Luciana Borio, a vice president at In-Q-Tel. She previously served as the Director of Medical and Biodefense Preparedness Policy at the National Security Council in the White House. Prior to that, she was the acting Chief Scientist at the Food and Drug Administration.
And in the spirit of full disclosure, I should say that Dr. Borio and I have been good friends and professional colleagues for 20 years. Dr. Borio it is a pleasure to have you join us today.
LB My pleasure to be here Randy.
RL Dr. Borio, can you tell us why is it taking us so long to develop diagnostic tests for COVID-19?
LB That’s a great question. Traditionally, it doesn’t take us that long to develop a new test. The CDC has been the public health agency that gets this whole process started when we have a new emerging infection ….one that is newly recognized. They set the bar for other developers. It takes them a few weeks and this buys time for the rest of the system, including the private developers, to come online.
This is important because Americans frequently rely on private test developers for their medical needs … tests developed by, for example, LabCorp, Quest and others. And during a public health emergency, it is helpful to rely on existing processes as much as possible.
However, this time around the situation was aggravated by two reasons.
One is that the CDC did not get this right from the beginning. They had significant technical difficulties in developing a test. So we were left with a few weeks of true agony thinking “when will we have a test?”
And the second issue that happened was that in a pandemic for a respiratory disease like COVID-19, the speed and scale of spread is pretty significant and the demand for tests exceed our capacity for the CDC – or even private developers for that matter – to produce them. So the developers could not come online fast enough to be able to meet the rapid surge in demand, especially in the early weeks.
And of course, if you don’t have diagnostic tests from the start, then you can’t really detect cases, isolate cases, conduct contact tracing to quarantine contacts …. So the number of cases keeps multiplying … multiplying by each day. The challenge grows larger because not only are you behind producing the tests, but you also have even more tests that have to be developed the next day because there’s an exponential growth of cases.
RL Okay, so in aviation terms … we call that getting behind the power curve, and once you’re behind the power curve, it is very difficult to catch up.
But one of the other things that has confused me about the initial tests … the ones where they stick that swab way up your nose … some people call it a brain swab. I guess it’s very uncomfortable going up there. But a nephew of mine had that test and it took seven days to get the results. What value is a test that takes seven days to get the results?
LB I think that’s something that a lot of people fail to recognize. If when developed early, a test doesn’t do us much good if it takes a week to get the results back.
And given the number of epidemics and pandemics that we are to expect in the future, we really have to rethink this whole test development strategy Randy. There’s no reason from a technology perspective that we shouldn’t have rapid, accurate tests for people at their point of care … at their doctor’s office, clinic or hospital…even at drug stores and perhaps even their homes. Additionally, the results of these tests should be made available quickly to public health officials, so the aggregate data can be quickly analyzed and actions taken to curtail the epidemic.
It’s the whole system that needs to be revamped.
What I’ve learned over the years, specially working at the National Security Council, is that certain functions really belong to the private sector and it’s in their interest to move ahead and develop their systems because there is a commercial market for those goods and services, and there are certain things that truly belong to the public sector and it doesn’t do us any good to fund things that the commercial market would have done anyway.
Conversely, we need to pay attention to things where the commercial market will not meet the needs of public health and national security. Getting this right is going to require a lot of collaboration between the private sector and the government.
RL Ok…next question…antibody testing. I have friends who say, “I was pretty sick back in February. I may have already had this COVID-19.” So tell us about antibody testing. I understand there’s lots of companies out there selling them, but Caveat Emptor, right?
LB Yeah, so many complicated issues around that, and I think in principle, it’s really a great idea to be able to … with a very small amount of blood sample a little pinprick to assess whether one has the antibodies against the virus that causes COVID-19.
So some of the limitations that we have is that we don’t know whether having antibodies really confers protection from the virus … SARS-COV-2.
We’re still learning a great deal about this disease. So just having the presence of antibodies does not necessarily provide protection. We think it does but we need more data. The second issue is that, technically speaking, there’s a lot of rigorous scientific work that needs to be done in the lab to validate these tests. It’s not uncommon for antibodies to cross-react with other similar pathogens.
So it’s very important to make sure that if you have a positive test, it truly is a positive test against the virus of interest, in this case the SARS-COV-2 and not, for example, the coronavirus that causes the common cold.
In this regard, itis very important to have a strong FDA that is providing oversight for these tests because they really establish a benchmark that the American public has grown to trust and depend on. That’s why the FDA exists.
And one more thing one about antibody tests that I think is important to understand. No test is a hundred percent accurate. If the prevalence of disease in the population is still relatively small, there’s a chance that the positive result is not a true positive.
If the prevalence is only about 5%, as many as half the positive results could actually be wrong given the performance of certain tests that are presently available.
So the interpretation of a test, even if the little kit itself works really well … is still highly dependent on the actual prevalence of disease in the population. We don’t know exactly what the percentage of people really have been exposed. And even if we contemplate that maybe 10 or 20 percent have been exposed. That’s still not the majority, so a lot of positive tests will be false positives (that is, the test result is positive, but the person never had the infection).
RL So what I’m hearing now is that we’re a long way away from having a test that tells me it’s okay to really start going out in public again or going to large events.
LB We’re a long way away from that. That’s right. You’re not going to get little immunity passport card.
RL Okay, but do you think that is possible in the future?
LB I don’t know. I don’t know whether it’s going to be possible. It really depends on whether we can get the science right, and I don’t think we are going to make a perfect test … or you know, be right a hundred percent of the time.
RL Okay. I greatly appreciate your assessments and comments on testing. Next topic, vaccines.