New Single-Swab Test for COVID-19, Flu, and Respiratory Viruses

[MUSIC PLAYING] Flu season has arrived. So I'm sure you're going to be wondering soon are the symptoms that you're having-- cough, fever maybe runny nose, is it flu? Is it RSV? Is it COVID? Well, some good news. It's pretty easy to find that out now. And the reason why is because of some new panel tests. So to help provide some insights, I've gone straight to the source. Dr. Brian Caveney is the Chief Medical Officer and President of Labcorp Diagnostics. Brian, thanks for joining me again. It's good to see you.

So good to be with you Dr. Whyte. And thank you for the great reporting that you've done throughout this pandemic. It's amazing, the number of my physician friends who have said that they routinely watch these videos and read content on the website so that they can stay up-to-date on what the real evidence is saying and what the science is progressing.

You and I first talked last year really in the height of the COVID pandemic. And since then, a lot has happened. And I referenced this testing that you all have created at Labcorp. Can you walk us through what it does and what patients should know?

Sure. So almost a year ago, we were able to get an FDA emergency use authorization for a variety of combination panels to help doctors and other clinicians determine what respiratory pathogen their symptomatic patient may have, including a combination of COVID, of course, as well as influenza A, influenza B, and RSV or respiratory syncytial virus.

As we all know, there was virtually no flu season last year because most places were on lockdown, many schools were virtual, people weren't going to work, and so there wasn't much social mixing taking place. But we sure have seen an increase, particularly in RSV over the past couple of months, and we are unfortunately expecting as many schools are back in-person this fall, as people are preparing to do more holiday travel over the coming month or two. There is likely to be a resurgence of influenza as well. So we need to be able to find those.

We have a variety of combination tests that are available for doctors to test their patients among those for respiratory pathogens. Now each of them needs to be individually clinically indicated, and that's why we have all of the different combinations. So of course, mainly pediatricians and maybe urgent cares taking care of kids that might want the one including RSV, kids under two, in particular, kids with immunocompromising conditions or taking medications that might impact their immune system. There has been a pretty significant increase in RSV over the past month.

And we have been seeing more RSV in older adults as well. As you point out, we primarily see it in children. But there are instances we're starting to see it in adults as well. So I want to ask you, is it all one swab? How does it work?

Yes, we're trying to make it as fast and convenient for the doctor, or nurse, or whoever is doing the swab as possible. First, they make the clinical decision based on seeing the patient, what needs to be tested for, what is clinically indicated, perhaps what's circulating in their local community. And then with just one swab instead of multiple, then we can test for each of the pathogens that they have ordered as part of the panel for that particular patient. Easier for the patient, easier for the clinician, and then we get the result back to them using PCR technology.

Right now, you still need to have a doctor's order. Is that correct? One can't go to a Labcorp facility him herself and say I want the test. Is that correct?

That is possible for COVID only under a variety of situations and many of those over-the-counter at-home tests are available at retail pharmacies or from our website, for example. The combination test currently needs to be ordered by a clinician. We have actually submitted the application to the FDA for a fully at-home consumer-initiated, not over-the-counter, but a consumer-initiated methodology where we would be able to provide a valid physician prescription suitable for your state.

OK. So in fairness Dr. Caveney, some people aren't going to really understand what that means. So it is as you point out, a PCR test, correct? So it's not like a rapid test. So just walk us back one more time. So OTC, over-the-counter, really means they go to pharmacy, they order online, they pick it up and they have it, and they do self collection, and they still could may or may not send it back. So tell us what consumer-initiated means?

BRIAN CAVENEY: Consumer-initiated would be a person, let's say, they have symptoms or they've been exposed to a known positive case, then they would be able to, for example, go on our website pixel by Labcorp and fill out a clinical questionnaire. If they're appropriate to be tested for COVID, then we would be able to provide the physician prescription applicable for their state and then they could get the test at home. That is not currently available for the combination panel, including influenza and RSV. We have submitted that to the FDA. We hope that it becomes available after we go through that process.

So what type of impact do you think this single panel test will have, especially as the fall approaches, weather starts to get colder or inside more? You think this is going to have a big impact?

If we do see a surge in influenza over the coming months, and in particular I'm worried about vaccine fatigue as you've been reporting on and then whether people need a COVID-19 booster shot. For doctors to have the difficult conversations to say, I also want you to get a flu shot and we want to space it out between your COVID shots, your booster shot, et cetera, I'm a little worried that the flu vaccine uptake will be low this year.

And that might be the perfect storm setup for a resurgence of influenza. If that takes place, then we believe doctors will want to rule out COVID for sure, but also potentially test for influenza in a person where they might be considering using one of the antiviral medications in order to definitively determine whether that patient has flu.

But will they get the test results back soon enough compared to some of the rapid tests that they ordered as part of this panel?

We have had many conversations with our physician customers exactly around that in the time window for starting oseltamivir and some of the other medications. We are priming our labs to be as efficient as we possibly can make them in order to turn those tests around as fast as possible to get that information to doctors.

Many urgent cares, of course, even pre-COVID have rapid flu testing mechanisms. And that is still probably going to be part of the screening protocol if they see a symptomatic patient and they're circulating influenza in their community, and in particular if that person had not been vaccinated for the flu, or if there's not a good match between the strains in the quadrivalent vaccine and the ones that we identify as circulating throughout the community this fall.

Do you feel physicians know enough about the single panel test?

We're having conversations with our customers. We're trying to create some work on our website and in information that we provide to ordering physicians around the unfortunate nature that many of the symptoms of all of these different respiratory pathogens, including regular cold viruses, adenoviruses, rhinoviruses, have annoyingly similar symptoms. It's very difficult for doctors to determine viral versus bacteria, and then whether it's something that there is a clinical reason to test for it versus treat somebody symptomatically. We're trying to help through those.

As you know Dr. Whyte, very few signs and symptoms are pathognomonic for a specific pathogen. One that is potentially helpful is an acute loss of taste or smell, is probably COVID-19 until proven otherwise. That's probably the presumptive. And we believe many doctors will test just for COVID-19 if the patient presents with that symptom. But for some of these others, nothing is going to replace the 3,000-year old good patient history, knowing your patient, knowing their medical history, and then figuring out what you think the clinical indication is for the test.

Well, this single panel test is certainly going to be another tool in our toolbox as we work to fight the COVID pandemic, as well as influenza and RSV this fall and winter. Dr. Caveney, thanks for taking the time again to share your insights.

My pleasure. Thank you Dr. Whyte.

And if you have questions about coronavirus, drop us a line. You can email me at [email protected]. Thanks for watching.

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