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LabCorp receives FDA authorization for at-home COVID-19 kits

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Yahoo Finance’s Alexis Christoforous and Brian Caveney, Labcorp Diagnostics President, discuss the latest at-home COVID-19 test kit.

Video Transcript

ALEXIS CHRISTOFOROUS: LabCorp has now become the first company to receive FDA approval to sell its COVID-19 test kit over the counter without a prescription.

Joining us now Brian Caveney. He is the President of Diagnostics at LabCorp. We're also joined by our Health Reporter Anjalee Khemlani.

Brian, thanks for making time for us. This is certainly exciting news for LabCorp. It's exciting news for the public at large. I think everybody wants to know, how does this test work? And then when can we actually find it at our local retailer?

BRIAN CAVENEY: Well, thanks so much, Alexis. I appreciate it.

The great news is this is exactly the same as the other testing that we offer in all of the other channels, whether you go to your doctor's office, an urgent care, get it through telehealth, one of the drive-through sites at a retail pharmacy, or, frankly, on our website for several months at pixel.labcorp.com. This is just adding another channel to be able to buy it over the counter from retailers so that people who need the test, according to the CDC guidelines, can get access to it in a very convenient fashion.

ANJALEE KHEMLANI: Brian, Anjalee here. I know that this is something that obviously a lot of people have been waiting for. There's been such a push for rapid at-home or just a nonprescription test. Harvard expert Dr. Michael Mina-- I'm sure you've heard of him-- has been pushing for these rapid antigen tests, and he made a really clear point today about the availability. Listen for a second to what he had to say.

MICHAEL MINA: We have a lot of people saying these tests can't be trusted in the hands of the average American, but then we have the rich and wealthy and famous of our country-- we have Hollywood is using these. The NFL is using these. The White House is using these. The important people in our communities-- and by that I mean the rich and famous-- are using the tests. But then we have a system that is stopping the average person from getting these very tests.

ANJALEE KHEMLANI: So, you know, we're listening to a push for antigen tests, which is different. I know that PCR is the gold standard, and it's obviously something that the company is pushing. What are your thoughts on rapid antigen tests and the need to get them out into the community?

BRIAN CAVENEY: Well, thanks, Anjalee. We're also certainly looking at those and working with those and working with a lot of our customers across the country when that is a good option.

This test that we have launched yesterday is actually standard PCR using the same high-quality equipment in our laboratories of a test you may get from your doctor's office. The great news is we've worked very hard with the FDA scientists to validate every step in the process, as Dr. Mina says, so that people can follow the directions very easily, collect a good sample, send it back to us, and we can give them a very high-quality result as quickly as possible.

ANJALEE KHEMLANI: I know that that's one of the things that is the concern. The FDA has had, you know, the say in it, and there's been questions about whether or not there are too many regulatory hurdles to get as many rapid antigen tests as is necessary out, especially knowing that some of these tests are being produced here and being sent overseas. I just wonder on your thoughts on that, you know, with your experience. Is there a way around it, and should we be getting more of these on the market versus the PCR tests?

BRIAN CAVENEY: We favor getting as many high-quality tests as possible on the market. There are different use cases and situations where different types of testing are most appropriate. For a very low-risk population being screened where the pretest probability is extremely low, the rapid antigen test that gives a negative result is very reliable. And likewise if someone has a very high pretest probability of having the disease and has all the symptoms of COVID and an antigen test is positive, then it's probably positive.

For all of the other situations that may occur, the PCR test is a little bit more reliable, more sensitive, and perhaps a better answer, particularly for a doctor trying to make a decision on how to treat a patient that may have symptoms.

ANJALEE KHEMLANI: So what I hear you saying is that we should sort of stick to keeping those regulatory rules in place.

When we're looking at it broadly, what LabCorp has been able to do-- I mean, one of the two biggest companies being able to take on as many swabs. Can you just go through the timeline? When we started in January and February seeing these cases, how much more in terms of equipment, in terms of, you know, vendors and et cetera for all the testing kits have you had to scale up in that time?

BRIAN CAVENEY: It's one of the things I'm most proud of our company for having done. Back on March 5 when we were the first company to be able to do commercial lab testing for COVID, we were only able to do really a couple of hundred tests per day, maybe a few thousand that first week. And then now we can do almost 270,000 per day across the United States, and we've done it in many different fashions.

We are now performing the testing in 21 different laboratories across the US using eight different platforms. So we've diversified our supply chain across the globe as much as possible, from the equipment, the consumables, the reagents, the other supplies.

And then, of course, we've also had to dramatically increase our workforce and train them to be able to use these very sophisticated machines. We've hired thousands of people since March in order to help us perform all of this testing as quickly as we can so we can get those answers back to patients and their doctors as soon as we can.

ALEXIS CHRISTOFOROUS: Brian, I'm curious if you have been in touch with the incoming Biden administration as they are going to be taking over the reins at the White House in January. Have you been in touch with their team, and what can you share with us?

BRIAN CAVENEY: Absolutely. Just like we worked every single day with the regulators at the CDC, the NIH, FDA, and on the coronavirus White House Task Force all throughout 2020, we have had early conversations with the incoming administration. We want to make sure that they understand how the laboratory industry across the country has stepped up and done whatever it takes in order to expand our capacity, address the need, provide all of the data every day for all of the testing that we do to all the state health departments, the CDC, and other regulators. And we stand ready to do whatever is necessary to come together, collaborate, and make sure that we are performing all the testing that we can for the country in this time of need.

ANJALEE KHEMLANI: And, Brian, a final question for you. We're seeing such stark numbers and surges around the country, whether you're talking about confirmed cases, hospitalizations, as well as deaths. We know that post-Thanksgiving that picture is not yet full, but post-Christmas and the holiday season, we're really going to see those cases rise. What are you doing right now to build up for that or in anticipation of that? Are we going to see delays in turnaround times?

BRIAN CAVENEY: Such a good question. We are doing everything we can. As I mentioned, we're working with every one of our suppliers and manufacturers to buy every piece of equipment we can, to hire and train more workers to be able to handle the expected surge that might take place. We're innovating wherever we can to be able to speed up the extraction process before they go into our machines. We have approval for matrixed pooling in order to take low-prevalence samples and combine them together to increase our throughput. And working as efficiently as we can with our customers, which are primarily the doctors and hospitals of America, to make sure that they're doing appropriate testing, following the CDC clinical guidelines where they can, and taking-- and helping them take care of their patients the way we can.

The entire lab industry has collaborated incredibly well throughout the whole year-- all of the private labs, the hospital labs, the public-health labs in order to increase our capacity and try to handle the demand the best we can. The best thing we can all do is follow Dr. Fauci and other public-health advocates' advice and be very careful throughout the season. But if you do need a test, if you're symptomatic or if you are exposed to people who have had COVID-19, then get appropriate testing through one of the different avenues, and we can all hopefully take care of this together.

ALEXIS CHRISTOFOROUS: And, Brian, I guess it's important to note, though, that this should not take-- this test, this at-home test without a prescription should not take the place of a doctor's visit, correct?

BRIAN CAVENEY: Well, this is the same exact test that you might get from a doctor's office, and so it's just another way of getting the same test. You can buy it at a retailer once we make that available without a prescription up front, but then you'll register it on our website and follow some clinical questionnaires to make sure that it's appropriate. And then if-- unfortunately for the people who will be positive from the test, they will still get a phone call from a health-care professional to walk them through exactly what to do with that positive test to make sure that they get the appropriate health care if needed. And then, of course, we also submit all of the results to the public-health authorities for all of the data-tracking purposes that we all follow on a daily basis.

ALEXIS CHRISTOFOROUS: And the test is still covered by insurance for the time being. Do you know how much longer that might be the case, Brian?

BRIAN CAVENEY: We are working with all of the managed-care plans to make sure that we continue to promote the appropriate use of the test in clinical situations following the CDC guidelines. We're currently under a public-health emergency and working with the federal government and private and public payers to get it reimbursed where we can. And as that policy emerges, we'll stay on top of it and make sure our customers are aware.

ALEXIS CHRISTOFOROUS: All right. Brian Caveney, president of diagnostics at LabCorp, and our health reporter Anjalee Khemlani, thank you.