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Fulfilling demand for COVID-19 testing as travel returns

Dwight Egan, CEO of Co-Diagnostics, talks about his company's efforts to bring reliable COVID-19 testing to public spaces and eventually homes, as health officials prepare for travel to surge as the holidays approach.

Video Transcript

SEANA SMITH: At-home COVID tests-- we know that they are a priority of the Biden administration. The White House has taken steps to invest more money into these types of tests. So we want to bring in one of the big players in this space. For that, we have Dwight Egan, CEO of Co-Diagnostics. Dwight, it's good to see you again. I know you currently sell a lab-based PCR test, now you're developing an at-home PCR test. Talk to us just about how that process is going and how critical at-home testing is in your view as we head into the holiday season, and as cases rise.

DWIGHT EGAN: It's good to be with you again. The at-home testing and point-of-care testing is a very, very important aspect of how we approach the COVID-19 pandemic going forward. It's sort of a multimodal, three-legged stool approach that the world in the country has to adopt. They have to have a focus on testing, of course, a focus on vaccination, and also focus on the new forthcoming therapeutics.

So we've been working on a platform that we refer to as the Icon Platform since a year ago May. So it's been a long project in putting together what we think is the optimal solution for testing. It's a fast, accurate PCR, gold standard accurate, and inexpensive way to test. And what has to happen in our schools, and our businesses, our restaurants, and in our homes is we have to operationalize testing so that individuals have the power to know their COVID status-- and not just their status with COVID, but their status with COVID as it relates to other diseases that present with similar symptoms, such as the flu, or strep, or other things.

So we've developed a very elegant product. I have to remind you that this is something that is subject to FDA review and is not currently for sale. We've done a large user factor study recently and will shortly commence our clinical trials. And we hope to be able to submit this to the FDA by the end of the year.

ADAM SHAPIRO: OK, so submit by the end of the year. What would be do you think the timeline for approval? And then if it got approval, how much would this cost each individual household to have one of these tests? And then the follow-up to that would be, is it going to be necessary if what they're telling us is that this is going to be an endemic kind of existence, humanity and COVID going forward, kind of like the flu, would people be willing to spend the money to have this in their home?

DWIGHT EGAN: Yeah. On your first question, of course, it's up to the FDA as to how long it takes for them to approve it. They have recently announced that they are prioritizing these types of at-home and point-of-care testing solutions, because we really have to get there as soon as possible. So you know, the timetable is FDA-driven. But we think that it will be looked at with some level of urgency and hope that that would be the case.

With respect to cost, this is truly an at-home and very accessible type of device. It's estimated to cost around $300 for the device, and the testing little cartridges in the $15 to $20 range.

SEANA SMITH: Dwight, when it comes to production, I guess how quickly can you scale manufacturing and the supply chain issues that we're facing? A number of industries, obviously, facing this challenge-- do you see that potentially holding up things going forward?

DWIGHT EGAN: Well, we don't foresee any supply chain issues. And we are going to be manufacturing this, at least initially, in the United States. And so, you know, we've already been in manufacturing at a certain level to conduct the studies that we've been doing and the studies that we'll continue to do. So we're going to be trying to produce as many of these instruments and sample collection cups as we can, and we're trying to do it domestically.

ADAM SHAPIRO: Dwight, who would the business-- or what would the business model really focus on? Would it be businesses to have the test or, like, cruise ships-- that makes total sense before you let people get on a ship to have them do this kind of test. But would people really want to have this individually in their homes? Because $300 does seem like a lot of money.

DWIGHT EGAN: Well, for people who can't afford the $300, we believe that this is something that would be available certainly in our schools, in our businesses, in our restaurants, on cruise ships and hotels. So we think it's very accessible from a pricing standpoint. And remember, this little box is reusable, over and over again, will last for years on a bathroom counter.

This is not a system like some systems where you take the test and throw everything away. The consumable is the little sample cup that takes the saliva or nasal swab sample from the patient, and then it goes in. So it can be also used in doctor's offices and dental offices. You know, during the pandemic, if we had just been able to get our dental offices-- there's 186,000 of those around the country.

If they had all had the Icon Platform, could have made a big dent in testing. So doctors offices, dental offices-- about anywhere you can imagine that's either point-of-care or at-home is where we anticipate this device being useful.

SEANA SMITH: Dwight, we know that this has been a priority of the administration. Like I said before, they've allocated millions and millions of dollars to enhancing at-home tests. Do you think the administration-- or what else should the administration be doing in order to expand the accessibility that we currently have to at-home tests?

DWIGHT EGAN: Well, I think they've really got their pedal to the metal on this. The administration seems to be very engaged in providing both funds and emphasizing the necessity of getting these tests out and these types of platforms out. So we've been working feverishly to get a solution. And we're very, very proud of what we've done.

We've engaged some of the best scientists in the world to make it so we have, like, a set of fast, PCR, gold standard accurate inexpensive platform for both at-home and point-of-care. It's really getting the power to know on an individual basis.

And people need to take some personal responsibility for their COVID status. They shouldn't be going to a game at an arena or to a theater to see a movie without knowing what their COVID status is. We shouldn't be subjecting one another to that kind of guesswork.