Friday, April 03, 2020 4:57:17 PM
Q&A, #8, OPGN, Q4 2019 OpGen Inc Earnings Call,GAITHERSBURG Apr 2, 2020 (Thomson StreetEvents) -- Edited Transcript of OpGen Inc earnings conference call or presentation Tuesday, March 24, 2020 at 8:30:00pm GMT
https://finance.yahoo.com/news/edited-transcript-opgn-earnings-conference-044658116.html
TEXT version of Transcript
https://finance.yahoo.com/news/edited-transcript-opgn-earnings-conference-044658116.html
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No, the BGI test kit.
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Oliver Schacht, Curetis N.V. - MD & Member of Management Board [33]
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Got it. Okay. Understood. Sure. Look, I mean, the one thing to realize is, as you said, it's a very fluid, very dynamic situation. There's a substantial universe of opportunities for COVID-19 testing, be it at almost home testing for antigens, there's more and more tests coming out that way, all the way through the ultra-high throughput Roche-Clovis platforms, which, honestly, those types of platforms are likely going to take the bulk of the sheer volume when you look at central labs processing thousands, if not tens of thousands, of tests in a very short order.
Where the BGI test kit fits in is really that middle segment. The Thermo Fisher ABI 7500 is really a workhorse of the PCR landscape. It's a well-established, widely distributed platform both in Europe and the United States. But in Europe, it's been around for a long time. It's got a lot of fans, a lot of labs. They're sort of in the lower to medium volume. But it's a simple platform, doesn't require the capital outlay. If you go farther out into Eastern Europe or Southeastern Europe where you have fewer and fewer labs that have sort of the latest and greatest Roche COBAS TaqMan platforms, but they do often have these ABI 7500 workhorse platforms.
So we're playing in this, let's call it, medium-volume throughput against a standard 96-well plate. So it's not onesies and twosies, but it's also not designed to do 10,000 tests in a single shift. So in that midrange -- and again, that's the sweet spot and that's really where the focus is, getting those tests in the hands of all of those labs who have that platform readily available.
If you look at the pack insert and the instructions for use and you look at it from a technical standpoint, frankly, there's also no reason to believe these reagent kits, and this is true for the BGI kit but also many others that are out on generic PCR equipment, would not also work on many other PCR platforms. But of course, this being a regulated CE-marked diagnostic, it has been validated on the ABI 7500.
Now if folks are looking at this from [getting acute] and looking at other PCR platforms, I would not be too surprised if it works equally well on a bunch of other platforms. We know it works on other Thermal Fisher platforms as we have some of those in our own labs. We're not promoting it actively for those, but it's certainly something that, as things evolve, can be looked at in terms of expanding the universe of instruments this can run on.
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Maxim Jacobs, Edison Investment Research Limited - Managing Partner & Director of Healthcare Research for North America [34]
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Great. That was very helpful. I was just wondering, what's the prospect of developing a test for the U.S. market?
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Oliver Schacht, Curetis N.V. - MD & Member of Management Board [35]
--------------------------------------------------------------------------------
Well, the BGI test kits has been FDA-cleared under the Emergency Use Authorization. Given our long-standing strategic partnership with BGI, is this a conversation we're having with them? Absolutely. Now BGI also has its own direct commercial channels in the U.S. So no decisions have been made there. But the test is, in principle, available in the United States by now. Where they are in terms of inventory, I have visibility on their European operations because their European affiliate is in Germany and in Denmark. So we have good visibility on the bulk volume that's coming through there out of China. I don't have that visibility on any available test kits in the United States, as in are they physically available there today. But from a regulatory standpoint, as of last week, this has been emergency use authorized by the FDA.
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Evan Jones, OpGen, Inc. - Director [36]
--------------------------------------------------------------------------------
And Max, Evan here. Just wanted to add that on the call script earlier, we talked about the potential of adding the coronavirus test to the Unyvero LRT panel. If that goes forward, that could be moved into the North American market under the Emergency Use Authorization fairly quickly. And then we're also looking at other opportunities. But one thing we don't want to do is just duplicate some of the activities that have already been done by others. So I think you'd look to the company to make smart strategic moves here while it capitalizes on its position on the 2 products that I just mentioned.
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https://finance.yahoo.com/news/edited-transcript-opgn-earnings-conference-044658116.html
TEXT version of Transcript
https://finance.yahoo.com/news/edited-transcript-opgn-earnings-conference-044658116.html
=======================================================================
No, the BGI test kit.
--------------------------------------------------------------------------------
Oliver Schacht, Curetis N.V. - MD & Member of Management Board [33]
--------------------------------------------------------------------------------
Got it. Okay. Understood. Sure. Look, I mean, the one thing to realize is, as you said, it's a very fluid, very dynamic situation. There's a substantial universe of opportunities for COVID-19 testing, be it at almost home testing for antigens, there's more and more tests coming out that way, all the way through the ultra-high throughput Roche-Clovis platforms, which, honestly, those types of platforms are likely going to take the bulk of the sheer volume when you look at central labs processing thousands, if not tens of thousands, of tests in a very short order.
Where the BGI test kit fits in is really that middle segment. The Thermo Fisher ABI 7500 is really a workhorse of the PCR landscape. It's a well-established, widely distributed platform both in Europe and the United States. But in Europe, it's been around for a long time. It's got a lot of fans, a lot of labs. They're sort of in the lower to medium volume. But it's a simple platform, doesn't require the capital outlay. If you go farther out into Eastern Europe or Southeastern Europe where you have fewer and fewer labs that have sort of the latest and greatest Roche COBAS TaqMan platforms, but they do often have these ABI 7500 workhorse platforms.
So we're playing in this, let's call it, medium-volume throughput against a standard 96-well plate. So it's not onesies and twosies, but it's also not designed to do 10,000 tests in a single shift. So in that midrange -- and again, that's the sweet spot and that's really where the focus is, getting those tests in the hands of all of those labs who have that platform readily available.
If you look at the pack insert and the instructions for use and you look at it from a technical standpoint, frankly, there's also no reason to believe these reagent kits, and this is true for the BGI kit but also many others that are out on generic PCR equipment, would not also work on many other PCR platforms. But of course, this being a regulated CE-marked diagnostic, it has been validated on the ABI 7500.
Now if folks are looking at this from [getting acute] and looking at other PCR platforms, I would not be too surprised if it works equally well on a bunch of other platforms. We know it works on other Thermal Fisher platforms as we have some of those in our own labs. We're not promoting it actively for those, but it's certainly something that, as things evolve, can be looked at in terms of expanding the universe of instruments this can run on.
--------------------------------------------------------------------------------
Maxim Jacobs, Edison Investment Research Limited - Managing Partner & Director of Healthcare Research for North America [34]
--------------------------------------------------------------------------------
Great. That was very helpful. I was just wondering, what's the prospect of developing a test for the U.S. market?
--------------------------------------------------------------------------------
Oliver Schacht, Curetis N.V. - MD & Member of Management Board [35]
--------------------------------------------------------------------------------
Well, the BGI test kits has been FDA-cleared under the Emergency Use Authorization. Given our long-standing strategic partnership with BGI, is this a conversation we're having with them? Absolutely. Now BGI also has its own direct commercial channels in the U.S. So no decisions have been made there. But the test is, in principle, available in the United States by now. Where they are in terms of inventory, I have visibility on their European operations because their European affiliate is in Germany and in Denmark. So we have good visibility on the bulk volume that's coming through there out of China. I don't have that visibility on any available test kits in the United States, as in are they physically available there today. But from a regulatory standpoint, as of last week, this has been emergency use authorized by the FDA.
--------------------------------------------------------------------------------
Evan Jones, OpGen, Inc. - Director [36]
--------------------------------------------------------------------------------
And Max, Evan here. Just wanted to add that on the call script earlier, we talked about the potential of adding the coronavirus test to the Unyvero LRT panel. If that goes forward, that could be moved into the North American market under the Emergency Use Authorization fairly quickly. And then we're also looking at other opportunities. But one thing we don't want to do is just duplicate some of the activities that have already been done by others. So I think you'd look to the company to make smart strategic moves here while it capitalizes on its position on the 2 products that I just mentioned.
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