Gajus V. Worthington
Analyst · Matthew Pommer of Oppenheimer
So let me start with the diagnostic strategy, and I'll go back to your question about the impact of regulatory work on our product margins. So our diagnostic strategy is very simple. We would like to be in a position to provide our tools to clinical customers who wanted to utilize them. The -- that very well may require, at some point down the road, that we get regulatory -- FDA regulatory approval for one or more of our products, and that includes a reach through into manufacturing, of course. So the applications are varied. Certainly, there's a lot of interest in circulating tumor cells. There's been a lot of interest in advanced cancer diagnostics, new cancer diagnostic that utilize single cell. But there's also a lot of existing things, and I mentioned this earlier in the prepared remarks, that or actually -- sorry, it was a question, the Access Array, which does not do single-cell generally, is being utilized more routinely for sequencing applications at our clinical. So in any case, eventually, our customers might really need us to get regulatory approval for one or more of our products. And if we decide to do that, then there will at least be a transient effect on margins, as we'll have to do a substantial amount of work, mainly related to documentation and perhaps somewhat related to the flow of manufacturing. But those things will cost more as we're implementing them. And thus, could provide some headwind for margins while we're doing that. We haven't made a decision to do these things yet. And if we do, we'll certainly let you know. And then at that time, we could probably give you some specific guidance about how that might affect margins going forward. But for the time being, there's nothing in the near term, the very near term that we see affecting our product margins. We will have some amount of headwind as a result of the expansion of our manufacturing facility in Singapore. The bulk of that will transpire next year. But the other reasons that we encourage you to continue modeling us in the high-60s obtain [ph] that, we said them already, that we want to reserve pricing flexibility for high-volume customers. And I've already spoken about the potential for impact from regulatory efforts.