Mark Massaro: Hey, guys. Congrats on a terrific quarter. I wanted to ask about – obviously, there has been a lot of interesting discussions from multiple Medicare contractors, WPS, Palmetto and Novitas. I guess it would be helpful if maybe you provided just what your expectations are on timing for, especially on Palmetto and Novitas, what are the next steps and when do you think we can get an update on any potential changes to the current policies on SCC?
Derek Maetzold: So, based upon historical trends with Palmetto, we have infrequently or very rarely seen reviews go faster than what would be required by the Medicare rules. And the Medicare rules are you need to finalize and post a final LCD 365 days after it’s posted or it kind of retires or just goes away. So in most cases, Palmetto, if you just track the data, a LCD is proposed and the data is finalized, that roughly is about a year. So that would mean kind of May of next year is probably the right timing for that. They could go faster, but that’s out of character of how they usually have operated in the past. Novitas, they don’t have a history of really updating or developing new LCDs that’s nearly as robust as Palmetto.
So that’s harder to get a handle around that. If you just take what they had proposed a year ago with the initial proposed LCD that was about 11 months, 10.5 months as well. Would they follow the same kind of pathway? That’s potentially the outside number there, Mark.
Mark Massaro: Okay. That’s super helpful. And then I think you indicated that you – in your guidance, you are not expecting squamous cell revenue from here. I guess, what informs that thought process?
Frank Stokes: We got significant feedback from a number of folks, Mark, some analysts and some investors as well that given the uncertainty around the LCD processes that are underway, that the most conservative approach would be to take that out of our guide. And so we have taken that advice.
Mark Massaro: Makes perfect sense. Last question for me, you guys are really doing a great job with TissueCypher. What is it – I mean this is 300% plus growth. What are some of the drivers here? Can you maybe just talk about, in your view, what you think is driving this and do you see a path to similar strong trends going forward?
Derek Maetzold: So I would maybe break it down into three or four elements, Mark. One is that it’s a large population of patients who are being seen, either newly diagnosed or rescoped every year. We think that’s over 400,000 patients. When we’re doing diligence, the numbers we had out of medical claim data was showing more like 300,000. So one, I just think it’s a large, underserved patient group that is seeing gastroenterologists on a regular basis. So patients are in the, either the endoscopy suite or in the office being seen for their Barrett’s esophagus, either newly diagnosed or coming back for repeat surveillance. So I think the patient flow is there. I think number two is that you do have FDA-approved devices, ablation tools.
The most important one or most – I think the highest market share one is a tool called Barrx, B-A-R-X-X, that Medtronic markets and manufactures. That has been shown in its own clinical trials to be highly effective at sort of killing off Barrett’s esophagus lesions. And when you do that, then they don’t progress to cancer, which is the goal. Now historically, even though they have FDA approval for all grades of dysplasia, the sort of society guidelines have over the last 10 years sort of say, well, maybe we should kind of limit it to the really, really risky group, which includes people with high-grade dysplasia and even now low-grade dysplasia. The TissueCypher test is able to take people who have non-dysplastic disease, which is the lowest population risk going forward and find people who actually have a disease progression risk that’s higher than low-grade dysplasia.
