So this is a very big move. And one that bodes well for MRD and potentially for other tests that we bring to market in the cancer biomarker testing space. NCCN guidelines, I think utility data is what’s typically required. I think PEGASUS will be a sort of positive piece of evidence that further bolsters the case for MRD testing. But there may need to be some additional readouts from the clinical utility perspective before we see guidelines change.
Mark Massaro: Excellent. And then my second question, the clinical volume growth of 35% was strong in the quarter. Is there any way you could break out the volume growth from either TissueNext or Reveal and then as we’re thinking about 2024, I would love to get your latest thoughts on to what extent the integration with the EMR providers can help accelerate ordering either from 360 reveal or other tests?
Helmy Eltoukhy: Let me start with the second half. The first one, this is typically a huge uplift when you are able to integrate digitally with providers in terms of how they practice medicine and how they order their battery of tests and procedures and being able to really go a long way this year and hopefully next year in terms of integrating with most of the U.S. oncology market. We think is going to be an additional growth driver. We’re doing things at the large group practice level, account levels, as we said, we’ll have over 400 accounts integrated this year. And so, there’s going to be a lot of top-down work that we’re embarking on, especially in the community type centers that we think will allow us to essentially embark on the next stage of growth, not just for the 360, but for all our oncology products.
Michael Bell: Yes. And on the volumes without breaking down into specific numbers, but both Reveal and TissueNext next year-over-year growth were both very strong. I think in previous quarters, like in previous quarter, Q2, both were year-over-year growth was over 100%. maybe both a bit slightly lower than the 100% year-over-year growth in Q3. But year-to-date Reveal is still well over 100% year-over-year growth. TissueNext very close to of 2% year-over-year. So good in the quarter, a very strong year-to-date. So again, I think we’re looking at closing the year out strong on both Reveal and TissueNext.
Operator: Our next question comes from Puneet Souda from Leerink Partners. Please go ahead.
Puneet Souda: Maybe just on Shield V2. Can you just confirm if the biobank samples that you have are untouched and sort of unutilized in any of the trials so far that you can actually use them in the pivotal trial for the Shield V2 and get that submitted. Maybe just a clarification there first, and then I have a follow-up?
AmirAli Talasaz: Yes. So the short answer is yes. More details, we have enrolled about 45,000 about 24,000 of them have been used in the first study through the CRCs that we analyze from that first 24,000, and we have 20,000 plus more patient on touch blinded – CRC’s on touch blinded asset in almost the same in our biobank.
Puneet Souda: Got it. Okay. And then just maybe one quick follow-up for you, AmirAli. I mean anything — any feedback from FDA, you pointed that the conversation is going well there, but I just wanted to see if there are any updates on that front. You pointed out about 2024 approvals still. Just wanted to get a sense of if you have any sort of guidepost in terms of earlier versus later or sort of first half versus first quarter. Anything you can provide there would be super helpful?
AmirAli Talasaz: Yes. As I mentioned it, we are continuing to make steady progress. Still we are under review. We are not done with it. And it’s very hard to predict the exact timing of it. But the confidence level is very, very high. That would be in 2024, as we expected at the time that we submitted the PMA, so continues to be the same. And the agency have been very collaborative with very collegial kind of attitude toward our application. They understand value of blood-based cancer screening, colorectal cancer screening. So we are pleased with the review cycle so far. We see how it goes.
Operator: Thank you. Our next question comes from Kyle Mikson from Canaccord Genuity. Please go ahead.
Kyle Mikson: Perfect. Hi guys. Thanks for taking the questions. My question for you, Mike. Given this G360 ASP trend benefiting from the multiple tailwinds with Medicare pricing, could you maybe just estimate, I guess, tell us if it’s possible that G360 ASP could increase to some level by the end of ’24. Look at the average revenue per test approach, maybe like 300 by that point. And then also, Mike, just a question on like cash flow as we think about getting to breakeven by the end of this year and then kind of going forward, how dilutive to cash flow generation is MRD and reveal like right now, in other words, how much of an investment there to advance that strategy like given that return so for that kind of mid-teens revenue number?
Michael Bell: Yes. Kyle, on Guardant360 ASPs. Yes, I mean we’ve seen really good traction, both on the Medicare side. We have to wait for the finalization of clinical lab fee schedule yet. But if that comes through, we’ll be closing down on 2,900 at the start of next year. And as I just mentioned on the call earlier, there are potential other tailwinds, we could see Medicare Advantage come through. We could see that also helped with private payer payments for Guardant360 LDT. So I think we’ve seen good traction. We set out on our Investor Day, it was 8 weeks ago then we wanted to get to a target of 3,000. So I think at the moment, we’re feeling very confident we can get we get north of 3,000. Definitely in the five-year time line we said on the Investor Day, but I think probably we’re trending towards that a little bit earlier than we would have anticipated and exactly where we can go.
I think we’ll have to see how these tailwinds roll out. But again, we’re confident. And then on MRD. I think we’ve broken it out before, probably the net investment on the MRD, if you take into account the cost of processing the test this year the research and development efforts that are going into it and the data development efforts as well as the sales and marketing costs, probably a net investment of around $100 million this year, give or take. And we see that likely continuing into at least 2024. Of course, the key for us, and we’re managing the volumes to try and stay manage the cash burn and yes, the key for us going forward is really to get additional reimbursement. And we’ve talked about CRC surveillance and then other indications.
So that’s what we’re really focused on with and at the same time, managing the burn.
Kyle Mikson: Okay. That was fantastic. Mike, thanks so much for that. And then AmirAli one on screening for you. The approval seems pretty likely. I think you mentioned like mid-24% around there for Shield. What’s the latest thinking there for you on the label that you ultimately attain, like second-line, third-line test. Just wondering if you discussed that with the FDA at all or maybe that’s included in the — in your opinion in this PMA submission?
AmirAli Talasaz: Yes, just to clarify, I think the mid-’24 time line that I mentioned was connected to the potential time that USPSTF review cycle in terms of some of the early data research would start based on our understanding of the process. In terms of label, we haven’t got to the label negotiation yet so far, there’s been some conversation with agency about this matter. And I think so far, so good, but we’ll see when we go to the official like label negotiation phase what happens.
Operator: Thank you. We will move on to the next questioner, Jack Meehan from Nephron Research. Please go ahead.
