Okay, we're going to kick it off. I'm Tycho Peterson from the Life Science team. It's my pleasure to introduce Guardant Health. With us, we've got Helmy, AmirAli, and Mike. Welcome to you all. Maybe we'll just start with a quick look back on Q3. You know, really strong volumes, a lot of kind of positive developments. Maybe talk about some of the highlights and some of the momentum, you know, coming out of the quarter.
Yeah, Q3 was really a tremendous quarter for us. It was really a confluence of, I think, really all our products firing sort of on all the cylinders. We had 360 Liquid. I think it was the first full quarter that we had, you know, full sort of app suite in terms of 11 new smart apps on that platform. I think we saw very strong quarter-over-quarter growth and year-over-year growth with Guardant 360 Liquid. It was also the first full quarter of our Guardant 360 Tissue launch. That test has full DNA, RNA, and methylation. And we saw a lot of excitement from the field for that test. Reveal continues to do very well in MRD and continued very strong growth there.
Obviously, continued momentum with Shield in terms of really strong quarter and really capping off, I think, one of the strongest launches in diagnostics history outside of COVID testing. Yeah, really fantastic quarter, Oliver.
There is a lot to kind of jump into there. Maybe before we do that, I just want to kind of think a little bit about the framework for next year. You know, coming into this year, you talked about mid-teens growth year over year. And, you know, at that time, I think, you know, we counted over a dozen potential upside drivers to numbers. It has been a great year. You have been kind of, you know, beating throughout. You know, as we think about 2026, and not asking you to necessarily quantify, I am just kind of wondering what you think some of the main drivers could be to the upside and how you think about that, you know, relative to, you know, the drivers you had this year.
Yeah, look, we're really in the sort of early innings of the launches of many of these products. Yeah, we see continued momentum in 2026 with all these products. I would say that we just launched therapy monitoring with Reveal in the late-stage setting with IO and chemo. You know, it's only been a few days for that, but that's off to a good start. I think that'll be a catalyst next year. We have the potential chemosestrant approval from the Serena 6 trial with AstraZeneca. That'll be a really strong footing in terms of really initiating a new paradigm of sort of monitoring with Guardant 360 in the breast cancer setting. I think that's another huge catalyst. We submitted our PMA for Guardant 360 Liquid, which is very exciting. We think that sets up a potential approval in the latter half of 2026.
I think it would be very strong in terms of the consolidation of the portfolio and what that could mean as a very strong catalyst. We saw, you know, when we got the initial Guardant 360 CDX approval, that sort of led to nice tailwinds of adoption. We think the same thing could happen here. That obviously also sets up ADLT price for that test, which could mean, you know, potential ASP improvements in terms of 360 going forward. I think Shield is really set up for a really tremendous year in 2026 as well.
Yeah, maybe I'll pick up on that last thread. I mean, it's been an impressive, you know, start out of the gate here, you know, at $24 million in revenues this last quarter. You know, we're over $100 million in our model for next year. Maybe just talk a little bit about sustainability of the growth, you know, lessons learned from the initial launch.
When you think about our $50 million on-screen patient population, we are really not even scratching the surface right now. We are in that fast scale-up. You know, we are seeing physicians are enthusiastically ordering this test. Patients are adhering and completing the test. The depth of ordering is pretty solid relative to other modalities of CRC screening. It is just a matter of increasing the breadth. We are very excited about, you know, expanding our internal efforts in terms of building the commercial channel and also some of the partnership opportunities which are going to go live early 2026. We talked about partnership with Quest and PathGroup. Partnership with Quest not only would give us access to their nationwide channel, but very importantly on the EMR integration side. We are fast-forwarding our EMR strategy by many years.
One integration with Quest effectively would make Shield an integrated testing for a large percentage of all PCPs in the United States.
You know, you shared at the beginning of this month a published study that, you know, showed, you know, Shield-based screening boosted adherence, you know, to 95%. How do you think about, you know, adherence factoring into the overall sustained growth in the CDC screening paradigm?
I think that's really a big value proposition of very routine and simple and pleasant blood testing that when the physicians are ordering the test, patients really adhere to it and complete it. We just published our experience with the first 20,000, you know, their lead time in getting the publication out. It is a little bit outdated relative to the volume that we are talking about. You know, we always talk about adherence is more than 90%. In fact, in that publication, we showed the exact number, about 95% adherence rate, which is really what you expect from blood testing. When you think about when the physician is ordering blood work for you, what percent of the times do you do the blood work? You know, effectively, it's that kind of a routine of testing that we are talking about.
We are very excited with the real-world experience with Shield testing right now.
I guess, you know, how do you think about that trade-off between performance and adherence, you know, in terms of, you know, what tests ultimately get chosen?
When we look at the CRC market in general, we believe in steady state, at least 20% of all patients are going to get tested by blood modalities for CRC screening. When you look into it, it's just a matter of throughout many years that other modalities, colonoscopy and stool-based tests have been out there. Still, we have more than 50 million on-screen patient population. Some of these modalities have been out there for about two decades. Really a new modality would be a solution here. That's the promise of blood-based testing. It's a new choice for a patient. The gold standard is colonoscopy, obviously. As experience has shown, even if you do a lot of programs around colonoscopy, around stool-based tests, still there is a fraction, a good fraction of the patients who are not going through that experience.
Blood choice is really a good complement to be on the same menu and for physician and patient to decide what they want to do.
You know, you've obviously been investing in the channel. You've been kind of clear about the spending. Maybe just talk a little bit about how the Salesforce build has gone, rep productivity, and, you know, where you think you need to be at the end of next year. Say.
Yeah, we started this year with 100 people in the field, and we are ending it with more than 250. We are very happy with the quality of the reps we added, our training program, and the productivity of the reps. Frankly, it's been the ramp of the newly hired reps has been much better than what we even internally expected. We are going to continue this build-out as we go to 2026. At steady state, we are going to have 600-700 reps ourselves. We are, as I mentioned earlier, also very excited about partnership opportunities and the relationship that we have with Quest Diagnostics and PathGroup.
You know, you raised guidance again for Shield with 3Q. Maybe just talk a little bit about, you know, where the incremental growth is coming from and any surprise, you know, from a mix perspective.
The part that we are really meeting and beating our internal expectation is really about the productivity of the new reps, how quickly they are becoming productive, the number of volumes that they are contributing. The depth of ordering of physicians is pretty solid. It is just a matter of how quickly they can go account to accounts. We thought they were going to go slower, and now they are going actually faster than what we expected. We are very pleased with what we see. The growth really has been a function of that. Still, we are just even not scratching the surface in terms of number of PCPs out there, how many accounts we are in. We are going door-to-door as fast as we can, but still we are just in very early innings. This growth would continue for years to come.
Maybe just shifting guidelines for a minute. You previously talked about ACS, you know, guidelines sometime, you know, this year. Just talk a little bit about latest thinking there and then, you know, USPSTF presumably at this point in 2028.
We are very pleased with this unexpected guideline inclusion by NCCN. It's the voice of oncology experts. It's very meaningful. Actually, we talk about now Shield is recommended by guidelines by NCCN. We are very pleased with that. American Cancer Society, we believe actually it would be in very, very near future. What we do know is they finished their review and research phase right now. Now the body of evidence is in front of the guideline committee to make the final decision. It should be in very, very near future. We are monitoring it very closely. Regarding task force, obviously there is some uncertainty of what's happening with the task force.
We decided in our investor day, you know, a couple of months ago to effectively, at just the expectation that effectively for our LRP revenue model, we are not counting on inclusion by USPSTF in terms of more than $500 million that we talked about. Now we are expecting guideline inclusion in late 2027 or 2028. Having said that, there are some interesting conversations happening between us and some other players and the new administration when we are thinking about what MAHA agenda is about, what the new administration is trying to do to make sure American technologies become impactful. We are definitely feeding that agenda. We are pleased with what we are hearing. Again, we are not counting on any kind of fast progress in D.C., but we are monitoring it closely.
You mentioned the investor day. Obviously, a lot of focus there on multi-cancer. Maybe just talk about, you know, early learnings from the launch. I guess from the outside, what should we be tracking in terms of milestones, you know, on multi-cancer for next year?
Yeah, it's kind of a historical moment for us and for the whole field. Like we envision a day that the patient during annual checkup gets the blood test. They have access to such a blood test for multi-cancer detection. And many years after, we are there now. As of October now, when the patients are getting tested by Shield, doctors have an option to opt in to receive the multi-cancer detection results report as long as the patients are opting in and authorizing us to get access to their medical record. It has actually multiple advantages for us. The main thing is around data collection initiative that we have. Hopefully in the very near future, we should have one of the largest evidence of the value of MSAT testing, especially in the U.S. patient population.
When you think about we are going to get access to the full medical record of this patient, that data treasure is going to be very valuable for us. We are very excited to see the accumulation of that data. We just started it though. Like it's just still a few weeks into it. I can tell you the reception by both physicians and patients has been pretty positive.
How about just screening age as we think about blood, you know, getting adopted more broadly? I mean, we talked about USPSTF, but in general, you know, do you continue to see the screening age being lowered?
CRC is becoming a fortunate disease of youth. I think it's a high bar for this age of 45 to go down. When you're seeing actually even some late 30s, 30s, even late 20 patients are getting actually diagnosed with CRC. When those people are getting diagnosed, more than often they're getting diagnosed with advanced stage. There is actually a healthcare crisis that at some point we need to figure out how to address. It's a high bar when you're thinking about, you know, the evidence and the prevalence of the disease, some risk factor associated with colonoscopy. I think at some point the age for screening would reduce, but probably not in very near term.
Maybe Helmy, shifting over to Reveal, you know, since you got CRC surveillance reimbursement at the beginning of the year, just talk a little bit about how that's, you know, impacted volumes and what signals you have to kind of indicate a strong ramp into 2026.
Yeah, no, we've been very pleased with the performance after we got the surveillance reimbursement indication. We've been pushing volumes there and seeing good traction. We've submitted our breast package as well. We're still going through that process. We're actually seeing good volume there with that publication, a nice ramp. We've also submitted for IO monitoring, and we've recently submitted for chemo monitoring as well, which would be the sort of first of its kind for an MRD test. Yeah, I think as we talked about in our investor day, we have probably another half dozen sort of indications in the queue and on tap. 2026 is going to be a very big year for us in terms of indication expansion.
ASPs continue to come up. You've talked about, you know, a $1,000 target by 2028. Maybe just talk a little about, you know, the steps to get there from $600-$700 today.
Yeah, I don't think it's too many steps. It's really just knocking off some of the indications that I talked about in terms of breast and IO monitoring and so on that will allow us to inch up to that level. I think we're seeing some traction with commercial payers with some of the state biomarker bills. There's 23 states now that have enacted laws that I think would qualify for essentially MRD coverage in many of those states. It's going to take some time to sort of pull that through, but we're making some progress there.
You've done a great job on COGS as well. Maybe just, you know, talk about the path from here. You're $500 by the end of this year. You've guided to, but how much, you know, additional leverage is there on the COGS side?
Yeah, no, I think Reveal COGS has been a high spot for us. You know, just over 12 months ago, COGS per test for Reveal was over $1,000. And we made a lot of workflow changes, took a lot of the sequencing costs out of the COGS per test. And so, you know, basically for this year, we've been running at, you know, less than $500 per test. You know, as we look forward, you know, we think that can continue to track down. The main driver at the moment is just going to be increasing volume. And we think that'll continue to tick down the COGS per test. Also, on the Shield side of the house, we're investing heavily in automation. We expect that we're about to use that automation in Reveal in the long term.
That might be sort of, you know, a couple of years away. I think volume is going to drive it down in the near term. Then adding in automation, we think we can get, you know, well below $400 COGS per test on Reveal.
Helmy, you've talked a couple of times about late-stage therapy response monitoring. Can you maybe just walk through, you know, how you're differentiated there, you know, from a performance standpoint?
Yeah, no, we're very excited about this test. It's built on the Reveal platform. And because we're looking at tens of thousands of cancer alterations in essentially these differentially methylated regions, we can get to very precise sort of limit of quantitation. So really, when you think about down to very low levels of tumor fraction, being able to actually have that with very sort of low standard deviation, essentially having low numbers that a physician can rely on and monitor over time. We think it is really one of the sort of best-in-class platforms for monitoring essentially response to therapy in the metastatic setting. Also because we are looking genome-wide, I think there are more features of that platform in terms of also looking at the sort of histological changes in disease.
I think the other exciting part of the platform is the fact that it's built on the same sort of railroad tracks, the same technology platform as 360 Liquid. The two tests really work hand in hand. When you think about, you know, when a physician is, when a patient is progressing, their cancer is coming back up, then the question is, what do I sort of switch therapy to sort of get that patient back on track? Because our tests work hand in hand with one another, it's very easy for a physician to sort of switch back to 360 and get another result and sort of rinse and repeat that cycle.
Maybe just thinking about, you know, some of the additional indications coming online, you know, chemo, CDK4 surveillance and, you know, five additional tumor types. What should we be, you know, paying attention to for 2026? What could be, you know, more material? How do you think about contributions?
Yeah, I think the biggest ones are going to be breast, IO monitoring, chemo, frankly. I think those three would make up the majority of indications. I think we'll sort of inch ASP forward as we sort of launch other indications in terms of, you know, whether it's melanoma or liver and other cancer types. I would say the ones I listed are probably the bulk of the potential opportunity that's out there.
You know, Reveal Ultra, maybe just talk a little bit about the, you know, rollout there. It sounds like you've got an interesting approach coming. Obviously, it brings sensitivity down to one part per million. You know, will this be overlapping indications with the original Reveal test or are there specific capabilities that you're unlocking?
Yeah, no, it'll work hand in hand with Reveal in a really nice way. And, you know, we just saw, you know, a lot of demand out there from biopharma and from many of the KOLs at ASCO for having tests that are much more sensitive than what exists today. You know, I think tumor-informed market has progressed really well. And it's been exciting to see, you know, how that demand has sort of, you know, continued to grow over time. But we're seeing a desire for going down to much, much lower levels than tests that only look for a handful of mutations, you know, 60 or 100 or even 1,000 can deliver. And so really having a level of performance that can get us to that sort of one part per million level is, I think, is really needed in the field.
We think there is a major opportunity for a test like Reveal Ultra to really fill an unmet need that currently exists. We really do not see a technological approach that is out there today that can fill that need.
Anything you can say on the rollout strategy?
No, I would say that, you know, obviously we're keeping some things close to the chest just because it's, you know, how competitive the market is. We're making great progress. The data that I'm seeing is really exciting in terms of what we can do with this platform. Yeah, we're excited to sort of share more details in the future.
Maybe just in the last couple of minutes, we'll hit on G360. Amazing quarter, right? Over 30% growth, volumes up, you know, 40%. Just talk a little bit about, you know, why the growth was so strong this quarter. You've obviously got, you know, new contributions in the portfolio.
Yeah, look, this was not sort of out of the blue. This has been, we have seen accelerating volume growth in 360 since we launched 360 on the smart liquid biopsy platform. Every quarter we have had nice additions in terms of smart applications. At ASCO, we launched 11 apps. You know, this is really the fruition of, you know, a dream we had for liquid biopsy in the sense that, you know, really being able to look at the tumor biology of disease, being able to look histologically at what is going on with disease. We can now do things like really monitor transition of tumor type from, you know, subtype from non-small cell lung cancer to small cell cancer or from HR negative to HR positive and vice versa.
Being able to see that in blood is really a new capability that physicians have never had before, doing things like negative prediction, HLA typing, and pharmacogenomics and so on. It is really a tour de force that I think has resonated with physicians. We think this bodes very well, obviously, for the coming years in terms of this platform and what we can do with it. The beauty of this platform is the fact that it is sort of built sort of hand in hand with our tissue platform as well. All these apps that we're developing that, you know, have been trained on hundreds of thousands of samples to be able to actually launch will also make their way to Guardant 360 Tissue and then eventually Reveal as well.
If we think about, you know, the growth, you're able to just touch on how much of that is, you know, some of the upgrades versus competitive dynamics?
I mean, the upgrades and the capability of the test is what is leading to product-market fit that is, you know, leading to the growth. I think that growth has really two sort of components to it. We are seeing certainly greater depth of usage among our existing physicians. That number continues to go up in terms of the number of tests per quarter that physicians are ordering from us. We are seeing greater depth in, you know, the main tumor types, but certainly the longer tail of tumor types where maybe traditionally CGP has not been ordered quite as often. We are also seeing share gains as well. When you think about the capabilities of Guardant 360 Liquid, it really is head and shoulders above anything that's out there.
We're certainly seeing physicians come back to using 360 much more so than some of the other choices in the market.
You know, just thinking about liquid, you know, I guess timelines to hear back from the FDA for the PMA submission and, you know, how important will that be in terms of, you know, driving uptake?
Yeah, no, that's a huge tailwind for us. One, it means consolidation and simplification of the portfolio in terms of really having all our products on the smart liquid biopsy platform, including our CDX product. It also means potential ADLT repricing for that test, which I think would be really exciting to see. We think that's, you know, potentially at least the FDA approval is a potentially second half of 2026 event.
Mike, on ASPs, you know, how should we think about ASPs here? You've kind of met your 2028 targets.
Yeah, I mean, when we look across the portfolio, we think there's room to improve ASPs. So, you know, Guardant 360, you know, we're at this $3,000-$3,100 range at the moment. Our focus, though, is expanding commercial coverage. We've got really good coverage, over 300 million covered lives for Guardant 360. But, you know, there's areas we can continue to expand that with different indications. And of course, Helmy mentioned potential ADLT uplift. That's more of a 2027, I would say. On tissue, I think, you know, now we can offer RNA that can give an uplift to tissue. And there's a lot of expansion in the Medicare Advantage commercial area for that. We talked about Reveal and, you know, Helmy mentioned the additional indications that we're pursuing through MolDI-X. And with Shield, you know, we've got a great start there. We've got the ADLT rate of $1,495.
Medicare Advantage payments have been incredibly strong for Shield. That has been driving this ASP that is around $900. I think we are feeling really good where ASPs are, but there is still room to grow across the portfolio.
Great. I think we're going to leave it at that. Thanks, guys. Good to start.