Thanks. We're going to kick it off. I'm Tycho Peterson from the life science team. It's my pleasure to introduce Guardant. We've got Mike and Zarak with us today. Maybe to kick it off, Mike, I'll flip it over to you to just do a quick recap of 1Q. Obviously, impressive relative to the Street on screening and oncology. Just talk about some of the momentum you have coming out of the quarter.
Yeah, thanks. Thanks, Tycho. Yeah, no, Q1 was a great start to 2026 for us. Our overall revenue growth was 48% year-over-year. It's the fastest revenue growth we've seen for the last five years, of course, off a much bigger base, so we're really pleased at that. We tripped the sort of trailing 12 months billion-dollar revenue run rate. I think all bodes well for us there. We saw broad-based strength in Q1. Oncology was very strong. The volume growth was 47%. That's the best we've seen in the last three years. Again, that was broad-based. Guardant360 did extremely well. That's growing 30%. Tissue did well. It's our second fastest-growing oncology, and Reveal was a real highlight that grew over 100%. We're seeing a lot of traction on Reveal within MRD and also with therapy monitoring.
Then, yeah, on screening, a very good start to the year. Did 44,000 tests. We saw really good momentum in March in exiting the quarter. I think initiatives like our Quest collaboration, and direct-to-consumer initiatives that we started now are really starting to play into the numbers. We were really pleased with the start, and yeah, it sets us up well for the rest of the year.
You obviously took up the guide on both oncology and screening. I guess, as we think about whether it could be upside and maybe even going forward a year, is it more from the guideline updates, from NPIs, from some of the partnerships you just mentioned?
Yeah. I think we had a lot of confidence coming out of Q1 with the traction that we saw on the oncology side of the business with the Smart Apps continuing to really drive volume on the liquid side. Therapy monitoring, new product that we launched in Q4 of last year, we've seen really good uptake of that, and that gave us a lot of confidence to up the guide. I mentioned on screening, the momentum we saw in Q1 and our expectation for Quest and the impact of DTC was really baked into that guide uplift. A couple of things that we said weren't included in our guide and then have since come to fruition in the last couple of weeks was the FDA approval for Guardant360 Liquid, and then the ACS guidelines. Both of those hit just in the last couple of weeks.
They weren't in our guide, so we sat here with even more confidence in the numbers we put out.
On screening, it's great to finally get the ACS guidelines going through last week. Just talk about how you think about uplift there on volumes this year and next, and what does timelines now look like for commercial coverage?
Yeah. I think on the ACS guidelines, first of all, we were really pleased with the guidelines. I think the way that they're written with respect for those patients who don't want to do a colonoscopy or a stool-based test, it effectively mirrors the way that the sales team has been selling Shield. It's really how we've positioned that, which is there's a 50 million unscreened population out there, and we've been going into doctors and really targeting those patients that don't want to do any other modalities. In the past, those modalities have been ordered, and the patient hasn't followed through with them. We think those guidelines just back up how we're selling that, and they give us a lot of additional validity around the test.
I think we see those ACS guidelines on a national basis just helping with the sales message and helping continuing to drive the volume across the U.S. Of course, there are roughly a dozen states where it's mandated for commercial payers to cover the test once they're in ACS guidelines. In those states, in particular, I think two things. One, we'll now open up the volume to the under 65 to that commercial payer patient population. We've been sort of holding back in the rest of the U.S. on that to date. We can open that up. That can be a volume driver. Of course, we'll be pushing as hard as we can with the commercial payers to start to update their coverage policies to cover the test and to start paying us.
We expect it's going to take potentially up to sort of 12 months to really get to a place where we want to be with commercial payers. I think initially we'll get quite a number of denials, but as we sort of speak to them and work with the commercial payers, we're sure that they're going to be updating their coverage policy. We see ACS having a positive impact on volume for the remainder of 2026, and then probably more of a revenue impact from those ACS states in 2027.
How about the $700 ASP in your long-range plan that you put out for 2028? Does the guideline update change the thinking there at all?
It doesn't change the thinking on the 2028. I think the dynamics that we expect to see on ASP, we'll open up to those under 65 in the ACS states. Well, initially, we'll be getting a number of zeros ahead of when we start to get paid. We expect a little bit of a hit initially on our ASP. It's been trending over $800 today. If you look at the rest of our guidance, we wanted to set the right expectations for the remainder of 2026. Our guidance for the remainder of 2026 is on average $775. That anticipates we'll be getting some zeros, over time, we would expect when we start getting paid, that to tick back up. I think in our 2028 LRP, we're expecting the same sort of phenomenon from USPSTF.
Once we're in guidelines there and our base case assumption is end 2027, start of 2028. Again, we'll open up to more commercial volume. Initially, that'll be zero-pay, the payers will start to pay us, and that'll tick back up. We look at $700 as being sort of a low water mark, as the commercial payments ramp up, it'll be ticking back up and we think longer term it'll be at least over $800.
You just mentioned USPSTF. What's kind of the longer-term view there? We haven't seen the draft guidelines. You've got leadership changing hands. Are you still constructive on the idea Shield can get USPSTF inclusion?
Yeah, we're still constructive. We see all the noise that's happening around this, and that group's been disbanded. We're hopeful that it gets put back together in the near future and that it can start its work. We have a very active team in D.C. I think the signals we're getting and that we're hopeful for is that that group will be put together soon and start its work, and hopefully, one of the key things that they're going to focus on will be updates to CRC. Yeah, we're still hopeful of getting there by late 2027, 2028. Of course, it's out of our hands. The signals we're getting, potentially this could move at some point in the near future.
Just thinking about multi-cancer, how's opt-in fared in the early days here? Has it driven a tailwind on volumes, or is it more about supplementary features for real-world data?
Yeah, multi-cancer's been great. I don't know, Zarak, if you want to maybe-
Sure. Thanks, Tycho. We're super excited about MCD or multi-cancer detection. That feature was rolled out in Q4 of last year. We continue to see very good attachment of this opt-in from physicians and patients in the last two quarters. Feedback's been great, this is helping to populate this data collection initiative with a lot of samples that we're going to work towards a regulatory filing over the coming years. We think we're really well-positioned to be the winner in multi-cancer over time.
How do you think about MCD monetization, given the current offering's not paid? What's the path there?
Yeah, it's something we think a lot about. Clearly, there needs to be a lot of work to develop I think a better or more robust framework for reimbursement for MCD. We applaud Congress for this first step, which is the MCD bill, which creates the first phase for reimbursement for MCD. We're going to continue to work to improve that over time. In parallel, yeah, we're running through the data collection initiative. We're collecting samples and fine-tuning the assay, so that we can get towards FDA approval and monetizing the effort over time.
How about just competitive dynamics? You've got some rising competition in CRC and MCD overall. As we think about more entrants into the market, is there a need for Shield 3.0 at some point?
We don't think there's a need for Shield 3.0. I would say the team always continues to look at improving the test. We continually working at that. As Zarak mentioned, we've got a differentiator with multi-cancer. We're of course working on lung. That study is ongoing, but we would expect a readout on lung at some point in 2027. I think there's a lot that we're doing on the development side to continue to progress Shield. On the commercial side, I think we've been anticipating competition now since we launched on day one. We knew that competition is always coming down the line. I think all of the things that we've been doing over the last almost two years now in building out a very significant commercial infrastructure. We ended last year with over 300 people in the field. We see our sales productivity going incredibly well.
The Quest collaboration that went live towards the end of Q1, we think that's given us a massive step up in our connectivity just on the EMR system, and very importantly in these 8,000 blood draw centers with Quest. That's creating a very significant moat for us. I think the DTC initiative that we kicked off in Q1 on top of the HCP marketing that we've been doing for the last two years, positions us very well for competition coming down the line. I think anecdotally now, we think there's incredibly strong brand awareness of Shield. When our reps are going into new accounts to talk about Shield for the first time, in most cases now we're finding that the doctors have already heard of Shield, either from the HCP marketing that we're doing or patients coming in and have seen the Shield test now with the DTC.
I think from the development side and also from the commercial side, we feel in a very strong position, and we know that, yeah, competition's coming down the line.
Has the consolidation that started to pick up change your view on just the commercial footprint you need?
No. I think, again, we've always sort of had this assumption on competition, and I think we've had our eyes and ears out for a long time understanding how the market's going to develop. We've always said, at scale, by 2028, we'd expect to have something like 600, 700 people in the field. We're making very good progress with that, and we're moving very quickly. We think that's the right number for that time period. One thing that we're really happy with is that sales productivity. A lot of that is driven by the very strong adherence rates that we're seeing with Shield. They're well over 90%. Yeah, over 90% of the time when the doctor orders Shield, the patient's going to get in the blood drawn, and we actually get the test and can report out a result.
That strong adherence is a very good message, but it also makes our sales team very efficient because rather than chasing up patients to make sure they actually get the test done, they're focusing on new accounts and driving breadth of accounts as well as the depth of accounts. We think that 600, 700 is a good target for us to set for 2028.
Just maybe last one on Shield. It's been kind of a gating factor on reaching cash flow breakeven. Obviously, at a corporate level, you're talking about the end of 2027 4Q.
Yeah.
Anything to change that kind of trajectory, like do the guidelines maybe pull that forward or not?
Yeah, I think, first of all, on cash flow breakeven, I would say, we are at pains to point this out. Excluding screening, the rest of the business, and that's loaded with pretty much all of the G&A costs. Rest of the business now is firmly cash flow positive. It has been for the last couple of quarters, and it will be for full year 2026. Yeah, our focus now to get the company overall to cash flow breakeven, and we've set a target by the end of 2027, is to drive lower cash burn and drive screening towards profitability. I think what's going to get us there is once we get to scale on the commercial side. The quicker we can do that, because we've been investing all of our incremental gross profit on the screen side back into the commercial sales and marketing line.
When we get to a level of scale, then we'll start to see that gross profit drop down to the bottom line. Getting there as quickly as possible is going to help. Of course, driving the revenue and the volume growth whilst maintaining strong gross margins is obviously going to help. Yeah, to your point, Tycho, ACS guidelines are going to help because we see that can be an accelerator on our volume as well as all of the things that we're doing.
Maybe speaking of accelerators on volume, shifting over to G360, the new liquid assay FDA approval, how do we think about any incremental volume uptick in the near term? I think you said that wasn't contemplated in guidance.
Yeah, that wasn't contemplated in guidance. I think, again, with the FDA approval, this is something that our sales team is incredibly excited about. We think there are a few volume levers to pull out. First of all, on the Guardant360 Liquid side, we've had, you could say, a relatively complicated request ordering form. We've had a Guardant360 CDx, an FDA-approved version of the test, which is the smaller panel. We've also had the LDT version of the test, which is on the larger Smart Platform panel with all of the Smart Apps. For doctors just to understand what they're ordering, often they want an FDA-approved test, but they want all of the Smart Apps bells and whistles, and that's been relatively confusing and maybe just held back a little bit of volume.
Now we've got this FDA-approved, best-in-class test with all of the Smart Apps and the epigenomic data just in one simple-to-order test. I think that can help drive volume with this best-in-class test. We've talked a lot about potential attachment of tissue and how this can help our tissue volume. We've been a bit restricted on oncologists being able to order tissue together with a liquid test, which is in guidelines, for example, for lung. The reason being, with our Smart Platform LDT version of the test, we weren't allowed to bill if tissue is available. Now we have a very simple requisition form. It's an FDA-approved test, no tissue insufficiency clause on that, and the attachment rate for tissue with the liquid, we hope or we expect should be a lot stronger than it was in the past.
We think there's a twofold impact on volume. One on liquid, but then two on the tissue pull-through.
Can you maybe just walk through the process of going from FDA approval to achieving ADLT pricing designation? What are the puts and takes when you're setting a Medicare rate for the first nine months of coverage, and when could we expect to hear more on official timing and pricing?
Yeah. First of all, we set the cash pay price now for the FDA-approved version of the test. It's $8,455. An uptick from the $5,000 where the current rate is, and we see that rate reflecting really the value that we're now providing with this much larger panel. With all of the Smart Apps and an FDA-approved product. That price is in play. To get ADLT status, of course, now this is a new test. It's FDA approved. That enables us to go through that process. There's some admin in the background. We need to pull a specific PLA code for the test. When we've got that, we'll apply for the ADLT. We would expect this to come into play in the first half of 2027.
Just as a comparison, Shield, for example, got approved in August, and the ADLT rate went live on the 1st of April, the following 1st of April. That's the sort of timeline we're expecting, so sometime in the first half of 2027. Yeah, when we get that, then that will lead to an immediate increase in our Medicare rate. Yeah, we're very excited to be able to do that.
How should we think about different payer types, Medicare fee for service, Medicare Advantage, commercial? How does the pricing uplift flow through each, and how should we think about overall capture? Is 60% of list a fair assumption?
Yeah. I think if you look now where we are, our Medicare price for Guardant360 over the last few years has been $5,000. We're sort of realizing across all the mix of Medicare Advantage, commercial, and there's some international volume in there as well, but we're realizing $3,000 approximately, which is 60%. I think, we see a pathway to get to that 60% of $8,455. It's going to take some time. We think it's probably a two-year timeline from when we get ADLT. The steps are, of course, yeah, as I just mentioned, Medicare fee- for- service would go immediately.
What we've seen in the past when we've had a Medicare price increase, where Medicare Advantage payers need to follow that price, it can take up to 12 months for all of that to sort of flow through and for the payers to update the price in the system. That'll take some time. On the commercial side, there'll be some blocking and tackling that we know we need to do. We've got contracts with payers. This is a new test. We'll have to add the new test to those contracts. There's payers with coverage in place. We don't have contracts, they generally pay off the list price, so we expect that might flow through a little bit quicker. I think the other thing is, what we've seen in the past with Guardant360 is when we've had an FDA-approved version and an LDT version.
We've often got paid, or our coverage is wider with the FDA-approved version of the test. We expect that we might have an upside on the commercial coverage with now pretty much all of our volume will be on the FDA-approved version of the test. I think there's multiple things that we need to work on on the commercial side. That, again, that could take sort of 12, 18 months or so to flow through. Yeah, we're pretty confident by the end of 2028, we should be achieving around about $5,000 ASP, which is about 60% of that Medicare rate.
Is there upside from FDA approval, in terms of increasing the attachment on tissue, and what's the attach rate today, and where could it go?
The attach rate today is primarily on the, what's been on the CDx version, the FDA-approved version of the test, which is the minority of the Guardant360 volume. I think just moving over to all of the volume being on an FDA-approved version, if that attachment rate stays the same, and it's relatively low, relatively small, below 10%, that should have an uplift. I think just the ability to order that, together with liquid, we'd expect that attachment rate to go up. I don't think we want to sit here and put a specific number on that, but we know the demand's out there. Our sales reps have heard from a lot of oncologists that if they could order what we consider now a best-in-class tissue test together with a best-in-class liquid test from Guardant, they would want to do that.
They've not been able to do that in the past. Yeah, our expectation is that that attachment rate over time can improve significantly.
How about tests per patient? 1.3 today for G360, I guess. How does that expand over time? What are the levers to drive adoption? Is Reveal for therapy monitoring ruled out?
Yeah, as well as the tissue attachment that we just talked about. Yeah, we're really excited about Reveal therapy monitoring. This is very complementary to Guardant360. When an oncologist orders Guardant360, then they can put the patient on Reveal therapy monitoring and monitoring them over time. Let's just say every two or three months, running a Guardant Reveal, see how the therapy is working. If at any point in time the therapy isn't working, then immediately reflex to a Guardant360 with the same blood sample from Reveal, run that, and then identify a potential new therapy for their oncologist to put the patient on. We launched that in Q4. We've seen really strong uptake of that. Of course, the key for us is to get reimbursement from MolDX. We're in the process for both chemo and IO.
When that's in place, we see that can be a real potential driver. From a revenue perspective, but also from this increasing the 1.3 tests per patient, we think that can go significantly higher.
I guess, SERENA-6 was viewed as an upside enabler of expanded G360 tests. How are you thinking about that paradigm after the AdCom and is Reveal for therapy monitoring effectively an offset for potentially the lost upside from SERENA-6?
Yeah, certainly the SERENA-6 at ODAC AdCom meeting was a little bit frustrating. At least the outcome of the meeting was frustrating for us. We thought a lot of the commentary was very encouraging for the paradigm of using ctDNA as an important surrogate marker in these types of studies. We're still in the game where there's potential for FDA approval still based on the empirical data. We're not counting on anything. We look forward to that final outcome. More recently, we have been slightly more encouraged by the request for more information and the data that we saw from AACR yesterday showing very strong ctDNA clearance further boding well for the promise of ctDNA in the future in this area. Yeah, we look forward to the future.
On Reveal, Mike, you mentioned MolDX coverage for IO and breast. What's the latest on timing there and how much is baked into guidance this year for the indications?
We've got applications out to MolDX on breast for MRD and then for IO and chemo in therapy monitoring. We would hope that all of those can be in the relatively near future. We're on this cycle of 60-day reviews and getting questions back and answering them. We've been in that cycle for quite a while, particularly for breast. Hopefully they come soon. It's hard to sit here and put a specific timeline on them. We would hope that they would come soon.
ASPs on Reveal $600, $700, LRP $1,000 by 2028. What has to go right to get to that reimbursement level?
Really it's this MolDX coverage on all of the three indications that I just mentioned, that I think they're really the key to move us getting towards that $1,000. Just to put it in perspective, with Reveal CRC, which now we have MolDX reimbursement in the adjuvant and the surveillance setting, good MA coverage, and our commercial coverage is improving. The ASP on CRC alone is trending very near to $1,000. We've sort of proven it out that if we get MolDX reimbursement, we can be getting on an indication-by-indication basis close to $1,000. I think, again, MolDX reimbursement for those other indications is going to unlock that. It won't be immediate, but I think that'll put us firmly on the path to this $1,000 by 2028.
Launching tumor-informed Reveal later this year, I guess, how should we think about go-to-market strategy, commercial investments that are needed, any cannibalization of tumor-naive?
I think from a commercial investment, we've already made all of that investment with respect to the commercial sales force that we have out there, sort of the brand strength of both Guardant and Reveal on the liquid side. I don't think there's a lot of incremental commercial investment there. I think where we position this and where we're really excited about is that we've got a best-in-class tissue-free option with Reveal. We think about Reveal Ultra with one part per million sensitivity being a best-in-class tumor-informed test, we think being able to just offer that optionality to the oncologist to have both best-in-class from both tissue-informed and tissue-free is going to be a very powerful offering. We're excited to launch that. Again, I think data's going to be key on Reveal Ultra. Reimbursement's going to be key on Reveal Ultra.
We want to get there as fast as we can to really maximize the opportunity. Again, we're excited, and we're planning to launch Reveal Ultra later this year.
Maybe, [Z], I'll give you the last one on AI, ML as a potential driver of revenues. Should we think about this as enhancing existing assays, a broader data product for biopharma? How do you think about it on the revenue side, and then anything on the cost side? Could this accelerate the path to profitability?
Yeah, thanks. AI is a massive tailwind for our business. You're actually on the clinical side already seeing it manifest in new products, kind of acceleration of the launch of new products and new product features across the clinical portfolio. You've seen that in G360 and tissue through multiple upgrades. Yeah, you're seeing that also play out in the biopharma side of the business as well. How does that work in practice? We've built this massive database or data repository of over 1 million patients worth of genomic data in the last 10 years. We've also layered on the epigenomic tech stack across over 500,000 patients worth. Now we have Shield, asymptomatic patient data coming into that database, as well as multiple time points, longitudinal data. This is a very rich data source and extremely valuable pool of information. These are blood-based samples.
These are very rare. What AI is doing is effectively increasing our ability or accelerating our ability to query this database and test hypotheses and to come up with new biological insights and signatures that then lead to actionable new features across the portfolio. Really exciting times. To the second part of the question, Mike can speak to it, too, every part of the organization is leveraging it in ways to improve efficiencies and take costs out of the system. I think the key point is our competitors have a lot of these tools, too, but what they don't have, again, is this data treasury built over a decade of very unique data, very hard-to-replicate data, and that's really the secret to our ability to leverage AI.
Great. We'll leave it at that.