Thanks. We're going to kick it off. I'm Tycho Peterson for the Life Science team. It's my pleasure to introduce Garden. We've got Mike and Zarek 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, you know, impressive relative to the street on screening and oncology. Just talk about some of the momentum you have coming out of the core.
Yeah, thanks. Thanks, Tycho. Yeah, and Q1 was a great start to 2026 for us. You know, our overall revenue growth was 48% a 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. And, you know, we tripped the sort of trailing 12-months, billion-dollar revenue run rate. So I think all bodes well for us there. You know, we saw broad-based strength in Q1. Oncology was very strong. You know, the volume growth was 47%. That's the best we've seen in the last three years. And, again, that was broad-based. Garton 360 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%. So we've seen a lot of traction on Reveal in MRD and also with therapy monitoring. And then, yeah, on screening, a very good start to the year, 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're starting now are really starting to play into the numbers. So we were really pleased with the start, and yeah, it sets us up well for the rest of the year.
And 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 you know, with the smart apps continuing to really drive volume on the liquid side. Again, you know, 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. And again, you know, 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. You know, a couple of things that we said weren't included in our guide and have since come to sort of fruition in the last couple of weeks was the FDA approval for Garden 360 Liquid and then the ACS guidelines. So both of those hit just in the last couple of weeks. They weren't in our guide. So, you know, we start here with even more confidence in the numbers we put out.
And on screening, it's great to, you know, finally get the ACS guidelines, you know, going through last week. Just talk about how you think about uplift there on, you know, volumes this year and next, and what does timelines, you know, now look like for commercial coverage?
Yeah, I think on the ACS guidelines, I mean, first of all, we, you know, really pleased with the guidelines. I think the way that they're written with respect to, you know, for those patients who don't want to do a colonoscopy or a stool-based test, it effectively mirrors the way that we've, you know, the sales team has been selling S.H.I.E.L.D. And it's really how we've positioned that, which is, you know, there's a 50 million unscreened population out there. We've been going into doctors and really, you know, targeting those patients that, yeah, don't want to do any other modalities or in the past those modalities have been ordered and the patient hasn't followed through with them. And so we think those guidelines just back up how we're selling that and they give us a lot of, you know, additional validity around the test. So 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. And so in those states in particular, I think two things. One, you know, 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. So we can open that up. That can be a volume driver. And then, of course, you know, 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 know, we expect it's going to take, you know, 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, you know, denials. But as we sort of speak to them and work with the commercial payers, we'll show that they're going to be updating their coverage policies. So, you know, we see ACS having a positive impact on volume for the remainder of 26 and then probably more of a revenue impact from those ACS states in 27.
And how about the $700 ASP in your long-range plan, you know, that you put out for 2028? Does the guideline update change the thinking there at all?
It doesn't change the thinking on the 28. I think the dynamics that we expect to see on ASP. So we'll open up to those under 65s in the ACS states. We know initially we'll be getting a number of zeros ahead of when we start to get paid. So we expected 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 26. So our guidance for the remainder of 26 is, on average, $775. So that anticipates, you know, we'll be getting some zeros. But 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 on our base case assumption is sort of end 27, start at 28. Again, we'll open up to more commercial volume. initially that'll be sort of zero paid but then the payers will start to pay us and that'll tick back up so we look at 700 as being sort of a low watermark but as the commercial payments ramp up we you know we're it'll it'll be ticking back up and we think you know longer term it'll be at least
over 800 and and you just mentioned uspscf what's kind of longer term view there we haven't seen the draft guidelines you've got you know leadership uh changing hands are you still constructive on the Idea Shield can get USPSTF inclusion?
Yeah, we're still constructive. You know, we see all the noise that's happening around this, and, you know, that group's been disbanded. You know, we're hopeful that it gets put back together in the near future and that it can start its work. You know, we have a very active team in D.C. You know, I think the signals we're getting and that we're hopeful for is that, you know, that group will be put together soon and start its work. And hopefully, you know, one of the key things that they're going to focus on will be updates to CRC. So, yeah, we're still hopeful of, you know, getting there by late 27, 28. Of course, it's out of our hands. But, you know, the signals we're getting, you know, potentially this could move at some point in the near future.
And then just thinking about multi-cancer, you know, how's opt-in fared in the early days here? Is it driven a tailwind on volumes, or is it more about, you know, supplementary features for real-world data?
Yeah, multi-cancer has been great. I don't know, Zarek, if you want to...
Thanks, Tycho. Yeah, 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 kind of the last two quarters. Feedback's been great and 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. But yeah, we think we're really well positioned to be the winner in
multi-cancer over time. And how do you think about MCD monetization, given the current offerings 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 kind of this first step, which is the MCD bill, which creates kind of the first phase for reimbursement for MCD. We're going to continue to kind of work to improve that over time. And, you know, in parallel, yeah, we're running, you know, 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, you know, rising competition in CRC and, you know, MCD overall. As we think about kind of more, you know, entrance into the market, is there a need for Shield 3.0, you know, at some point?
We don't think there's a need for Shield 3.0. You know, I would say the team is, you know, always continues to look at improving the test. So, you know, we're continually working at that. But, you know, as Zarek mentioned, you know, we've got a differentiator with multi-cancer. We're, of course, working on lung. You know, that study is ongoing, but we would expect a readout on lung at some point in 2027. So I think, you know, there's a lot that we're doing on the development side to continue to progress Shield. On the commercial side, you know, 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, you know, all of the things that we've been doing over the last almost two years now in building out a very significant commercial infrastructure. you know we ended the 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 you know we think that's given us a massive step up in connectivity just on the on the EMR system and you know very importantly and sort of these 8,000 blood draw centers request so you know that's that's creating a very significant moat for us. I think the DTC initiative that we kicked off in Q1 on top of the HPC 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 you know the doctors have already heard of shield either from the HPC marketing that we're doing or you know patients coming in and I've seen the I've seen shield tests now with a DTC so I think you know 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 you know change your view on just the
commercial footprint you need um no i think you know again we we've always we've always sort of um had this assumption on on competition and i think we've had our you know eyes and ears out for a long time understanding how the market's going to develop you know we've always said you know at scale um by 2028 you know 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, but 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%, so yeah, over 90% of 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 and so that is that's that strong adherence is a good 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 so yeah we think that 600 and 700 is a good target for us to set for 2028
and just maybe last one and chill the um it's been kind of a gaining factor on reaching cash flow break even obviously at a corporate level you're talking about you know the end of 27 4q um anything to change that kind of trajectory like do the guidelines maybe pull that forward
or not yeah i think um i mean first first of all on cash flow break even i would say you know and we are pains to point this out excluding screening the rest of the business and that's that's loaded with pretty much all of the gna costs rest of the business now is uh is firmly cash flow positive it will be for it has been for the last couple of quarters and it will be for full year 26 so yeah i will focus now to get the company to uh overall to cash flow breakeven and we've set a target by the end of by the end of 2027 is to drive um you know lower cash burn and drive screen towards profitability I think what's what's going to get us there is once we get to scale on the on the commercial side so 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 drop down to the bottom line so getting there as quickly as possible is going to help and and of course driving the revenue and the volume growth whilst maintaining strong gross margins is obviously going to help. So, 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.
And maybe speaking of accelerators on volume, shifting over to G360, you know, the new liquid assay FDA approval, how do we think about any incremental volume, you know, 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 you know with the FDA approval this is something that our sales team is incredibly excited about you know we think there are a few volume levers to pull that you know first of all on the garden 360 liquid side you know we've had you know you could call that a relatively complicated request ordering form we've had a garden 360 CDX and 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 and so for doctors just to understand what they're ordering often they want an FDA approved test but they want all of those 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 the smart apps and the epigenomic data just in one simple to order test I think that can help drive drive volume with this best-in-class test you know secondly we've talked a lot about you know potential attachment of tissue and how this can help our tissue volume again we've been a bit restricted on oncologists been able to order tissue together with a with a liquid test where you know which is in which is in guidelines, for example, for lung. And the reason being with our smart platform LDT version of the test, we weren't allowed to bill if tissue is available. And 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. So we think there's a, yeah, two-fold impact on volume, one on liquid, but then two on the tissue pull-through.
And can you maybe just walk through the process of, you know, 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, you know, official timing and pricing?
Yeah, so, I mean, first of all, we set the cash pay price now for the FDA-approved version of the test. It's $8,455, so 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. So that price is in play. To get ADLT status, of course, now this is a new test. safety approved that enables us to 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 then we'll apply for the ADLT so you know we would expect this to come into play in the first half of of 2027 just as a But a comparison, S.H.I.E.L.D., for example, got approved in August and the ADLT rate went live on the 1st of April, the following 1st of April. So that's the sort of timeline we're expecting. So sometime in the first half of 27. And, yeah, when we get that, then, you know, that will lead to an immediate increase in our in our Medicare rate. So, yeah, we're very excited to be able to do that.
And how should we think about, you know, different payer types, you know, 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 this, you know, fair assumption?
Yeah, you know, I think if you look now where we are, our Medicare price for Gardner 360 over the last few years has been, you know, $5,000. We're sort of realizing across all the mix of Medicare, Medicare Advantage, commercial, and there's some international volume in there as well. But we're realizing, you know, $3,000 approximately, which is 60%. So I think, you know, we see a pathway to get to that 60% of $84,55. It's going to take some time. You know, we think probably 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. So that'll take some time. And then 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. When 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 GARNA 360 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 tests. So, you know, 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. So I think there's multiple things that we need to work on on the commercial side. And that, you know, again, that could take sort of 12, 18 months or so to flow through. But, yeah, we're pretty confident that by the end of 28, you know, 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 what's been on the CDX version, the FDA-approved version of the test, which is the minority of the Gardner 360 volume. so I think just moving over to all of the volume being on an FTA approved version that should that should that if that attachment rate stays the same and it's relatively low relatively small below 10% that should have an uplift and then I think just the ability to order that together with with liquid we'd expect that attachment rate to go but I don't think we want to sit here and put a specific number on that but we know we know the demands out there you know our sales reps have heard from a lot of oncologists that if they could order, you know, what we consider now a best-in-class tissue test, together with best-in-class liquid test from garden, they would want to do that. They've not been able to do that in the past. So, yeah, our expectation is that that attachment rate over time can improve significantly.
How about test per patient? You know, 1.3, you know, today for G360, I guess, you know, how does that expand over time? What are the levers to drive adoption, you know, as Reveal for therapy monitoring rules out?
Yeah, I mean, as well as the tissue attachment that we just talked about. Yeah, we're really excited about Reveal therapy monitoring. You know, this is very complementary to Garden360. When an oncologist orders Garden360, then they can put the patient on Reveal therapy monitoring and monitor them over time. So, you know, let's just say every two or three months, running a Gardent Reveal see how the therapy is working and then if at any point in time the therapy isn't working then immediately reflex to a Gardent 360 with the same blood sample from Reveal run that and then identify a new potential new therapy for their oncologist to put the patient on and so we launched that in Q4 we've seen really strong uptake of that Of course, the key for us is to get reimbursement from Molde-X. We're in the process for both chemo and IO. But when that's in place, we see that can be a real potential driver. So from a revenue perspective, but also from this increasing the 1.3 tests per patient, we think that can go significantly higher.
And I guess Serena 6 was viewed as an upside enabler of expanded G360 tests. I mean, how are you thinking about that paradigm after the ADCOM and is revealed for therapy monitoring effectively an offset for, you know, potentially the lost upside from Serena 6?
Yeah, certainly, you know, the Serena 6 ODAC ADCOM meeting was a little bit frustrating, at least the outcome of the meeting was frustrating for us. We thought that, you know, 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. There's potential for FDA approval still, based on the empirical data. But we're not counting on anything. We look forward to that final outcome. More recently, we have been slightly more encouraged by, you know, the request for more information and the data that we saw from ASTRA yesterday showing very strong ctDNA clearance, kind of further, you know, boding well for the promise of ctDNA in the future, you know, in this area. So, yeah, we look forward to the future.
And then on reveal, Mike, you mentioned, you know, mold X coverage for IO and breast. What's the latest on timing there and how much, you know, is kind of baked into guidance this year for the indications?
Yeah, you know, we've got applications out to Moldyx on breast for MRD, and then, yeah, for IO and chemo in therapy monitoring. We would hope that, you know, all of those can be in the relatively near future. You know, we're on this cycle of 60-day reviews and getting questions back and answering them. And we've been in that cycle for quite a while, particularly for for for breasts so yeah hopefully they come soon it's hard to sit here and and put a time a specific timeline on them but we would we would hope that they would come uh come soon
and then asps you know on reveal six seven hundred dollars lrp a thousand you know by 28 you know what has to go right to get to that that reimbursement level um really it's it's uh this
multi-ex coverage on on all of the three indications that i just mentioned that i think they're really the key uh to move us getting towards that thousand just to put in perspective but with reveal crc uh which now we have multi-ex reimbursement in the adjuvant and the surveillance setting uh good ma uh coverage and our commercial coverage is improving the asp on crc alone is it's trending very near to a thousand dollars so we've sort of proven it out that if we get moldyx reimbursement we can be we can be getting on an indication by indication basis you know close to a thousand um so i think i think um again moldyx 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
you know thousand dollars by 2028 and then you know launching tumor informed uh reveal ultra later this year, I guess, how should we think about go-to-market strategy, commercial investments that are needed, any cannibalization of, you know, tumor-naive? Yeah, I think, you know, from a
commercial investment, I think, you know, 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 garden and and reveal on the liquid side so I don't think there's a lot of incremental commercial investment there I think where we where we where we position this and where we really excited about is that you know we've got a best-in-class tissue-free option with reveal we think about reveal ultra with you know one pop a million sensitivity being a best-in-class tumor informed test and so we think we know to just offer that optionality to the oncology to have both best-in-class from both tissue-informed and tissue-free is going to be a very, very powerful offering. So we're excited to launch that. Again, I think, you know, data is going to be key on Reveal Ultra. Reimbursement is going to be key on Reveal Ultra. We want to get there as fast as we can to really maximize the opportunity. But, again, you know, we're excited, and we're planning to launch Reveal Ultra later this year.
Maybe, Zee, I'll give you the last one on AI, ML, you know, as a potential driver of revenues. Should we think about this as, you know, enhancing existing assays, a broader, you know, 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 of profitability?
Yeah, thanks. AI is a massive tailwind for our business. You're actually, you know, 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. And, yeah, you're seeing that also play out in the biopharma side of the business as well. And, you know, how does that work in practice? is, you know, we've built this massive database or data repository of over a million patients worth of genomic data in the last 10 years. We've also layered on the epigenomic tech stack, you know, across over 500,000 patients worth. Now we have shield, you know, asymptomatic patient data coming into that database, as well as kind of multiple time points, kind of longitudinal data and so this is a very rich data source and extremely valuable pool of information and these are blood-based samples these are very rare and so we're you know what AI is doing is effectively increasing our ability or accelerating our ability to kind of query this database and test hypotheses and to come up with kind of new biological insights and signatures that then lead to, you know, actionable new features on, you know, across the portfolio. So really exciting times. And then, you know, to the second part of the question, I mean, it's, and Mike can speak to it too, you know, every part of the organization is leveraging it in ways to, you know, improve efficiencies and take costs out of the system. But I think, like, 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 kind of the secret to our ability to leverage AI.
Great. We'll leave it at that.