GRAIL, Inc. (GRAL) Q1 2026 Earnings Call Transcript

Good day, ladies and gentlemen, and welcome to the GRAIL First Quarter 2026 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. Please be advised that this conference call is being recorded. GRAIL Investor Relations, please begin.

Thank you, and thank you all for joining us today. On the call are Bob Ragusa, our Chief Executive Officer, Aaron Frieden, our Chief Financial Officer, Josh Hoffman, President, Sir Halper Kumar, Chief Scientific Officer and President International, and Andy Partridge, Chief Commercial Officer. I'll remind you that we'll be making forward-looking statements based on current expectations. It's our intent that all statements, other than statements of historical fact, including statements regarding our anticipated financial results and commercial activity, will be covered by the safe harbor provisions for forward-looking statements under federal securities laws. Forward-looking statements are subject to risks and uncertainties. Actual events of results may differ materially from those projected or discussed. All forward-looking statements are based upon currently available information, and GRAIL assumes no obligation to update these statements. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that GRAIL files with the SEC, including the risk factor section on GRAIL's most recent annual report on Form 10-K and the quarterly report on Form 10-Q, which we plan to file for the first quarter of 2026. This call will also include a discussion of gap results and certain non-gap financial measures, including adjusted gross profit and adjusted EBITDA, which excludes certain specified items. Our non-gap financial measures are intended to supplement your understanding of gross financials. Reconciliations of the non-gap measures to most directly comparable gap financial measures are available in the press release issue today, which is posted to our website. And with that, we turn to Bob.

Good afternoon, everyone, and thank you for joining us to review first quarter results. I will take a moment to highlight recent achievements before turning it over to Josh for an update on our clinical programs and recent and upcoming data, then over to Aaron to cover financials. This quarter, we saw continued strong commercial momentum with expanding physician adoption, increasing engagement across health systems, and growth in test volumes. Rails sold over 56,000 gallery tests in the first quarter, a 50% increase in volume year-over-year. Total gallery screening revenue was $39.8 million, up 37% over the prior year. We are making important strides to enhance provider and patient awareness of MSED. We continue to grow our partnerships with health systems, which educate physicians and engage the community. We are seeing growing deployment of gallery and leading systems, including Dana-Farber, Rush, OHSU, and Cleveland Clinic and Duke. We are seeing major health systems, including Community Health and Intermountain, investing in new and expanded employee benefit coverage of Gallery. We are continuing to deepen our work with existing digital health partners, which enable outreach to curated memberships. We have also recently added additional partners, such as Whoop. Also, our employee relationships continue to expand as experience with Gallery grows. We've invested in the ease of access through our previously announced partnerships with Quest to integrate into their ordering systems in our recently announced collaboration with the EPIC electronic health record platform. Integration through EPIC Aura will allow health systems and their HCPs to order the gallery tests directly at the point of care, receive structured results, and manage patient follow-up within their existing native EHR and with their existing clinical workflows. Integration will provide standardized implementation and quicker onboarding for health systems adopting gallery. Integrations are beginning now. In January, we announced that we completed our FDA PMA submission, which has been accepted by the FDA for review. The PMA for gallery is focused on test performance and safety results from the first approximately 25,000 participants in the Pathfinder 2 study with one-year follow-up and the prevalence screening round only of the NHS gallery trial. The submission also includes a bridging analysis to compare performance of the version gallery used in the clinical trials to the updated version that has been submitted to the FDA for pre-market approval. We announced in February our planned expansion of the field sales and medical teams. We expect the majority of the new sales personnel will be onboarded and trained by mid-year. We believe this expansion will enable us to continue to drive commercial momentum. Finally, we are looking forward to the upcoming data presentations for our 140,000-participant NHS gallery trial and the 35,000-participant Pathfinder 2 study at the 2026 American Society of Clinical Oncology annual meeting later this month. We're excited to share data from the studies and begin to incorporate the learnings in our educational and sales initiatives. Following our data presentations at ASCO, we are planning to hold an analyst call on Sunday evening, May 31st. Stay tuned for details on the analyst call in the coming weeks. And with that, I'll ask Josh to provide an update on our clinical programs.

Thanks, Bob. At GRAIL, we're very excited about the comprehensive data we've been generating to demonstrate the value proposition for GALLERY. This technology has been validated through robust studies, including those in intended use populations. More than 174,000 individuals are included in studies supporting our PMA submission to the FDA, and we're seeing consistent results through hundreds of thousands of commercial and clinical study tests. Through our studies and commercial testing, we've built what we believe is the largest linked clinical and genomic data set in the field. We have already been able to use these data to drive test improvements, and we'll continue to do that over time. Our teams have continued to present evidence demonstrating Galleries' performance at renowned medical conferences, including two new analyses at the American Association of Cancer Research annual meeting in April. The first assessed the association between emergency department involvement in the diagnosis of cancer and overall survival across different cancer types in the Medicare population. Emergency department involvement was associated with a significant fraction of overall mortality in patients with cancer. Emergency department involvement in diagnosis remained a strong, independent predictor of mortality after adjusting for sociodemographics, comorbidities, and stage of diagnosis. A second study evaluated adherence to mammography screening before and after MSED testing. Women who received a negative MSED result maintained their high adherence to guideline-recommended mammography, with greater than 80% undergoing screening in the 24 months after MSED testing. Similar rates in the 24 months before testing. As a reminder, gallery is intended to be used alongside existing standard-of-care single cancer screening tests, and these findings suggest that MSID testing will not negatively impact participation in guideline-recommended cancer screening. Earlier this year, we released top-line data from the NHS Gallery trial, which is the first randomized trial to demonstrate population-scale stage shift for a multi-cancer early detection test. Working with the NHS, we agreed to a combined endpoint of stage 3 and 4 reduction over three rounds of screening. What was observed in the trial was an increase in stage 3 cancers detected and a decrease in stage 4 cancers detected, which ended up canceling one another out in this combined endpoint. While we did not achieve a statistically significant reduction in this combined primary endpoint, we did demonstrate a number of strong clinical utility findings. We observed an increase in the detection of stage 1 and 2 deadly cancers and a four-fold higher cancer detection rate compared to standard-of-care screening alone. These findings indicate we were able to find deadly cancers that we are not screening for, and also find cancers that we've been missing with standard-of-care screening. We also observed meaningful reductions in stage 4 cancer diagnoses and in the emergency presentation of cancer. These findings suggest that with multiple rounds of screening, we may be able to identify some of the most lethal cancers earlier. Reducing stage 4 diagnoses is incredibly meaningful because there is a large survival cliff between stage 3 and stage 4 for many types of cancer. Many stage 3 cancers can now be treated with curative intent, and finding these cancers at stage 3 rather than stage 4 can make a meaningful difference in a patient's treatment experience and outcomes. The reduction in emergency presentation reflects a similar opportunity to improve the patient experience, their care, and their outcomes. Cancers presenting in the emergency room represent 20% of cancer diagnosis in the UK and similar numbers in the US, and these cases are among the costliest and those associated with some of the poorest outcomes. We believe that both the increase in overall and in early cancer detection and the decrease in metastatic and emergency presentation of cancer are important and relevant to providers and payers in evaluating the clinical and economic value of gallery as a complement to standard of care screening. We're really looking forward to presenting these data, plus the results from all 35,000 participants from our Pathfinder 2 study at ASCO in just a few weeks. I'll hand off now to Aaron for review of our financials.

Thanks, Josh, and good afternoon, everyone, and please present our results for the first quarter. First quarter results were strong, with revenue of $40.8 million, up $8.9 million, or 28%, as compared to the first quarter of 2025. Total revenue for the quarter consisted of $39.8 million of screening revenue and $1 million of development service revenue. Screening revenues was up 37% as compared with the first quarter of 2025, with test volumes of more than 56,000 tests, an increase of 50% over Q1 of last year. Net loss for the quarter was $93.2 million, an improvement of 12% as compared to the first quarter of 2025. Non-GAAP adjusted gross profit for the first quarter of 2026 was $19.7 million, an increase of $5.4 million, or 38%, as compared with the first quarter of 2025. Primary drivers of the increased gross margin were improved fixed cost leverage due to the increase in volumes and a decrease in sample reprocessing costs, partially offset by a decrease in ASP. Adjusted EBITDA for the first quarter of 2026 was negative $79.9 million, representing an improvement of $18.8 million, or 19%, as compared to the first quarter of 2025. We ended the quarter with a cash position of $823.1 million, providing us with the financial flexibility to navigate growth over the next several years as we pursue key milestones toward broad access to our multi-cancer early detection technology. Back to you, Josh.

Thanks, Aaron. Bob, before your retirement at the end of this month, I want to take a moment to acknowledge the tremendous contributions you've made as CEO of Grail. All of us at GREL and everyone joining today's call who follows our story can appreciate the incredible progress you've led our teams through over the last five years. Our spin-out from Illumina, our commercial expansion, and the scaling of our North Carolina laboratory operations. As a result, GREL has a strong operational and financial foundation to advance multi-cancer early detection at scale and is well-positioned for long-term growth. Bob, on behalf of all of our teams at GRAIL, thank you.

Thanks very much, Josh. Leading GRAIL and working alongside this extraordinary team has been the greatest honor of my four decades in healthcare. We are addressing one of the most urgent healthcare challenges of our time, and I am extremely proud of our pioneering work. I'd also like to express my sincere thanks to each Grail employee. Every achievement we've made has been a result of the ideas and actions spurred by the great people across this company and driven by a commitment to a singular goal. Our vision is population scale, multi-cancer early detection, and we're making real advances each year. I'm pleased to pass the reign shortly to Josh, who's played a central role in driving Grail's strategy and execution over the past seven years. Operator, we can go to Q&A.

Thank you. At this time, if you would like to ask a question, please click on the raise hand button, which can be found on the black bar at the bottom of your screen. You may remove yourself from the queue at any time by lowering your hand. When it is your turn, you will hear your name called and receive a prompt to unmute. As a reminder, we are allowing analysts one question and one relevant follow-up today. We will wait one moment to allow the queue to form. Thank you. Our first question will come from Subu Nambi with Guggenheim. Your line is open. Please ask your question.

Thank you for taking my question and great print. The FDA and CMS recently established the Rapid Pathway in which CMS will propose the NCD for Class 3 breakthrough devices on the same day that the FDA provides market authorization. Given Gallery has the breakthrough device status and would be expected to be a Class 3 device, do you expect Gallery to be eligible for the Rapid Pathway or does the 2029 start date specified in the MSET bill negate this opportunity? Sorry for the long question.

Thanks, Abu, for the question. You know, we've looked at RAPID, and right now it's kind of just a framework without a lot of detail, but, you know, on a high level, it does look like, you know, the characteristics of our tests, you know, the breakthrough designation, the fact that we're driving for FDA approval does put us, you know, in what the act is intended for. So we're hopeful that when the details come out, we will find ourselves being very much eligible for that. But we do have to wait to see how the details unfold for that particular piece of legislation. Josh, any other comments on that?

No, I mean, it's an important piece of regulation, and it's very encouraging. I mean, I think for years now, the government has been trying to shorten the gap between FDA approval and CMS coverage. This is something the administration has been prioritizing. It's great to see. And I think to Bob's earlier point, everything that we've done from seeking FDA approval, having a breakthrough device designation, conducting an IDE that was reviewed by the FDA and CMS should comport with what this regulation is intending to do. So we're looking forward to seeing the details and the regulation itself.

Um, perfect. And, uh, how much growth from partnerships like Function Health and Hints and Hours are factored in your guidance for gallery growth in 2026? And then maybe I missed this, but, uh, given the beat, are you raising guidance? I'm hopping through multiple learnings, so pardon my question here.

Aaron, you want to? Yeah. So your first question, Subu, nice to talk to you. So we've got our guidance, which we're reiterating, still the same guidance, not updating it. You've got a 10% range there. One of the reasons for that is to really learn and see how the uptake works in the digital health space. Some of those partners, like Function, we've got more experience with, but, you know, with hims and hers and some of these other new agreements that we've signed, you know, as they implement, we'll see what uptake is like. You know, depending on how they implement it, it can go quickly. Sometimes it doesn't.

Got it. Thank you so much, guys. Your next question will come from Kyle Mixon with Canaccord Genuity. Please unmute your audio and ask your question.

Hey, guys. Thanks for the questions. Yeah, congrats to the quarter. First one, just a bigger picture question. It's been a few months since the NHS Gallery reveal. Can you talk about the feedback from stakeholders since then? And then, you know, very exciting to have the ASCO presentations pretty soon here. Do you expect a material change in opinions following those abstracts and perhaps the call with the investors as well?

Sure. So first piece on the NHS, you know, so we obviously, you know, we had a strong quarter, you know, we were able to grow volumes by 50% and revenues by 37% in the screening, you know, screening part of the business. So, you know, we clearly saw current strength. Andy, maybe, you know, jump over to you to talk about, you know, customer response to the NHS gallery.

Yeah, thanks, Bob. Thanks for the question. As Bob said, we've seen strong growth through Q1, kind of year over year, and that growth's been across brick and mortar providers, digital health, and employers. Drilling specifically into healthcare providers, we've seen a significant expansion of new ordering healthcare providers in Q1 with about 1,300 new prescribers to gallery that we saw in the quarter. We've also added important new customers across our employer business, health systems, as Bob mentioned, Cleveland Clinic, Duke, OHSU, all kind of came on board to incorporate gallery with agreements in Q1, and also added new digital health customers in Q1. All of this in the midst of the NHS Gallery data being released. I think specifically to the NHS gallery data, that media coverage and some of the negative media coverage that was generated has led to questions from customers, healthcare providers, employers, and also from patients. As the data from the study has not yet been presented, it's been difficult for our teams to answer every single patient or provider question related to the study. Therefore, once the data comes out at ASCO, there's definitely going to be interest from customers for us to walk them through that detailed data, and we've got plans to train all of our sales force immediately after ASCO on that data so they can follow up with customers. As Aaron highlighted, we're confident in our growth prospects, and indeed, we're finalizing our sales force expansion efforts.

Yeah, wow, that was great. Thanks, guys, so much. I guess my final question or second question is going to be about expansion opportunities, kind of in the near term here. So you've got the Epic EHR integration. I think planning for that began when that was basically announced in April or so. I know you have the Quest portal, you have Athena. Like, based on your experience with those platforms in the last year or so, you know, can you just talk about your enthusiasm of what Epic could do for you and then, you know, expansion plans to Oracle, certainly? And then just on the Salesforce expansion as well, I mean, are you looking at like pretty healthy tailwinds in second half due to things like Epic and the Salesforce expansion as well?

Yeah, so if you think about, maybe over the first part, you know, the Epic expansion, that's something we've been looking to do for a period of time. So we're really excited about announcing that. We know that, you know, that is, you know, a huge part of the kind of easy button within health systems, be able to have, you know, the gallery test within their normal workflow, both from the ordering side, as well as the test results coming in. And so it really just fits into the entire workflow of a physician. So it makes it much, much more likely to be able to be integrated into a health system. So, you know, that implementation is starting now, and really in the second half of the year, we'll start to see some integrations into actual health systems there. So you'll look for that to build over the second half of the year. You know, Andy, maybe some discussion on the Quest side, what we're seeing there, as well as the Salesforce expansion.

Sure. So with both Quest and Athena, we're seeing continued adoption of electronic ordering with Athena and Quest. Indeed, we've got about 2,000 healthcare providers now who have ordered through either the Quest or Athena integration, which has led to over 30,000 tests being deployed through either the Quest or Athena integration since we launched both of those integrations. So we're very excited about the continued... Use of Questa and Athena by our customers, as Bob said, it really does provide that easy button for them. And with Epic now launching on top of that, it provides another kind of easy button for, as we announced in our press release, 450 health systems. And those are the big health systems across the US. And essentially, any health system that was on the EPIC system in November 2020 or later is going to be eligible for our EPIC Aura integration. And then in terms of the sales force. We're going to have completed that expansion by the middle of the year, and then with the ASCO data coming out for both NHS Gallery and Pathfinder 2, and potentially an FDA approval at some point, yep. Later this year or early next year, that's going to give the sales force a lot of wind at their back to continue the momentum that we've seen with Gallery that we're reporting today.

Okay. Yeah, very helpful, guys. Appreciate it.

Your next question will come from Dan Brennan with TD Cohen. Your line is open. Please ask your question.

Great. Thank you. Thanks for the question. Maybe just starting off, I know there's a question already about the feedback so far since the NHS gallery data are out, but maybe can you just share a little bit more on that? We'll learn, obviously, a lot more at ASCO, but I'm just wondering. With that 20% plus stage four shift, kind of what the feedback's been from oncologists, and any particular cancers or oncologists or experts are feeling most optimistic about that shift?

So, you know, with respect to the reduction in stage four, the 20% plus reduction in stage four in particular, you know, that is one of the things that's really resonating with both primary care physicians as well as with oncologists. And I would say over the last, you know, since that data has been released, we've seen more favorable things from oncologists who truly understand just how important, you know, that reduction is. So, you know, we've, I think over the last five years with gallery being out in the market, we've seen good understanding from primary care physicians and, you know, but the oncologist communities probably lag behind in their understanding because they're not frontline users of it. But I think that particular piece really caught their attention quite well. So I think that that piece in particular is resonating really nicely. No, go ahead.

Okay, great. And then maybe just in terms of, you know, the guidance range for the year, I know there's a couple questions asked about like the buckets and the drivers there, but, you know, could you help like zoom out a little bit and just Give a little bit more color about, you know, between, you know, health systems, concierge medicine, direct the PCP, kind of where are you guys seeing like the most traction right now? And, you know, how do you think about, you know, the rest of the year in terms of the guide? Does it remain in those buckets or does anything change on that front? Thank you.

Yeah, maybe I can give a little bit and then I'll pass it over to Aaron and Andy that gives more color. You know, so the self-pay piece remains the majority of galleries volume, you know, kind of for kind of two thirds plus of the volume, you know, in terms of. Volume growth, you know, the brick and mortar positions continue to be strong. You know, clearly, as we talked about our integrations with Quest and Health, that, you know, helped add new providers and reduce order friction. You know, going forward, we do see the Salesforce expansion continuing to drive extra volume. You know, digital health continues to provide a great opportunity in the self-pay market. You know, here we have access to people who are used to being in the self-pay market, and that's continued to, you know, do quite well with, you know, partners like Function Health and Everly Wells, and then we have, you know, the new partnership coming on with HIMSS and then WHOOP that we just announced. So as Aaron mentioned, we'll have to see, you know, just how fast the uptake of those goes. But I think that gives you some sense. Aaron, any add on the color on the guide?

No, I mean, I think it's Bob's covered it. You know, we'll track to see how the quarters go and look at it again next quarter.

Great. Thank you.

Your next question will come from Katherine Schultz with Baird. Your line is open. Please ask your question.

Hi, thanks for the questions. Maybe first on guidance, I think ASPs step down sequentially. How should we expect those to trend for the rest of the year? Just curious on kind of volume versus ASP assumptions in your reiterated guide and any color on how we should be thinking about second quarter revenue?

Yeah, so maybe I'll hit the ASP piece. So, you know, if you recall, you know, our vision all along has been, you know, to operate gallery at population scale. And, you know, so we have planned for price reductions over time. As we talked about, we made significant investments in our new scalable platform. And, you know, we've rolled that out, you know, throughout from late 24, you know, all the way through 25 into this year. So with that, that gives us the ability to bring pricing down while maintaining strong margins. And so in 2025, we've really began to lean into the price elasticity that we see in the market. And so we're finding success by expanding some of our discounting programs. Much of that happened already in 2025. And so you're seeing kind of a decline as we set up new pricing structures within each of the channels. You know, so within 2026, we would only expect, you know, relatively modest declines to continue other than things driven purely by mix. So it was the mix of the various channels. You know, changes throughout the quarters, you might see price increase or decrease on ASP based on that, but that's really going to be a mix issue, you know, with an overlay of maybe a slight, you know, slight decline in ASP per channel.

Okay, anything on 2Q?

Again, we expect our growth for the year to be between 22% and 32% on the revenue side.

Okay, and the last question for me, we've seen some competitors increasing their DTC advertising. We had one announce a celebrity spokesperson a couple weeks ago, and you've talked about, you know, the Salesforce expansion, but any plans you have on the advertising side to make sure you're getting brand recognition with consumers?

You know, so we have been doing a little bit more, certainly in the social media channels and things to, you know, get the message out. You know, one of the things we've actually found is, you know, the competitors, by competitors, you know, advertising the MSED space, that's actually brought a lot more awareness for MSED. So, you know, we're actually seeing, you know, while it's obviously a competitive, you know, potential competitive threat, we're actually seeing a fair amount of tailwinds from that as people will get, you know, more and more acclimated to, you know, the whole MSET space to get more knowledge about the MSET space. And when, you know, our sales team can go in and describe our product to someone who's now aware and interested, we usually end up doing very well there. So, you know, so far, you know, largely a headwind. Those will continue to and probably increase our marketing spend a little bit to be able to get more message out there through social media and things. But, you know, probably not to the level that some of the other competitors are putting out there.

Thank you. Your next question will come from Doug Schenkel with Wolf Research. Please unmute your audio and ask your question.

Hi, this is Colleen on for Doug. Thanks for the question. A bit of a follow-up from Kyle's question on Salesforce expansion. Can you provide any color on how many reps are currently in the field? Is it fair to assume you're back up to levels prior to the Illumina spin? And then finally on this one, how long do you expect it to take the newly hired reps to get to full productivity?

Andy, you want to take that one?

Yeah, so we're not going to get back to Illumina levels in terms of sales team in the field. The expansion of the sales force is in the provider channel, so we're expanding territories from about 90 territories up to 120 territories. And in terms of productivity of that team, we're going to have the majority of that team onboarded and trained around the middle of the year.

All right, thank you so much. And then just one on the FDA approval process for Gallery. Based on your conversations with the FDA post-final PMA module submission, what's your read on whether the FDA will convene an adcom? Our sense is that, based on the timing, we should be hearing about that soon. And if an adcom is called, what do you think the key areas of focus will be, given the FDA already met at the end of 2023 to discuss MSED?

Josh, can I weigh in on that?

Sure. Good question. As you mentioned, we did submit the final module of our PMA earlier this year, and the FDA had accepted that file. We are in an ongoing, iterative review process right now. And the FDA guidance on timing is typically 180 days from submission without an advisory committee and about 320 days with an advisory committee. We'd be speculating right now about whether there will or won't be an advisory committee, so we can't really comment on that right now, but we've been very active in supporting the FDA's review. Discussions have been very constructive, but it's unknown right now whether the FDA will hold an advisory board, and if they do, what the focus of that advisory board will be. As soon as we learn more, if we can share that, we will, but that's kind of where we are right now. We're in the middle of a very iterative review process.

Your next question will come from David Westenberg with Piper Sandler. Your line is open. Please ask your question.

Thank you very much. I just want to hit on the topic of the 22% to 32% guidance, but you obviously came in at 37%. I know you didn't want to answer the seasonality question, but can you give any additional color to why there might be some of the conservatism? Maybe you saw really good seasonality. Is there channel mix? Is there ASPs that would make it come in below what you came in in Q1?

I'll start and then have Aaron. I think the first part is, you know, it's just early in the year. You know, obviously, this is a pretty important year for us with our FDA filing. You know, we have a number of factors out there. We have the Salesforce expansion. We have ASCO coming up at the end of this month. So there's a number of catalysts out there that we're looking to see how they go. As we mentioned earlier, we have a number of digital health partners that we've signed, but now it's a matter of seeing how fast the uptake can go with them, how aggressive they are in the market, as well as it was also mentioned, just some of the competitive pressures out there. So, you know, in that whole mix, we kept guidance the same, and, you know, as Aaron mentioned, you know, we would update again, you know, look to see if there's anything new to report out at the end, you know, after Q2. I mailed it again.

All right. Then maybe I'm just going to move on to the Epic integration. So you announced Epic integration is going to be expected by the end of the year. How many health systems are you currently in active discussion with? And what's your expectation for winning testing in that other, you know, not DTC channel in the back half of the year? And then can that, you know, flow through for 2027? Can that start to be the bigger channel or am I too early on that?

Yeah, and you want to give some color on that one?

Yeah, in terms of, yeah, epic. There's about 450 health systems that we're targeting for the EPIC integration. As I said earlier, it's essentially any health system that is on the November 2020 or later version of EPIC that's going to be eligible for this integration. And when I say 450 health systems, one health system would be HCA, one health system would be Mayo. So these are big. Big health systems. We're currently in the process of the technical build and go-to-market readiness, building the tests and production environments in AWS, so all that kind of technical work's being done right now. As Bob said earlier, we would actually get customers live on Epic in Q3, and the sales team currently are profiling customers to assess their excitement and conviction around when they want to go live on the Epic platform. So we're currently assessing exactly what that list is going to look like. So I don't have a specific answer for you right now. But I can tell you there is a lot of excitement with our current health system adopters in terms of the Epic Aura integration. And could you repeat the last part of your question? Because I didn't quite catch it.

Oh, I was just thinking about how we should think about mix between hospital and DTC channels in 2027 and beyond.

I think that's too early for us to give any guidance. A lot of that's going to be driven by when we get the FDA approval. So I think it's a little early to comment on that. I think Epic itself is going to give us a tailwind in terms of health system. integrations, but the demand itself, we have to create. A health system needs to want to adopt gallery. Epic, then, is the easy button for them that improves the provider experience by streamlining gallery ordering, resulting, and follow-up. But as I said, our systems are very excited about Epic Order integration with Gallery. That's going to sit alongside our Athena and Quest electronic order integrations as well.

Thank you for taking my questions.

Our last question will come from Bradley Bowers with Mizuho. Please unmute your audio and ask your question. Bradley Bowers with Mizuho, please unmute your line to ask your question.

Sorry about that. I was muted. Thanks. Just wanted to maybe get into something we've talked about a little differently. Just wanted to hear about, I assume it's kind of a pre-ASCO preview, but we're going to get NHS Gallery and Pathfinder full data. It might require some of the slices that we've seen before, performance in deadly cancers or hard to detect or those without a paradigm. So, you know, is this group, you know, of the eventual customers, are they kind of conducive to these slices? You know, do they understand, you know, the superior sensitivity of gallery or specificity? You know, and also that kind of leads into how competitor dynamics have been, you know, we're about six months with other tests on the market.

Joshua?

Yeah, no, it's a great question. I think that it's fair to say that our customers, you know, are fairly well versed in the performance of gallery. You know, gallery performance has been demonstrated in multiple large studies now, from case control studies to interventional studies and intended use, you know, the Pathfinder study, Pathfinder 2, and now they're going to see the full data set from NHS gallery. But as it relates to performance, you know, we think the customers absolutely understand. You know, the very high specificity, the safety profile of gallery, its ability to detect where in the body a cancer signal comes from with very high accuracy, its very strong episode sensitivity in the deadly cancers, and the dramatically improved cancer detection rate that we saw in Pathfinder 2 relative to when added to standard of care screening and what we reported out in our press release around NHS gallery. So we think that is very well understood by many customers, but there's still a lot of education yet to be done. And obviously, the primary care community is enormous in the United States, and ASCO will be a big opportunity for us to share a deeper look at the NHS Gallery trial in all of its glory, and we're very much looking forward to that.

That's great. Very excited for that. Just maybe to touch on that, what does the business kind of look like post-ASCO, pre-FTA approval? We'll pretty much have the totality of the big data sets, but that kind of gets into uses of cash and timing of the Salesforce ramp. So how do you think about maybe managing the pedal and maybe how does FDA approval impact the business? Is it like turning on a faucet or is it kind of a slower build? Thank you.

You know, that's one of the things we're going to have to see is the, you know, impact of FDA approval. You know, certainly our early, you know, early research would suggest it's going to, providers and patients are both going to view that very favorably. And, but it's early days to exactly predict, you know, what the impact of that is going to be.

Yeah, I mean, I just add, I mean, importantly, with fundraising we did last year, you know, we've got the opportunity to, you know, intercept that inflection point, if and when it shows up. So I think we're well situated.

Understood. Thank you.

Thank you. There are no further questions at this time. I will now turn the call back to Grail for closing remarks.

Well, thank you, everyone, for joining today's call. We appreciate the time and your questions, and we look forward to seeing many of you at the upcoming ASCO show.

Ladies and gentlemen, this concludes the call. You may now disconnect.