Logo of jester cap with thought bubble.

Image source: The Motley Fool.

Date

May 5, 2026

Call participants

  • Chief Executive Officer — Robert Ragusa
  • President — Joshua Ofman
  • Chief Commercial Officer — Andrew Partridge
  • Chief Financial Officer — Aaron Freidin

Need a quote from a Motley Fool analyst? Email [email protected]

Takeaways

  • Galleri Test Volume -- 56,000 tests sold, representing a 50% increase in volume year over year.
  • Screening Revenue -- $39.8 million from Galleri, up 37% year over year.
  • Total Revenue -- $40.8 million, reflecting a 28% increase from the prior-year quarter.
  • Non-GAAP adjusted gross profit -- $19.7 million, marking a 38% year-over-year increase attributed to higher volume and lower sample reprocessing costs, partially offset by declining average selling price (ASP).
  • Net Loss -- $93.2 million, an improvement of 12% from the prior-year period.
  • Adjusted EBITDA -- Negative $79.9 million, a year-over-year improvement of 19%.
  • Cash Position -- $823.1 million at quarter-end, with management stating this supports growth initiatives "over the next several years."
  • Sales Force Expansion -- Field sales and medical teams are being expanded, aiming to have most new hires onboarded and trained by midyear, and territories rising from 90 to 120.
  • Provider Adoption -- Approximately 1,300 new Galleri prescribers added during the quarter, with key system launches at Dana-Farber, Rush, OHSU, Cleveland Clinic, and Duke.
  • Digital Health and Employer Growth -- New and deepening partnerships cited, including with Function Health, Hims & Hers, Everlywell, WHOOP, and expanded employee benefit coverage at Intermountain.
  • EHR/Ordering Integration -- New collaborative integrations initiated with Quest and Epic's Aura platform, allowing direct ordering and result management for 450 targeted health systems.
  • FDA Submission -- Final PMA for Galleri accepted, based on data from over 25,000 PATHFINDER 2 participants and prevalence screening round from the NHS-Galleri trial; bridging analysis included for new test version.
  • Clinical Evidence -- Over 174,000 individuals supported in studies backing FDA submission, with data cited as "consistent" across clinical and commercial experience.
  • NHS-Galleri Trial Results -- Observed a>20% reduction in Stage IV cancer diagnoses, but no statistically significant reduction in the combined Stage III–IV endpoint; increased detection of Stage I and II cancers, and a fourfold higher cancer detection rate compared to standard of care screening alone higher detection rate versus standard screening.
  • Guidance -- Management reiterated its annual revenue growth guidance of 22%-32% and confirmed a 10% range remains due to uncertainties in digital health uptake and market channel mix.

Summary

GRAIL (GRAL +15.35%) delivered 50% annual Galleri volume growth and 37% screening revenue growth, driven by expanding provider adoption, increased digital health partnerships, and health system integrations. The quarter featured new collaborations with major health systems and digital platforms—most notably the start of Epic EHR integration, intended to reach 450 health systems, and the continued roll-out of Quest and Athenahealth ordering systems. Management emphasized the completion and FDA acceptance of the PMA for Galleri, referencing clinical data from over 174,000 individuals, and restated the importance of the upcoming full data presentations for the 140,000-patient NHS-Galleri and 35,000-patient PATHFINDER 2 studies at ASCO—key catalysts for further market penetration. The company reported a cash position of $823.1 million and reaffirmed its 22%-32% revenue growth guidance, citing ongoing channel mix changes, price elasticity strategies, and the pending impact of new digital health and EHR partnerships as drivers and variables for the year.

  • New provider adoption included approximately 1,300 new Galleri prescribers and the addition of several major health system customers in the quarter.
  • The majority of Galleri volume remains self-pay, with the brick-and-mortar physician and digital health segments both contributing significantly to growth.
  • More than 30,000 tests have been ordered electronically via Quest or Athenahealth since launch, supporting scalable growth.
  • Emerging channel partnerships—such as Function Health, Hims & Hers, and WHOOP—were highlighted as variables for future volume, though their financial impact is unquantified and factored within current guidance ranges.
  • Guidance was not raised despite outperformance in the quarter; management cited early-year timing and multiple pending catalysts, including ASCO presentations and FDA review outcomes, as reasons for maintaining a conservative outlook.
  • Average selling price declines are expected to be modest in 2026, driven largely by mix, with significant pricing adjustments already incorporated in prior periods.
  • Management detailed sales force expansion from 90 to 120 provider territories, targeting full onboarding and productivity for most hires by midyear, and does not anticipate a return to pre-spinoff sales force size.

Industry glossary

  • MCED (Multi-Cancer Early Detection): Blood-based diagnostic technology designed to detect multiple cancer types simultaneously in asymptomatic individuals.
  • PATHFINDER 2: GRAIL’s prospective study evaluating the Galleri test’s ability to detect cancer across a large, intended-use population.
  • NHS-Galleri Trial: A large-scale, randomized clinical trial with the U.K. National Health Service, evaluating Galleri’s impact on cancer stage at diagnosis and overall detection rates.
  • PMA (Premarket Approval): The FDA’s most stringent process for evaluating the safety and effectiveness of Class III medical devices before marketing.
  • EHR (Electronic Health Record): Digital system for managing patient medical records, test ordering, and results within healthcare provider workflows.
  • Epic Aura: Epic’s platform for integrating third-party diagnostic tests, streamlining the ordering and result processes for providers within Epic health systems.
  • ASP (Average Selling Price): The average price per unit received across different sales channels for a product or service during a given period.

Full Conference Call Transcript

Robert Ragusa: 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. GRAIL sold over 56,000 Galleri tests in the first quarter, a 50% increase in volume year-over-year. Total Galleri screening revenue was $39.8 million, up 37% over the prior year. We are making important strides to enhance provider and patient awareness of MCED.

We continue to grow our partnerships with health systems, which educate physicians and engage the community. We are seeing growing deployment of Galleri in leading systems, including Dana-Farber, Rush, OHSU and Cleveland Clinic and Duke. We are seeing major health systems, including Community Health at Intermountain investing in new and expanded employee benefit coverage of Galleri. 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 employer relationships continue to expand as experience with Galleri grows.

We've invested in the ease of access through our previously announced partnerships with Quest to integrate into their ordering systems and 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 Galleri test 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 Galleri. 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 Galleri is focused on test performance and safety results from the first approximately 25,000 participants in the PATHFINDER 2 study with 1-year follow-up and the prevalence screening round only of the NHS-Galleri trial. The submission also includes a bridging analysis to compare performance of the version Galleri used in the clinical trials to the updated version that has been submitted to the FDA for premarket 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 midyear. We believe this expansion will enable us to continue to drive commercial momentum.

Finally, we're looking forward to the upcoming data presentations for our 140,000 participant NHS-Galleri 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 31. 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.

Joshua Ofman: Thanks, Bob. At GRAIL, we're very excited about the comprehensive data we've been generating to demonstrate the value proposition for Galleri. 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 Galleri's performance at renowned medical conferences, including 2 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 MCED testing.

Women who received a negative MCED result maintained their high adherence to guideline recommended mammography, with greater than 80% undergoing screening in the 24 months after MCED testing, similar rates in the 24 months before testing. As a reminder, Galleri is intended to be used alongside existing standard of care single cancer screening tests, and these findings suggest that MCED testing will not negatively impact participation in guideline recommended cancer screening. Earlier this year, we released top line data from the NHS-Galleri 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 III and IV reduction over 3 rounds of screening. What was observed in the trial was an increase in Stage III cancers detected and a decrease in Stage IV 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 I and II deadly cancers and a fourfold 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 IV cancer diagnosis 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 IV diagnoses is incredibly meaningful because there is a large survival cliff between Stage III and Stage IV for many types of cancer.

Many Stage III cancers can now be treated with curative intent and finding these cancers at Stage III rather than Stage IV 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 U.K. and similar numbers in the U.S., 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 Galleri as a complement to standard of care screening. We are 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 a review of our financials.

Aaron Freidin: Thanks, Josh, and good afternoon, everyone. I'm pleased to 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.

Joshua Ofman: 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 GRAIL and everyone joining today's call who follows our story can appreciate the incredible progress you've led our teams through over the last 5 years, our spinout from Illumina, our commercial expansion and the scaling of our North Carolina laboratory operations. As a result, GRAIL 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.

Robert Ragusa: Thanks very much, Josh. Leading GRAIL and working alongside this extraordinary team has been the greatest honor of my 4 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 the 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 reins shortly to Josh, who has played a central role in driving GRAIL's strategy and execution over the past 7 years. Operator, we can go to Q&A.

Operator: [Operator Instructions] Our first question will come from Subbu Nambi with Guggenheim.

Subhalaxmi Nambi: And great print. The FDA and CMS recently established a rapid pathway in which CMS will propose the NCD for Class 2, 3 breakthrough devices on the same day that the FDA provides market authorization. Given Galleri has the breakthrough device status and would be expected to be a Class 3 device, do you expect Galleri to be eligible for the rapid pathway? Or does the 2029 start date specified in the MCED bill negate this opportunity? Sorry for the long question.

Robert Ragusa: Thanks, Subbu, for the question. We've looked at rapid right now, it's kind of just a framework without a lot of detail. But at a high level, it does look like the characteristics of our test, the breakthrough designation, the fact that we're driving for FDA approval does put us 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 and see how the details unfold for that particular piece of legislation. Josh, I don't know if any other comments on that?

Joshua Ofman: 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.

Subhalaxmi Nambi: Perfect. And how much growth from partnerships like Function Health and Hims & Hers are factored in your guidance for Galleri growth in 2026? And then maybe I missed this, but given the beat, are you raising guidance? I'm hopping through multiple earnings, so pardon of my question here.

Robert Ragusa: Aaron, do you want to take that one?

Aaron Freidin: Yes. So on your first question, Subbu, nice to talk to you. So we've got our guidance, which we're reiterating still the same guidance, not updating it. You 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 Hims & Hers and some of these other new agreements that we've signed, as they implement, we'll see what uptake is like. Depending on how they implement it, it can go quickly, sometimes it doesn't.

Operator: Your next question will come from Kyle Mikson with Canaccord Genuity.

Kyle Mikson: Congrats on the quarter. First one is just a rough bigger picture question. It's been a few months since the NHS-Galleri reveal. Can you talk about the feedback from stakeholders since then? And then very exciting to have the ASCO presentations pretty soon here. Do you expect to have a material change in opinions following those abstracts and perhaps the call with the investors as well?

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

Andrew Partridge: Yes. Thanks, Bob. Thanks for the question. As Bob said, we've seen strong growth through Q1 kind of year-over-year, and that growth has 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 Galleri 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 Galleri with agreements in Q1 and also added new digital health customers in Q1, all of this in the midst of the NHS-Galleri data being released.

I think specifically to the NHS-Galleri 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.

Kyle Mikson: Yes. Wow, that was great. I guess my final question or second question is going to be about expansion opportunities kind of 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, can you just talk about your enthusiasm of what Epic could do for you and then expansion plans to Oracle, Cerner or things like that?

And then just on the sales force expansion as well, I mean, are you looking at like pretty healthy tailwinds in second half due to things like Epic and sales force expansion as well?

Robert Ragusa: Yes. So if you think about maybe the first part, 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, that is a huge part of the kind of easy button within health systems to be able to have the Galleri test within their normal workflow, both from the ordering side as well as the test results coming in. So it really just fits into the entire workflow of a physician. So it makes it much more likely to be able to be integrated into a health system. So 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 we look for that to build over the second half of the year. Andy, maybe some discussion on the Quest side, what we're seeing there as well as the sales force expansion.

Andrew Partridge: 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 Quest 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 U.S. And essentially, any health system that was on the Epic system in November 2020 or later is going to be eligible for our Epic or 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-Galleri and PATHFINDER 2 and potentially an FDA approval at some point 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 Galleri that we're reporting today.

Operator: Your next question will come from Dan Brennan with TD Cowen.

Daniel Brennan: Maybe just starting off, I know there's a question already about the feedback so far since the NHS-Galleri 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 IV shift, kind of what the feedback has been from oncologists? And any particular cancers where oncologists or experts are feeling most optimistic about that shift?

Robert Ragusa: So with respect to the reduction in Stage IV, the 20% plus reduction in Stage IV in particular, 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 -- since that data has been released, we've seen more favorable things from oncologists who truly understand just how important that reduction is. So we've -- I think over the last 5 years with Galleri being out in the market, we've seen good understanding from primary care physicians and -- but the oncologist community has probably lagged 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 piece in particular, is resonating really nicely. Josh, any --

Joshua Ofman: No. Yes.

Robert Ragusa: No. Go ahead.

Daniel Brennan: Okay. Great. And then maybe just in terms of the guidance range for the year, I know there's a couple of questions asked about like the buckets and the drivers there. But could you help like zoom out a little bit and just give a little bit more color about between health systems, concierge medicine direct to PCP, kind of where are you guys seeing like the most traction right now? And how you think about the rest of the year in terms of the guide? Does it remain in those buckets? Or has anything changed on that front?

Robert Ragusa: Yes. Maybe I can give a little bit, and then I'll pass it over to Aaron and Andy to give some more color. So the self-pay piece remains the majority of Galleri's volume, accounting for kind of 2/3 plus of the volume. In terms of volume growth, the brick-and-mortar physicians continue to be strong. Clearly, as we talked about our integrations with Quest and Athenahealth, that helped add new providers and reduce order friction. Going forward, we do see the sales force expansion continuing to drive extra volume. Digital health continues to provide a great opportunity in the self-pay market.

Here, we have access to people who are used to being in the self-pay market, and that's continued to do quite well with partners like Function Health and Everlywells. And then we have the new partnership coming on with Hims and then WHOOP that we just announced. So as Aaron mentioned, we'll have to see just how fast the uptake of those goes. But I think that gives you some sense. Aaron, anything to add on the color around the guide?

Aaron Freidin: No. I mean I think it's -- Bob has covered it. We'll track to see how the quarters go and look at it again next quarter.

Operator: Your next question will come from Catherine Schulte with Baird.

Catherine Ramsey: Maybe first on guidance. I think ASPs stepped 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?

Robert Ragusa: Yes. So maybe I'll hit the ASP piece. So if you recall, our vision all along has been to operate Galleri at population scale, and so we have plans for price reductions over time. As we talked about, we made significant investments in our new scalable platform and have rolled that out throughout from late '24 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 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. So within 2026, we would only expect relatively modest decline to continue other than things driven purely by mix. So as the mix of the various channels 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 with an overlay of maybe a slight decline in ASP per channel.

Catherine Ramsey: Okay. Anything on 2Q?

Robert Ragusa: I mean again, we expect our growth for the year to be between 22% and 32% on the revenue side.

Catherine Ramsey: Okay. And last question for me. We've seen some competitors increasing their DTC advertising. We had one announced a celebrity spokesperson a couple of weeks ago. And you've talked about the sales force expansion, but any plans you have on the advertising side to make sure you're getting brand recognition with consumers?

Robert Ragusa: So we have been doing a little bit more certainly in the social media channels and things to get the message out. One of the things we've actually found is the competitors by the competitors advertising the MCED space. That's actually brought a lot more awareness for MCED. So we're actually seeing -- while it's obviously a competitive -- potential competitive threat, we're actually seeing a fair amount of tailwinds from that as people get more and more acclimated to the whole MCED space to get more knowledge about the MCED space. And when our sales team can go in and describe our product, someone is now aware and interested, we usually end up doing very well there.

So, so far, largely a headwind, those we'll 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 probably not to the level that some of the other competitors are putting out there.

Operator: Your next question will come from Doug Schenkel with Wolfe Research.

Colleen Babington: This is Colleen on for Doug. A bit of a follow-up from Kyle's question on sales force 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?

Robert Ragusa: Andy, do you want to take that one?

Andrew Partridge: Yes. 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.

Colleen Babington: All right. And then just one on the FDA approval process for Galleri. 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 MCED?

Robert Ragusa: Josh, do you want to weigh on that?

Joshua Ofman: Sure. As you mentioned -- 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.

Operator: Your next question will come from David Westenberg with Piper Sandler.

David Westenberg: I just want to hit on the topic of the 22% to 32% guidance, but you obviously came in at 37%. So can you talk about -- 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, whether it be like maybe you saw really good seasonality? Is there a channel mix? Is there ASPs that would make it come in below what you came in, in Q1?

Robert Ragusa: I'll start and then have Aaron -- I think first part is it's just early in the year. Obviously, this is a pretty important year for us with our FDA filing. We have a number of factors out there. We have the sales force 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 we also mentioned just some of the competitive pressures out there. So in that whole mix, we kept guidance the same. And as Aaron mentioned, we would update again, look to see if there's anything new to report out at the end after Q2. Go Aaron.

Aaron Freidin: Bob, nailed it again.

David Westenberg: Right. Then maybe I'm just going to move on to the Epic integration. So you announced that the 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 -- not DTC channel in the back half of the year? And then can that flow through for 2027? Can that start to be the bigger channel? Or am I too early on that?

Robert Ragusa: Andy, do you want to give some color on that one?

Andrew Partridge: Yes. In terms of 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, health system would be HCA. One health system would be Mayo. So these are 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 is 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 or integration. And could you repeat the last part of your question because I didn't quite catch it.

David Westenberg: I was just thinking about how we should think about mix between hospital and DTC channels in 2027 and beyond.

Andrew Partridge: 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. Yes, 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 Galleri. Epic then is the easy button for them that improves the provider experience by streamlining Galleri ordering, resulting and follow-up. But as I said, health systems are very excited about Epic Aura integration with Galleri.

That's going to sit alongside our Athena and Quest electronic order integrations as well.

Operator: Our last question will come from Bradley Bowers with Mizuho.

Bradley Bowers: Just want 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-Galleri 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 is this group of the eventual customers, are they kind of conducive to these slices? Do they understand the superior sensitivity of Galleri or specificity? And also that kind of leads into how competitor dynamics have been we're about 6 months with other tests on the market.

Robert Ragusa: Josh, do you want to?

Joshua Ofman: Yes, that's a great question. I think that it's fair to say that our customers are fairly well versed in the performance of Galleri. Galleri performance has been demonstrated in multiple large studies now, from case control studies to interventional studies and intended use path, the PATHFINDER study, PATHFINDER 2. And now they're going to see the full data set from NHS-Galleri. But as it relates to performance, we think the customers absolutely understand the very high specificity, the safety profile of Galleri, its ability to detect where in the body a cancer signal comes from with very high accuracy.

It's 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-Galleri. 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 more -- a deeper look at the NHS-Galleri trial in all of its glory, and we're very much looking forward to that.

Bradley Bowers: That's great. Very excited for that. Just maybe to touch on that, what does the business kind of look like post ASCO pre-FDA 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 sales force 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?

Robert Ragusa: One of the things we're going to have to see is the impact of FDA approval. Certainly, our 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 what the impact of that is going to be.

Joshua Ofman: Yes. I mean I'd just add, I mean, fortunately, the fundraising we did last year, we've got the opportunity to intercept that inflection point if and when it shows up. So I think we're well situated.

Operator: There are no further questions at this time. I will now turn the call back to GRAIL for closing remarks.

Robert Ragusa: 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.