On Wednesday, GRAIL (NASDAQ:GRAL) discussed second-quarter financial results during its earnings call. The full transcript is provided below.
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The full earnings call is available at https://grail-q2-financial-results-2026.open-exchange.net/registration
Summary
GRAIL reported a strong second quarter 2026 with revenue of $44.7 million, a 26% increase year-over-year, driven by a 35% increase in Galleri test volumes.
The company completed a $110 million financing round with Samsung, aimed at supporting international expansion, particularly in South Korea, Japan, and Singapore.
GRAIL continues to pursue FDA approval for the Galleri test, expecting an advisory committee meeting in the fall, and aims for approval in early 2027.
The Galleri test showed strong performance in clinical trials with a false positive rate of less than 0.5%, demonstrating significant improvements in early cancer detection.
Management emphasized their competitive advantage due to extensive clinical validation and addressed potential noise in the market from competitors with unproven tests.
Full Transcript
OPERATOR (Operator)
Good day, ladies and gentlemen, and welcome to the GRAIL second quarter 2026 earnings call. At this time all participants are in 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.
GRAIL Investor Relations
Thank you, and thank you all for joining us today. On the call are Joshua Ofman, our Chief Executive Officer, Aaron Frieden, Chief Financial Officer, Sir Harpal Kumar, Chief Scientific Officer and President, Global Clinical and Medical Affairs, and Andy Partridge, Chief Growth 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 or 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 Securities and Exchange Commission, including the risk factors section in GRAIL's most recent Annual Report on Form 10-K and the Quarterly Report on Form 10-Q we plan to file for the second quarter of 2026.
This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit and adjusted EBITDA, which excludes certain specified items. Our non-GAAP financial measures are intended to supplement your understanding of GRAIL's financials. Reconciliations of the non-GAAP measures to the most directly comparable GAAP financial measures are available in the press release issued today, which is available on our website.
With that, we turn to Josh.
Joshua Ofman MD, MSHS — Chief Executive Officer
Thank you. Good afternoon, everybody, and thanks for joining us to review the results of the second quarter 2026 and discuss recent business updates. GRAIL continues to execute across our clinical and commercial priorities. We launched the Galleri test in 2021 after our approximately 6,000-participant interventional PATHFINDER study, which was conducted under an FDA-approved investigational device exemption and read out and demonstrated strong performance and safety in a screening population.
For several years, PATHFINDER was the only interventional study that clearly demonstrated the benefits and evaluated the potential harms of deploying an MCED test in the intended-use population. Since then, we've read out two additional large studies: our 35,000-participant PATHFINDER 2 study in North America and the groundbreaking 140,000-participant NHS-Galleri trial in England, which included three annual tests. We recently presented detailed performance, safety, and clinical utility results from these studies at the 2026 American Society of Clinical Oncology Annual Meeting, and they are currently under review for publication, further establishing Galleri as the only MCED with extensive clinical validation from interventional studies. These data in the asymptomatic screening population are critical for physicians and patients to understand test performance, as case-controlled studies can fail to replicate performance when tests are rolled out in an intended-use population. We're extremely proud of the unparalleled performance demonstrated in these studies in the screening population, and we're focused on driving to FDA approval and subsequent Medicare and commercial reimbursement.
Galleri test performance is highly differentiated, with a false positive rate of less than 0.5%, resulting in at least three to six times fewer false positives than other MCED tests in development. Our technology at GRAIL was designed specifically for population-scale MCED screening. Our extensive research, published in top-tier journals, concluded that methylation holds the highest biological information density, which is why GRAIL's proprietary methylation platform, the largest of its kind, is uniquely capable of delivering high-accuracy detection and precise localization.
We have published, to our knowledge, the largest head-to-head genomic feature comparison study in the entire field, and we showed that combining other approaches considered did not improve performance over our proprietary methylation technology. Adding these other features only introduced additional complexity, cost, and biological noise, and the field is increasingly moving to methylation as the technology of choice, further validating our approach.
Today in the market with Galleri, we continue to expand access through new and existing partnerships, and we are accelerating our international expansion activities related to that. In the second quarter, we completed the previously announced $110 million financing with Samsung. Alongside that closing, we began work with Samsung C&T Corporation on our strategic collaboration. As a reminder, we and Samsung C&T Corporation will work together to commercialize the Galleri test in South Korea, with the potential to expand into additional Asian markets including Japan and Singapore.
The $110 million investment in GRAIL represents a long-term investment to support our growth and international goals. We were very pleased to complete this financing, and we look forward to moving forward with Samsung to introduce our MCED technology to patients throughout Asia. In the U.S., we continue to see growing physician adoption of the Galleri test. We sold over 61,000 Galleri tests in the second quarter, a 35% increase in volume year over year.
Total Galleri screening revenue was $42.6 million, up 24% over the year prior. For the first half of 2026, we saw Galleri test revenue growth of 30% year over year to more than $80 million and Galleri test volume growth of 42% to more than 117,000 tests. We announced early in 2026 the planned expansion of our field sales and medical teams based on the positive performance and clinical utility results observed in our PATHFINDER 2 and NHS-Galleri trials.
This expansion was substantially complete at the end of the second quarter. New personnel have been onboarded and trained and are now in the field, and initial feedback from Salesforce engagements with physicians since ASCO has been really positive. Last month, we announced a collaboration with Priority Health to enable its employer groups to add the Galleri test to their existing screening coverage. Priority Health is a nationally recognized nonprofit health plan with more than 1.4 million members in Michigan and nearby states.
Priority Health launched coverage for Galleri within certain plans in 2025, and our collaboration announced in July marks a promising expansion of this partnership. Moving to our clinical evidence base, we recently shared strong clinical utility, performance, and safety results from our NHS-Galleri trial and PATHFINDER 2 studies at the recent ASCO Annual Meeting in May. Although the primary endpoint for the NHS-Galleri trial of a combined reduction of stage 3 and 4 cancers was not met, we believe the other results of this study demonstrated very strong performance, safety, and utility across both studies.
Adding Galleri to standard of care increased the cancer detection rate by 4 to 6.5 times. The Galleri test demonstrated very consistent performance with a false positive rate of less than 0.5% and positive predictive values ranging from 50% to 60%. Galleri also demonstrated high accuracy in predicting cancer signal of origin, enabling efficient and patient-centered diagnostic evaluations. Today, standard-of-care screening finds only about 14% of cancers in the U.S. and about 6% of cancers in the U.K. By adding Galleri, we estimate that those figures can increase to 50% or more, and indeed in PATHFINDER 2 this number was 60%. This represents a substantial improvement that expands detection of clinically meaningful cancers that otherwise lack recommended screening. Across these two studies, approximately 40% to 50% of the Galleri-detected cancers were found at stages 1 and 2, and approximately 70% were found at stages 1 through 3.
Remarkably, in the NHS-Galleri study, Galleri detected 366 stage 1 and 2 cancers, many more than the 290 cancers detected at any stage by the entirety of the U.K.'s standard-of-care screening program in the control arm. This is truly remarkable. The promise of multi-cancer early detection is not just in finding cancer, but in finding it early enough to open the door to curative treatment options for as many people as possible. What is clear across these groundbreaking trials is that the Galleri test detects a large number of asymptomatic cancers in stages 1 through 3, the majority of which have the opportunity for curative-intent treatments.
Together, these findings underscore the consistency and actionability of the Galleri test results and demonstrate that adding Galleri to standard-of-care screening has the potential to improve the effectiveness and efficiency of our current national screening program. This is critical for providers, regulators, and payers as they evaluate the clinical and economic value of Galleri alongside standard-of-care screening. These data support the potential of MCED screening at population scale to identify cancers at earlier stages, when treatments are more effective and are potentially curative.
Turning now to our regulatory process, we submitted our premarket approval application to the FDA in early '26, and we remain in an ongoing iterative review process. We are very confident in the data package that's been submitted. Galleri's performance has been validated and replicated in multiple rigorous intended-use, population-level studies. We have consistently shown that Galleri can detect asymptomatic cancers well over and above the standard of care, and the evidence clearly demonstrates that Galleri can be useful and safe when implemented at scale.
Our PMA for Galleri is focused on test performance and safety results from the first approximately 25,000 participants in the PATHFINDER 2 study with one year of follow-up, and the prevalence screening round, or the first year, of the NHS-Galleri trial. The submission also includes a bridging analysis to compare performance of the version of Galleri used in these clinical studies to the updated version that has been submitted to the FDA for premarket approval.
As Galleri is a first-of-its-kind technology, and multi-cancer early detection represents a potential paradigm shift in cancer screening, we do expect the FDA to convene an advisory committee for Galleri in the fall. The FDA will announce specific timing of an advisory committee. Turning now to the evolving market environment, as additional MCED tests have launched, a few things are very critical to mention. Other MCED products have been introduced based only on observational case-control data and have yet to evaluate the benefits and harms in an actual screening population.
First, that means it is unknown how the purported benefits of these tests shown in case-control data will translate, if at all, into performance when deployed into an asymptomatic screening population; and, without interventional studies, it's not clear whether the diagnostic pathways and procedures have been developed to support physicians and patients after a positive test. Second, MCED tests with high false positive rates may expose patients to significant risks of radiation exposure and invasive diagnostic tests, which carry potential for complications and increased morbidity.
Until these tests have been robustly studied and validated in the intended-use screening population, they represent an unknown benefit-risk profile and should be considered experimental screening tests at this stage. When we launched Galleri, we deliberately chose to do so only after reporting results from a prospective interventional study under an FDA-approved investigational device exemption in the screening population. We believe that patients deserve, and the field demands, this level of robust evidence because the true litmus test of test performance—both benefits and harms—is demonstration in interventional clinical studies in the actual intended-use population. Now, why do I say this? This is because case-controlled data will not always replicate in interventional studies. For example, after very strong performance for the CancerSEEK assay was observed in a case-controlled study published in a top-tier journal, Science, the Detect-A study failed to replicate performance and safety in an interventional study, and as you know, this test is currently not available or on the market.
Beyond study rigor, Galleri test characteristics stand apart in the field. Based on data from observational case-controlled studies, experimental MCED tests are operating at a three to five times higher false positive rate. They detect a smaller number of cancer types, and some have no ability to predict a cancer signal origin, which we believe is necessary for safety and performance of any MCED test. In a field where hope and hype can easily collide, GRAIL is defined by rigorous science and validated by the most extensive evidence base.
We believe we chose the right biological signature of cancer after unbiased comparisons. We have built the most advanced proprietary technology to interpret that signal, and we have proved its performance in the real world on an unprecedented scale. I'll now hand off to Aaron for a review of our second quarter financials.
Aaron Frieden (Chief Financial Officer)
Thanks, Josh, and good afternoon, everyone. Second quarter results were strong with revenue of $44.7 million, up $9.1 million, or 26%, as compared to the second quarter of 2025. Total revenue for the second quarter consisted of $42.6 million of screening revenue and $2 million of development services revenue. Screening revenue was up 24% as compared with the second quarter 2025 with test volumes of more than 61,000, an increase of 35% over the second quarter of 2025.
Net loss for the quarter was $110.2 million, a decrease of 3% as compared to the second quarter of 2025. Non-GAAP adjusted gross profit for the second quarter was $21.6 million, an increase of $5.4 million, or 34%, as compared with the second quarter of 2025. Primary drivers of the increased gross margin were improved fixed cost leverage from higher volumes and a decrease in sample reprocessing costs, partially offset by a decrease in ASP. Adjusted EBITDA for the second quarter was negative $90.3 million, an increase in adjusted EBITDA loss of $11.9 million, or 15%, as compared to the second quarter of 2025.
We ended the second quarter with a cash position of $861.6 million, which includes the $110 million strategic investment by Samsung, which closed in June. Our cash balance today provides us with financial flexibility as we advance key priorities, including securing regulatory approval and reimbursement for Galleri in the United States. Back to you, Josh.
Joshua Ofman MD, MSHS — Chief Executive Officer
Thank you, Aaron. We're really pleased with the continued growth for Galleri and the progress we're making towards FDA approval and broad-based access, and we anticipate continued progress over the next year. With ASCO behind us, our expanded field teams are now fully equipped to educate clinicians about our groundbreaking trial results and continue market development, and initial feedback from the field has been really positive. We look forward to potential FDA approval of Galleri, expanding distributor partnerships internationally, progressing R&D on Galleri improvements and cost of goods reduction, and publication of the NHS Galleri and PATHFINDER 2 studies, as well as additional analyses from our extensive clinical program. Operator, we can now go to Q&A.
OPERATOR (Operator)
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 related follow-up today. We'll wait one moment to allow the queue to form.
Our first question will come from Subu Nambi with Guggenheim. Please unmute your line and ask your question.
Subu Nambi, Analyst at Guggenheim
Hey team, thank you for taking my question. As you anticipate an FDA AdCom in the fall, where do you think the FDA will focus on? Like what type of questions, and how are you preparing for those questions?
Joshua Ofman MD, MSHS — Chief Executive Officer
Hi Subu, thank you for the question. So, you know, we are obviously getting ready and preparing internally. We don't know the nature of any of that information at this time, but we should, you know, obviously we'll be informed about that as the time approaches. We're waiting to hear something from the FDA as it relates to timing.
Subu Nambi, Analyst at Guggenheim
Okay, that's helpful. And then, given all the leadership changes at the FDA and the delays we have seen recently when it comes to finding the right panelists for AdComs, is there a risk this meeting pushes into next year at all? I know it's an unfair question.
Joshua Ofman MD, MSHS — Chief Executive Officer
Well, it's fine. We don't know the answer to that question. We know that the division that we're working with has been fairly stable at the FDA, which has been very, very positive and productive, and we continue our iterative review with them. But I couldn't really comment on their ability to find experts.
Subu Nambi, Analyst at Guggenheim
Okay, can I squeeze one more? Would you expect CMS to wait for an FDA approval before better defining the NCD criteria for an MSAID test?
Joshua Ofman MD, MSHS — Chief Executive Officer
You know, again, it's a good question. I'd be speculating if I tried to answer it. We do know that CMS's coverage authority is only for FDA-approved products. So our assumption has been that they would only undertake a national coverage analysis upon an FDA approval. Whether they're going to set specific coverage criteria is unknown.
Subu Nambi, Analyst at Guggenheim
Fair. Thank you so much, guys.
OPERATOR (Operator)
Our next question will come from Kyle Mixon with Canaccord Genuity. Please unmute your line and ask your question.
Kyle Mixon, Analyst at Canaccord Genuity
Hey guys, thanks for the questions. Congrats on a strong quarter. Following up on Subu's questions about FDA, so maybe Josh, like, it wasn't clear to me what the specific communication with the FDA was for you to now anticipate the meeting AdCom in the fall. So if you could talk about that, that'd be helpful. And then additionally, you know, in the past you've talked about like an early '27 sort of approval timeline. Let's say this is like mid-fall or something.
How would that affect your new timeline for FDA approval? Thank you.
Joshua Ofman MD, MSHS — Chief Executive Officer
No, thanks for the question, Kyle. You know, we have long stated publicly that we would anticipate that a groundbreaking technology like an MSAID test like Galleri, that is really changing the potential cancer screening paradigm, would get an advisory panel. And we continue to believe that. There's no specific information that's been made public yet from the FDA about that, but we certainly are anticipating that an AdCom would occur. The timing of it, you know, has not been made public yet—that's still to come.
And our current anticipation for potential approval as it relates to timing remains unchanged. You know, we would expect it to occur in the first part of 2027.
Kyle Mixon, Analyst at Canaccord Genuity
Perfect, thanks for that. And then on competition, you know, you called that. That's interesting. It doesn't seem like there's been a volume impact, but how is that impacting your pricing? It looks like ASP in the quarter was like $700 or something around there. And then, you know, kind of on that note, I think USPSTF is meeting later this month. Could they possibly talk about MSAID at that meeting? Or how do you think that progresses given it's more noise in the marketplace than some of these other entrants recently?
Joshua Ofman MD, MSHS — Chief Executive Officer
Yeah, it's a fair question. Let me take your second question, and I'll have Andy address your first. As it relates to the USPSTF, I think there's just a lot that's unknown right now about the USPSTF. It's unknown what its composition is going to be, what its focus will be, and I think, you know, before there's an FDA-approved product on the market, it's, in my mind, less likely that they're going to take MSAIDs up irrespective of the amount of noise that's in the market or not.
But there's just a lot unknown about the USPSTF and its mandate at this time. Your first question, which was about the impact of competition on our pricing, I'm going to let Andy discuss that.
Andy Partridge (Chief Growth Officer)
Yeah, I think, first of all, the ASP decrease in second quarter '26 was the result of both expansion of digital health volume and also lower employer pricing, which was planned. That reduced employer pricing has come along with the benefit of strengthened partnerships with those employers, such as specific marketing commitments and blood draw events. In terms of competition, there's definitely been some active competition that we've seen that has been stepped up.
As I'm sure you've also seen, it has been causing some customer confusion in the market, given, as Josh outlined earlier, these—what we would call experiments or MSAIDs—do not have data in the screening population, so many of their performance characteristics are unknown to those prescribing physicians. They also have higher false positive rates. So what we're seeing with physicians that have experimented with some of these MSAIDs is quite a bit of confusion due to these higher false positive rates and unclear performance characteristics.
That's something that our sales team are following up with those customers to reinforce Galleri's extensive clinical program that we've conducted and the clinical results that we've presented and published. And as Josh said, the initial reactions from these conversations where we followed up with our customers with the data that was presented at ASCO for both PATHFINDER 2 and NHS Galleri has been very promising and very favorably received.
Joshua Ofman MD, MSHS — Chief Executive Officer
I think that's great, Andy. I would just add one other thing. You know, the noise that's been interjected into the market, we expect that—our anticipation is that we will have an FDA approval, and that will create a bifurcation in the market and clear up a lot of that noise. We expect the market really to evolve: one side with Galleri as a well-validated and potentially FDA-approved MSAID, and then the other side of the market with the other MSAIDs that are still, quite frankly, in development, with unknown risk-benefit profiles in the intended use population, and so they'd be considered very experimental.
So we see that bifurcation coming, and we look forward to executing upon it.
OPERATOR (Operator)
Our next question will come from Bradley Bowers with Mizuho. Please unmute your line and ask your question.
Bradley Bowers, Analyst at Mizuho
Hey, thank you for taking my questions. Maybe just wanted to click on the salesforce expansion—obviously a pull-forward of some of the costs. Just wanted to hear about why the timing is right. Seemingly the first part of 2027 timeline seems coincident with expected productivity ramp. But also just wanted to hear about if you knew about the AdCom scenario from the FDA kind of when you allocated this size, and if this is kind of the max salesforce you expect.
Andy Partridge (Chief Growth Officer)
Yeah, we pulled forward the salesforce expansion really on the back of the NHS Galleri and PATHFINDER 2 data that we announced earlier in the year. Given how excited we were with both sets of that data, that salesforce expansion is essentially complete now—those sales members are now in the field. We expect to see the true benefit of that additional salesforce horsepower as we go through the rest of the year. And the other reason that we did this is to have those new salespeople in territory, all trained, so that they can truly meet the moment of FDA approval, as Josh outlined, as this is going to be a landmark event for GRAIL, really establishing Galleri as the gold-standard MSAID.
Bradley Bowers, Analyst at Mizuho
Got it. And just real quick, would you give a number, just because of competitors—we do know a lot of them—and then just actually totally switching gears on the panel: do you think this would make it maybe easier or harder for the incremental MSAID test? Asking just because the government initiative right now seems to be just trying to ease the pathway towards getting MSAID tests, adding more to the market, but obviously the panel would be differentiated.
So wanted to hear if you think it would be a competitive advantage, an extra barrier to entry, or if it might have the adverse effect of making it easier for other MSAIDs down the line. Thank you for the questions.
Joshua Ofman MD, MSHS — Chief Executive Officer
Just to clarify, when you say a panel, do you mean an advisory committee panel, or which panel?
Bradley Bowers, Analyst at Mizuho
Sorry, the AdCom. I apologize. Yes, this fall. The meeting this fall.
Joshua Ofman MD, MSHS — Chief Executive Officer
Yeah. No, an AdCom. Look, the reason we expect an AdCom is because typically when the FDA reviews a kind of groundbreaking, pioneering type of technology, particularly one that can have this kind of impact on public health that is really paradigm changing, they typically hold an AdCom because they want to get advice from other experts. The AdCom will be completely about Galleri, will not be about the field of MCEDs. It won't be about other MCEDs.
It'll be just about our data package that we submitted to the FDA. So we don't really view it as a competitive advantage or disadvantage. We view it as part of the FDA approval process for a groundbreaking technology like Galleri. And to your further question, I don't think that that has necessarily any bearing on whether there will be AdComs for future MCEDs. And I don't see any MCEDs right now even on the horizon doing registrational trials or anything like that.
So it's really hard to set.
Andy Partridge (Chief Growth Officer)
Yeah, I think just building on Josh's point, what the outcome and the FDA approval is going to do is establish that approval bar for future MCEDs. And that's why we're excited for this panel and for the anticipated FDA approval, that it is going to set that bar for future MCEDs coming forward.
OPERATOR (Operator)
Our next question will come from Dan Brennan from TD Cowen. Please unmute your line and ask your question.
Dan Brennan, Analyst at TD Cowen
Great, thanks. Congrats on the quarter. Thanks for the questions. Maybe just one more on the panel since it's obviously the topic. So, Josh, you sounded pretty definitive that there'll be a panel, the FDA will alert us when, you know, kind of when the time is right. Can you just share any color? Like, so does that mean like an outright decision popping up one day is off the table? Like, just what's the level of the discussions that you have with FDA under these types of processes? And just anything you could share on that front would be helpful.
Joshua Ofman MD, MSHS — Chief Executive Officer
Yeah. There's not a lot we can share until the FDA decides to make a public pronouncement one way or the other. But from the very outset, we have been anticipating an AdCom. We've stated that, you know, numerous times. We don't see any reason why that wouldn't be the case. And so really it's just our own internal preparation at this point until the FDA decides to make a public pronouncement. But we're, we're prepared for one. We continue to prepare.
We feel very confident about the evidence package that we've submitted to the FDA. We've been in a very productive, iterative review process and going through all the relevant steps of inspections and other things that you would expect going into a PMA. So things are progressing well and we look forward to hearing more from the FDA.
Dan Brennan, Analyst at TD Cowen
Great, thank you. Is there anything you can share about the back and forth? Like in terms of. Obviously you can't get into specifics, but I'm sure there's a certain cadence to questions and responses all, but I'm not sure how you might categorize or, you know, if there's anything you could share on that front.
Joshua Ofman MD, MSHS — Chief Executive Officer
You know, not really. I mean, it's pretty typical. There have been, you know, a series of questions, we've responded. You know, there's been a series of inspections, we've, you know, performed through those. And so it's just a very standard process. Not, not much I can really share.
Dan Brennan, Analyst at TD Cowen
Okay. How about the marketing since ASCO? You know, I know that you guys were kind of held back a bit from being out in the field since the NHS Galleri headline was out, but you wanted to wait until you presented the full data set at ASCO. Now that that was out, can you just share any color about how, like what the plan has been in the, you know, in the last six weeks or so or eight weeks? Excuse me, what have you guys done? How many customers have you hit?
What's been the response? Anything on that front to kind of provide color on?
Andy Partridge (Chief Growth Officer)
Yeah, we trained all of the salesforce the week after the ASCO meeting, so we plan to do that. We also trained all of our new salesforce that we brought on board in terms of the salesforce expansion. And our sales teams have been out there talking to customers, both healthcare providers and to employer customers. The reaction has been for very favorable from customers, as we've explained to them, both the Pathfinder 2 data and the NHS Galleri data.
Really establishing the Galleri is the only MCED proven to reduce stage four diagnoses and physicians have reacted very favorably to that. And really, this has been the promise of Galleri all along to increase early stage detection and reduce late stage detection, enabling more patients to receive curative intent therapy. So, yeah, everything very promising up until this point.
Dan Brennan, Analyst at TD Cowen
Great. And maybe just, I'll say two more in publication. Just latest thoughts there timing when we might expect the data to be in a, you know, a leading journal. Great. And then maybe so assuming FDA approval comes at some point this fall, early next year, obviously Medicare will have to follow the decision there. But in the interim what type of impact will FDA approval do you think have upon either? Could some payers adopt then will maybe self insured plans look to do anything? Volumes. Just what's the meaning of FDA approval? Do you, you think on the business, you know, say like in that 12 month period between that decision and when the Medicare decision comes.
Andy Partridge (Chief Growth Officer)
Yeah, thanks for the question. So yeah, FDA approval is really the gate that a lot of payers have been waiting for to really dig into Galleri and serious conversations. So we're looking forward to that. Also many employers have told us that they're waiting for FDA approval as well. So that's going to put a wind at our backs with both employers and with payers going forward. And then of course healthcare providers, Josh and I have talked about the confusion that's being caused by experimental MCEDs promoting their unproven tests.
FDA approval is going to give providers the confidence that Galleri is the gold standard MCED. So we feel that that's also going to give our sales teams a lot of confidence going forward in terms of their sales efforts to provider clinics.
Dan Brennan, Analyst at TD Cowen
Terrific. Thank you all.
OPERATOR (Operator)
Our next question will come from David Westenberg from Piper Sandler. Please unmute your line and ask your question.
Karan Patel, Analyst at Piper Sandler (for David Westenberg)
Hey guys, it's Karan Patel on for David Westenberg. And I'll maybe shift gears here if you could speak to the Illumina royalty resuming sometime in Q4. How could we think about margins for Q4 and then specifically for full year 27?
Aaron Frieden (Chief Financial Officer)
Yeah, Karan. So that royalty will kick in toward the end of Q4. So I wouldn't. It's not going to have an impact on Q4 in any meaningful way. And you know, we've been disclosing what that royalty would be every quarter so far in our, in the financials. So you can, you can see what that would have been if we had been paying it. You know, we've disclosed in the financials, it's, you know, 7 to 9%. 7% royalty, I believe. And you know, you can do your modeling to see what the impact would be based off of the volumes that you're expecting and the ASPs.
Karan Patel, Analyst at Piper Sandler (for David Westenberg)
Understood. Thank you.
Aaron Frieden (Chief Financial Officer)
So minimal for 4Q.
OPERATOR (Operator)
Yep. Our next question will come from Callum Tishmarsh from, from Morgan Stanley. Please unmute your line and ask your question.
Callum Tishmarsh, Analyst at Morgan Stanley
Yeah, great. Thanks for taking the question, guys. Sorry again to move back to the AdCom. I was just reading through the transcript from the Q4 call back in February and the message did seem to be that you were prepping for an AdCom, but one likely wasn't necessary. So I'm still just trying to unpackage what perhaps has changed maybe from the questions that you've had from the FDA to the tone that you've given today. And I realize you can't perhaps go into too many of the specifics, but just some guidance would be helpful.
Joshua Ofman MD, MSHS — Chief Executive Officer
Sure, that's fair. There's nothing that's changed in our minds or in our point of view about the FDA AdCom. You know, I'm not sure what you're reading into prior comments. We've, we've been very consistent saying that we are expecting that there will be an AdCom, and we still expect that and we're fully prepared for that. In fact, we look forward to the opportunity to really discuss this data package which is unprecedented in performance and scale with the outcome.
Callum Tishmarsh, Analyst at Morgan Stanley
Okay, fair enough. And then, you know, some, some pretty sizable financing completed with Samsung in the quarter. Can you maybe just speak to the level of engagement there and how we should be thinking about the regulatory commercial timelines in South Korea, Japan and Singapore.
Aaron Frieden (Chief Financial Officer)
Thank you. Yeah, it's Aaron again. Yeah, so we closed that toward the end of the quarter and we're just kicking off those, those discussions now around distribution in the near term and then, you know, any sort of longer term strategic engagement. As you recall, we were under CFIUS review during that period and we weren't, weren't engaging with each other as such. So we'll be able to provide more color on that as we move through the year.
OPERATOR (Operator)
Our last question will come from Robert Bamberger with Baird. Please unmute your line and ask your question.
Josh, Analyst at Baird (for Robert Bamberger)
Hi guys, this is Josh on for Abi. Thanks for taking my question. I guess first, another solid quarter for Galleri here. What was the primary growth driver in the quarter? Was this more on new physician adds or improving order rates among existing physicians?
Andy Partridge (Chief Growth Officer)
Thanks. Thanks. Self pay remains the majority of Galleri's volume accounting for about 70% of sales. We see that most of the volume is coming from brick and mortar physicians. And we added again about 1,000 new ordering providers in Q2. Depth of prescribing continues to increase over time and our electronic order integrations with Quest and Athena are also both bringing on new prescribers themselves and helping increase the depth of prescribing as well.
Given we don't just want to have the best performing test and the gold standard MCED, we also want to have the easiest test for prescribers to prescribe to their patients. We also continue to see very strong growth in our digital health business from both new and existing digital health partners. We've seen continued expansion in employers that are offering the test and also expansion in some new digital health partners and also as we announced, expansion in our payer partnerships with Priority Health, now joining a number of other ASO payers who have decided to offer the Galleri test to their employer base of customers.
Josh, Analyst at Baird (for Robert Bamberger)
Great. And was just wondering too, with the NHS, how have discussions here gone around expanded Galleri studies or future collaborations? Do you have any concerns around the ongoing NHS reform? How is that impacting Galleri and diagnostic aid for cancer conversations?
OPERATOR (Operator)
Thank you. There are no further questions at this time. Ladies and gentlemen, this concludes the call. You may now disconnect.
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