Good day, ladies and gentlemen, and welcome to the GRAIL third 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.
Thank you, and thank you all for joining us today. On the call are Josh Ofman, our Chief Executive Officer, Aaron Freidin, Chief Financial Officer, Sir Harpal Kumar, Chief Scientific Officer and President Global Clinical and Medical Affairs, and Andy Partridge, Chief Growth Officer. I will remind you that we will be making forward-looking statements based on current expectations. It is 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 the federal securities laws. Forward-looking statements are subject to risk 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 document 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 third quarter of 2026. This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit, adjusted gross margin, and adjusted EBITDA, which exclude 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 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.
Thank you. Good afternoon, everyone, and thank you for joining us to review results for the third quarter of 2026 and to discuss recent business updates. GRAIL achieved multiple significant milestones this quarter, including a favorable vote for approval from the FDA's advisory committee and the publication of NHS-Galleri and PATHFINDER 2 results in The New England Journal of Medicine and Nature Medicine. These important clinical and regulatory milestones position us very well as we continue to progress towards future potential regulatory approval and reimbursement. As you know, we submitted our pre-market approval application for Galleri to the FDA in January of this year, and on September 23, the FDA convened an expert advisory committee to consider the safety, effectiveness, and overall benefit-risk profile of Galleri for screening for the early detection of multiple types of cancer in adults age 50 years and older.
Galleri is the first multi-cancer early detection test to undergo FDA review through the PMA pathway, and we were very pleased with the positive vote. The advisory committee discussion highlighted the high evidence bar that GRAIL has set for the entire field of multi-cancer detection tests. We are engaged in interactive communications with the FDA since the advisory committee, and we expect to receive a final decision by early Q1 of 2027. Galleri is supported by a broad evidence base demonstrating its ability to detect cancer signals across over 140 cancer types and subtypes, with a very low false positive rate, and accurately identify cancer signal origin for those positive signals to support an efficient and directed workup. Based on what has now been demonstrated, we believe that adding Galleri to recommended single cancer screens can dramatically improve the effectiveness and the efficiency of national screening programs around the globe.
This is best exemplified by a clear finding from the NHS-Galleri randomized controlled trial. When Galleri was added to standard of care, more than 4x more cancers were identified overall, and Galleri found more Stage 1 and 2 cancers than the entire U.K.'s national screening program found all cancers across all stages. This is remarkable and gives confidence that we can help improve how we screen for cancer and find cancers early before symptoms when there are opportunities for cure. We are very proud of our clinical evidence base, which we believe speaks for itself, and we continue to present and publish our studies in world-leading forums. In September, results from our two largest prospective studies, NHS-Galleri and PATHFINDER 2, were published in The New England Journal of Medicine and Nature Medicine.
These publications build on the results we presented at ASCO earlier this year and demonstrate the many clinically meaningful benefits of Galleri. Across these studies, Galleri has detected over 140 distinct types and subtypes of cancer. We believe the results of the NHS-Galleri trial demonstrated compelling clinical utility. Though we did not observe a combined reduction in Stage 3 and 4 cancers, GRAIL demonstrated the ability to generate a stage shift in cancer detection, producing a clinically meaningful reduction in Stage 4 diagnoses. This is a historic achievement. Performance metrics such as PPV and safety in both the PATHFINDER 2 and NHS-Galleri study were strong and consistent across populations and studies. Together, these studies demonstrate the consistency of GRAIL's performance across two very large screening populations and two unique healthcare systems.
We believe the results provide strong evidence that adding Galleri to standard of care screening can substantially increase the number of cancers identified through screening while maintaining a favorable safety profile. The clinical utility metric of overall cancer detection is compelling, a 4 - 6.5-fold increase in cancer detection through screening, almost half of which are early Stage 1 and 2 cancers, and a 20% reduction in the incidence of Stage 4 disease in a pre-specified group of 12 deadly cancers, a 25% reduction in the emergency room diagnosis of cancer, and of GRAIL-detected cancers at Stage 1 through three, more than 80% were treated with curative intent.
As we await an FDA decision, we are focused on making investments that help us to clearly differentiate GRAIL and reduce much of the noise and confusion that exists in the marketplace, and we are also preparing for engagement with commercial payers and CMS. Turning to commercial performance in 2026, we continued to gain traction and see encouraging levels of volume growth. Test volumes increased 24% in Q3 as compared to the prior year, and to date, we have completed more than 174,000 tests in the first three quarters of the year, an increase of 36% from the prior year. In June, we expanded our provider sales force, and we continue to ramp new personnel toward full productivity as we come out of the summer slowdown. We are also expanding access across provider, health system, employer, and digital channels through new and existing partnerships.
We rolled out our first Epic integration at the end of Q3, and we expect several more integrations through the end of the year. Q3 has typically been a relatively slow quarter, and the effect was compounded this year by the impact in the marketplace related to negative headlines about the NHS-Galleri results, which continued during and after ASCO. Combined with a very active competitive marketplace, this tempered growth in Q3. We expect a potential FDA approval would enable us to clarify the strength of GRAIL's safety and performance data and reinforce that GRAIL is the only FDA-approved MCED test, helping to create a bifurcated market with clear differentiation of GRAIL. After potential FDA approval, GRAIL will stand in a category all on its own. Right now, there is confusion in the marketplace about which MCEDs may be FDA approved.
At this time, all MCEDs are lab-developed tests, but there is a perception that these tests are similar, but of course, they are far from the same. Comparing test performance from small case-controlled studies to large interventional studies in the screening population is simply not scientifically appropriate, and we believe that it is important for the benefits and harms to be understood through interventional studies in the screening population. On the heels of a positive FDA advisory committee and in anticipation of a potential FDA approval, we have started pulling forward our commercial investment, including the sales force expansion, launching our price promotion early, and increased investing in direct-to-consumer advertising. We expect to further increase investment in brand awareness and competitive differentiation going forward as we reshape the market. If we obtain FDA approval, we will clearly differentiate GRAIL as a robust, well-validated FDA-approved test.
Overall, GRAIL has had a very busy quarter. We achieved an important regulatory milestone with the favorable FDA advisory committee vote, we strengthened GRAIL's evidence base through publication of our two landmark clinical studies, and we continued to drive commercial penetration and build the foundation for broad market access. We are well-positioned for continued growth as the clear leader in the MCED field, and we are looking forward to a near-term FDA decision. We are preparing to drive growth acceleration if we receive approval. We believe this milestone will help support advancing engagements with health systems, self-insured employers, payers, and guideline developers, as well as supporting greater conviction among providers and consumers. I'll now hand it over to Aaron for a review of our third quarter financials.
Thanks, Josh, and good afternoon, everyone. In Q3, we reported revenue of $37.5 million, up $1.3 million or 4% as compared to the third quarter of 2025. Total revenue for the third quarter consisted of $37.3 million of screening revenue and $0.2 million of development services revenue. Screening revenue was up 14% as compared with the third quarter of 2025, with test volumes of more than 56,000, an increase of 24% over the third quarter of 2025. Test volumes were moderately lower in Q3 compared to Q2, which is consistent with the seasonality pattern we've observed in Galleri sales since launch, with quarters one and three being relatively soft compared to quarters two and four, and additionally reflects the headwinds we've seen in this market. Overall, Galleri test volume grew 36% over the first nine months of 2026 compared with the same period the prior year.
In parallel, ASPs have come down, resulting in a 24% growth in revenue over the first nine months compared to the year prior. In preparation for an FDA decision and in response to softer growth in the first two months of the quarter, we initiated a pricing promotion in September. We know that price is a significant barrier in the self-pay market, and we expect, as we have seen in the past, that the promotional pricing will generate additional demand. As a result of pricing promotion, our Q3 ASP has come down to approximately $660 a test. We are intentionally prioritizing growth and market penetration over margin optimization in the short term to drive market momentum as we approach an FDA decision and other meaningful milestones. We believe expanding volume grows the experience of providers and patients, provides more opportunity for repeat testing, and drives down COGS over time.
We have long expected that price levels will come down over time to support broad-scale adoption as the MCED legislation ties the price to Cologuard, and the current pricing promotion will provide us with important data to set pricing strategy for the interim period before broad reimbursement. As a reminder, the legacy Illumina royalty, which has been suspended, will resume in late December 2026. In 2026, we have been including in our quarterly filings the calculation for the royalty that would have been paid had it not been suspended. For example, in Q3, we would have paid $2.6 million. In the first quarter of 2027, gross margin will be fully impacted by this royalty for the first time since we spun out as a public company. However, as you know, with our highly automated lab, our gross margins will improve as volumes grow.
We continue to expect adjusted gross margins in the 50%-60% range, including the Illumina royalty at scale. From where we are today, we see approximately a $100 decrease in COGS due to scale as we approach our COGS of about $230, including the royalty. Beyond reductions associated with scale, we have further plans to bring down costs and increase margins, which we look forward to sharing in the future. Continuing with key results for the quarter, net loss for the third quarter was $103.6 million, an increase of 16% as compared to the third quarter of 2025. Non-GAAP adjusted gross profit for the third quarter was $15.9 million, a decrease of $4.1 million, or 20%, as compared with the third quarter of 2025.
Adjusted gross margin of 42% and 46% for the three and nine months ending September 30, 2026, were down from 55% and 49% for the three and nine months ending September 30, 2025. Comparing Q3 2026 to Q3 2025, the decrease in adjusted gross profit and gross margin was primarily driven by higher allocated overhead costs due to changes in sample mix, a reduction in development services, and a reduction in ASP. Adjusted EBITDA for the third quarter was negative $92.6 million, an increase in adjusted EBITDA loss of $20.9 million, or 29%, as compared to the third quarter of 2025. While we are tracking towards achieving our volume growth goals, this volume is coming at a lower ASP.
As we look towards the end of the year, we are updating our guidance for the full year Galleri sales revenue growth to be 17%-21%. We believe that our promotional pricing in late 2026 will set the stage to enable faster growth in 2027 and beyond. Cash burn guidance of no more than $300 million for 2026 remains unchanged. We ended the quarter with a cash position of $788.7 million. Our cash balance today provides runway into 2029 with financial flexibility as we advance key priorities, including our efforts to obtain regulatory approval and reimbursement for Galleri in the U.S. Back to you, Josh.
Thank you, Aaron. Before we open the line for questions, I want to leave you with how we're thinking about the months and years ahead. Our primary focus is on preparing for a world where we achieve regulatory approval and broad reimbursement. This is our strategy to win in the long term, where we look forward to broad population-wide annual screening with Galleri, in addition to recommended single cancer screening tests. We are confident this paradigm can make a dramatic improvement in population health, as cancer is the leading killer of adults over the age of 50. In the near term, we're focused on three key priorities: continuing to interact with the FDA as they evaluate our PMA application, building the foundation for reimbursement, including continuing to further expand our extensive evidence base.
Turning the momentum we're seeing in the market into durable repeat demand as we create a bifurcated MCED marketplace. The positive FDA Advisory Committee vote and the publication of NHS-Galleri and PATHFINDER 2 have earned us the strongest position we have ever had. We are being intentional with our investments in the field and providing a lower promotional price to drive scale and prepare for broad market access. We believe this is the right trade-off for patients and for long-term shareholder value. Galleri is at the beginning of its growth curve, and we've made long-term investments that will enable us to continue to evolve and maintain clear leadership in the multi-cancer early detection field. We believe we stand alone in the rigor and extent of our clinical data and our test performance.
And while the marketplace is becoming increasingly crowded with tests that tout various performance metrics and results, only Galleri has published and presented data showing strong and consistent performance in the actual screening population, our intended use. We are continuing to invest to capture a long-term market where regular annual testing is available and reimbursed. We believe we have identified the strongest biological signal for cancer detection. We have built the most robust data package with strong regulatory and payer engagement and are well-positioned to progress into clinical guidelines. There are more milestones to come, and we're tremendously proud of the progress we've made and our leadership in the field. Multi-cancer early detection has the potential to truly transform the patient experience and reduce metastatic disease across multiple cancers. No other intervention has demonstrated this at population scale.
Based on these latest data readouts, I can now envision a future where we can eradicate the diagnosis of metastatic cancer in our lifetime. None of this would be possible without the participants in our clinical studies, the clinicians and health systems who've put Galleri into practice, and the GRAIL team, whose work over the past 10 years to get us here has simply been extraordinary. On behalf of all of us, thank you. And thank you to our shareholders for your continued support as we work to make early cancer detection part of routine care. With that, operator, let's open the line for questions.
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 will wait one moment to allow the queue to form. Our first question will come from Subbu Nambi with Guggenheim. Please unmute your line and ask your question.
[inaudible], I have an AdCom-related question. At the AdCom, several panelists favored requiring documented shared decision-making, and some raised concerns specifically about digital health platforms. If the final label does require you to have active consent or documented shared decision-making, how would that affect ordering through Hims & Hers function or your own telehealth? Have you had any FDA follow-up questions that touched on this?
Hi, Subbu. Thank you for the question. We actually have not had follow-up FDA questions about that. I think shared decision-making remains something that's very central to clinical care in all aspects and something people expect to happen at all times between the patient and their provider. But no, it's not been raised in our FDA discussions thus far.
Thank you for that, Josh. I know you said related follow-up, but an unrelated follow-up. What are your updated thoughts on pricing and price elasticity for Galleri? Where do you expect to exit 2026 in terms of ASPs, and what's a realistic starting point for 2027 ASPs as you are prioritizing more volume over ASP?
Thank you, Subbu. Aaron, want to go ahead and take that?
Yeah, Subbu, great question. So, as we alluded to, we're leaning into the pricing elasticity, and we saw that this quarter. For 2027, it's too early to say. We'll talk to you about what our ASPs and what volume and all that stuff will look like next year. For the rest of the year, as we said, we really launched into this in September, so the last month of the quarter, and we're on a good track. I'd expect our ASPs to be kind of in line for the year where we are right now.
Got it. Thank you so much, guys.
Our next question will come from Dan Brennan with TD Cowen. Please unmute your line and ask your question.
Great, thank you. Thanks for the questions. Maybe just first one just on FDA. You mentioned early 2027, so I assume that's January. Did FDA give a date? Any color on that? Then, you mentioned you've been in active discussion with FDA. Anything you can share about how the discussion has gone in terms of, is the base case similar to the AdCom, that it would be kind of an all-comers label, and maybe there'd be some language on screen cancer? So anything you can share about what your base case is, how the discussion is going?
Sure. Thank you for the question. Harpal, do you want to-
Yeah. Hi, Dan. Harpal here. I mean, first of all, to say that continued discussions with the FDA, they are very active conversations. Interactions continue to be very positive. We are in very active label negotiations. Look, we are saying early Q1, not going to be more specific than that. We do not have a specific date from the FDA in answer to your question. In terms of the actual label negotiations, we anticipate that the intended use will align with the data that we put forward to support the application, and that will support the broad unmet need for additional cancer screening. As we have said to you before, we anticipate being able to report results for any cancer type we detect.
Great. Then just in terms of the volume and the competitive landscape, looks like Q4 maybe you are thinking somewhere like 20% volume growth, it appears. I am just wondering, have you seen any near-term benefit post the AdCom, and in terms of the ability to turn the tide with FDA approval, just help us think about your ability to distinguish between all the other tests out there with FDA. Is there any hesitancy that you will not be able to dramatically distinguish, even with the approval, given, as you mentioned, the competitive noise factor is pretty high? Thank you.
Thanks, Dan. Andy, you want to take that?
Thanks, Dan. We saw a lot of excitement from our prescribers following the advisory committee. When we actually look at the clinic and health system channel, which, as you know, is our largest business, we actually achieved our volume goals that were set in Q3. We definitely got a tailwind from the advisory committee, combined with the pricing promotion that we executed, that drove a lot of new healthcare provider activation. We saw a lot of reactivation of dormant prescribers, and we have continued to make progress with health systems as well. In market research that we have done with providers, we believe we can differentiate Galleri from the other MCEDs, and when we add an FDA approval into that mix, we are confident we can differentiate our product and achieve that market bifurcation that Josh has described.
Our next question will come from Kyle Mikson with Canaccord Genuity. Please unmute your line and ask your question.
Yeah. Hey, guys. Thanks for the questions. Maybe just continuing on Dan's train of thought there. The fourth quarter, that hopefully will benefit from the AdCom. Third quarter, you talk about how there was some negative sentiment leftover from ASCO. I guess there was other things. You got the Epic maybe tailwind as well. Maybe just talk about anything that you're seeing on those fronts in terms of the Epic or any other partnerships. Then it just feels like maybe we have to wait until this FDA approval in late 1Q for an inflection volume. Maybe just speak to if that's a good way to think about this logically.
Yeah. Thank you, Kyle. I'll comment on that. There is some good momentum now coming out of the AdCom and in anticipation of a potential FDA approval. I'll ask Andy to comment on how he sees that momentum playing forward.
Yeah. Kyle, you'd asked about Epic. We've started our Epic integration now, so we've got our first health system up and running on Epic. We've got a number of health systems that are lined up for the Epic integration, both through the end of this year and into next year. As you know, that's going to enable Galleri to be incorporated into prescribing behavior that happens in health systems. We've got everything lined up for our launch following FDA approval that is going to, as we talked about earlier, differentiate Galleri from other MCEDs. It's going to drive additional health system adoption, we believe, potentially open up guideline discussions. An FDA approval, as we communicated previously, is going to enable us to really start more active engagement with payers going forward in our pursuit, ultimately, of broad reimbursement.
Kyle, just to mention, Kyle, to your point, the approval also provides physicians with a really easy to understand and easy to defend reason to choose Galleri. It really helps the differentiation and creates a class of product where Galleri will stand on its own relative to all the other MCEDs in the market that have scant data and are in their very early development or experimental phases.
Okay. Excellent. Maybe as we get nearer the FDA approval, does that sort of light a fire under CMS to create this policy for an NCD over time. Maybe similarly, there were some media sources indicating that HHS was pushing for USPSTF to include MCED. Maybe can you just comment on any discussions with USPSTF, especially in light of the midterms?
Thanks.
Sure. Hi, Kyle. This is Josh. We can't comment on any discussions with USPSTF. There's a lot of questions still about how that's going to take form or take shape. As it relates to CMS, after the FDA approval, we plan on engaging, as we've already engaged CMS, we plan on engaging them to open their national coverage analysis. We have to await the FDA approval to begin that, but we have been engaging with CMS around our data and around the REACH study all along the way.
Our next question will come from Doug Schenkel with UBS. Please unmute your line and ask your question.
Thank you for taking the question. This is Angela on for Doug. My question is on CE mark and NHS. How are you thinking about the potential timing for CE mark in Europe if you are pursuing that? Specifically for the U.K., how should we think about the path and potential timing to NHS reimbursement following regulatory clearance?
Yeah. Thank you, Angela, for the question. Harpal here. A couple of different points. First of all, with respect to the U.K., we already have regulatory approval. The U.K. has a slightly different system now called the UKCA mark, which we already have, so we don't need to wait for regulatory approval in the U.K. As far as the rest of Europe is concerned, we have submitted for IVDR approval. That process is underway. It typically takes anywhere around 12 months, so we're hoping for a readout sometime in 2027, but that process is well underway. With respect to the NHS, we are continuing to have ongoing conversations. These will be matters that will be affected by overall budget considerations for the NHS, as well as the political environment, if you like.
But we are in active discussions with the NHS, and we will continue to progress those, but I can't give you any sense of timing at this point.
Okay. Thank you for that. Sticking on international, how is the Samsung financing arrangement progressing this quarter, and what commercial activities have you undertaken in those markets to date? That's Korea and Japan.
Yeah, I could start on the financing of this. We closed a $110 million round with them in Q2 of 2026, and that part of the relationship's over. From a commercial perspective, I mean, I hand it over to Andy to say where we're at with them.
Yeah. We've started discussions with Samsung regarding commercialization in Korea, and those discussions are ongoing, and we'll update you further time points as they progress.
Our next question will come from..
Thank you.
Westenberg with Piper Sandler. Please unmute your line and ask your question.
Hey, guys. This is Karan Patel on for David Westenberg. A couple questions here. I guess maybe going back to FDA and possible label restriction. I guess, can you provide any sort of color or guidance into thoughts on an upper bound age restriction, and what share of volume comes from the 65 and above cohort, and then the 50- 65 band as well?
Yeah. Harpal here. Thank you. I can't comment on detailed label negotiations with the FDA at this stage. We are still progressing discussions in line with the data that we submitted to the FDA, which is looking at populations of 50 and above. That's our consideration at the moment. In terms of the split between 50- 65 and 65 and above, I mean, I think that should just reflect the overall population volumes rather than any specific label discussions.
Understood. So maybe population level is reflective of current volumes. A follow-up question is, just anything on sales productivity? I think you guys' reps have kind of reached a steady point. Can you speak about full productivity, et cetera?
Yeah. Go ahead, Andy.
Yeah. I think as we kind of outlined previously, we did expand our sales force from 90 to 120 salespeople in June. That expansion obviously was complete. We are anticipating continued productivity from this team through the end of the year. As I said previously, we actually met our volume goals in that channel where we expanded the sales team, given that team is focused on our clinic business, where we have seen strong new prescriber growth, strong reactivation of dormant prescribers, and strong repeat testing behavior from physicians as well.
Got it. Thank you, guys.
Our next question will come from Robert Bamberger with Baird. Please unmute your line and ask your question.
Hi, guys. This is Josh on for Robbie. Thanks for taking my question. Maybe first on competition, we have seen several peers out with additional advertising campaigns in recent months. Just was wondering if you could walk through how you are thinking about competitive profile here following positive AdCom results. How should we think about sales and marketing growth for Q4 and then also heading into 2027?
Yeah, happy to. As we talked about, we are investing now given the positive AdCom, and we will see that be in line with our plan for the rest of the year. For 2027, we are not done with that plan yet. We will give more guidance later, but I would expect us to be continuing to take advantage of the FDA approval when we get it.
I think we will continue to invest in our commercial marketing and our competitive messaging, and I think the FDA approval, if we should receive it, is going to be quite helpful in helping us continue to differentiate. I think the tactics that we have been deploying in the market now, we are just going to continue to accelerate once we do get the approval.
Great. I think this is the first full quarter that you had the sales force sending out the message on full NHS-Galleri and PATHFINDER 2 results. Just what has feedback been from existing ordering physicians since that has been out there, and how effective has your team been at getting your message to resonate with providers, just given some of the noise that you mentioned earlier in the call?
Yeah. Thanks for the question. The NHS-Galleri and PATHFINDER 2 results are highly differentiating. Galleri is the only product that has been proven to reduce Stage 4. That is a highly compelling message when we deliver that to physicians, and having the full publications now in The New England Journal of Medicine and Nature Medicine, on top of the AdCom and now the pricing promotion, has really generated a lot of excitement in the clinic and health system channels, which was a key driver of why we were able to meet our volume goals for Q3 for that channel, which, as you know, is the largest channel for Galleri.
Our last question will come from Brad Bowers with Mizuho. Please unmute your line and ask your question. You can click star six to unmute your line if you are dialed in by phone.
Can you hear me all right?
Yep, we got you.
Can you hear me all right? All right. Thanks for taking the questions. Appreciate the time. I wanted to hear, we have some analogs now on volume trajectory of screening tests. You alluded to this a bit in the prepared remarks, but FDA is a nice case, but then reimbursement is even more so, and then guidelines. It seems like you kind of share this view, but just wanted to get into how we should, I guess, think about medium-term modeling and kind of the step-ups associated with that.
Yeah. It's Aaron. I'll take a shot at it. I think as Andy alluded to, we're going to be trying, with the FDA approval, we'll be going out to establish a differentiated product to put ourselves separate and so on from the rest of the competition, which I think will help us be in a better position against the market. As far as modeling that growth with an FDA-approved product that's still in a self-pay market, I think that's a little bit more challenging. As I said, as we get to 2027 guidance, we'll give you more detail there. But I feel comfortable saying, comparatively, FDA approval alone versus a reimbursement or a guideline is going to be a lower inflection point, obviously. I'm sure as you'd agree. I don't know, Josh, Andy, anything else you want to add?
No, I would just say that what the FDA approval really provides is the gateway now for coverage and reimbursement. We are going to be dramatically accelerating our engagement with payers and CMS going forward. Now with an FDA-approved product, we have an opportunity. Remember, Medicare, with legislation that was passed this year, can provide coverage for MCEDs that are FDA approved only. So that provides us uniquely that opportunity, which we're going to be pursuing very rigorously going forward. Obviously, we're going to be very active in engaging commercial payers now from this point forward going on. The FDA approval has always been the major gateway for that. Andy, other things you want to add?
I think you really covered it. Josh, as you know, we've built a team that is actively engaging with payers today. We've already had some success with payers, select regional plans like Priority Health and SIHO. Also, Medicare Advantage plans like Alignment and Priority Health have already provided coverage for Galleri. As Josh said, the FDA approval now is going to open up these conversations, not just with regional payers, but also national payers, covering both self-insured employers with ASO plans and Medicare Advantage plans going forward, and we're going to intensify those payer engagement efforts on the back of a potential FDA approval.
That's awesome, Colin. Appreciate that. While we're on the commercial payer conversation, obviously you guys are smart with your pricing, having been out in the market for self-pay and with the pricing promotions bearing fruit this quarter. How do you think, are you going to be able to take that data to the payers? Obviously, patients want lower out-of-pocket costs. The payers will try to figure out where to, I guess, how to optimize volume and price, but obviously want to make sure you guys are getting appropriately paid for the results that you're providing. How are all those things being considered? Thank you.
Yeah, it's part of our plan. That payer team that we've built that are now engaging with payers also work in tandem with our employer team that call on benefits managers for self-insured employers. They've got a whole value proposition and value dossier for GRAIL that includes budget impact models, that they're having conversations with these payers and self-insured employers, all with the goal of expanding coverage and covered lives, given ASO plans for self-insured employers and Medicare Advantage plans are going to be part of our focus going forward, assuming the potential FDA approval that we're in discussions with the agency with right now.
It's still early days, too early to comment on things like cost-sharing requirements or co-pays, but as we dig deeper and engage more thoroughly with all of these regional and national payers, we'll have more to say about that in the future.
Thank you. There are no further questions at this time. Ladies and gentlemen, this concludes the call. You may now disconnect.