All right, great. I think we can get started here. Hi, everybody. My name is Casey Woodring from the Life Science Tools and Diagnostics team here at JP Morgan. Pleased to introduce Guardant Health and the management team of Guardant Health here. We're going to do a presentation followed by Q&A afterwards. Helmy, take it away.
Awesome. Thank you, Casey. Good afternoon, everyone. Thank you for joining us today. Please note our forward-looking statement. At Guardant, everything we do is guided by a simple but ambitious mission to give every person more time free from disease. We began that mission over 10 years ago, pioneering the first liquid biopsy test for cancer therapy selection through countless innovations. We have expanded to help even more patients with our offerings for recurrence monitoring and cancer screening. To date, we have tested over 1 million patients, and our tests have been ordered by over 12,000 oncologists and thousands of primary care physicians. Along the way, we've built a world-class commercial organization, invested approximately $2 billion in R&D to deliver a steady cadence of category-defining products, and established Guardant as a leader in liquid biopsy. Yet, we believe we are still just getting started.
I'd like to begin with a patient story that illustrates the real-world impact of our tests. In 2014, Sarah was diagnosed with HR-positive, HER2-negative breast cancer. She underwent chemotherapy and remained cancer-free for more than a decade. As part of her monitoring in late 2025, she received a Guardant Reveal test, which was positive for ctDNA and provided early evidence of recurrence well before it could have been identified through other methods. Because our tests are all built on the same platform, the physician could simply request a Guardant360 test from the same blood draw, which identified multiple actionable biomarkers, enabling her physician to quickly initiate a targeted therapy. This example highlights the power of our blood-based testing approach. By detecting disease recurrence earlier and delivering actionable molecular insights from a single blood draw, our platform helps quickly guide treatment decisions across the entire cancer journey.
As demonstrated from this example, our tests are designed to work together as a single integrated platform. Today, Guardant is the only liquid biopsy company with offerings that span late-stage cancer therapy selection across both liquid and tissue, MRD, and early cancer detection. Our product portfolio is now powered by our smart platform, which goes far beyond genomics to unlock multimodal biology with proprietary chemistry, advanced algorithms, and AI using our Infinity AI learning engine. This platform is key to our differentiated product portfolio and a robust pipeline of future growth drivers. Turning to our recent performance, 2025 was truly an outstanding year for Guardant. We delivered $280 million of revenue in the fourth quarter, representing 39% year-over-year growth and $981 million of revenue, or 33% year-over-year growth for the full year. Importantly, this performance didn't happen overnight. It built on several years of consistent, strong growth.
What's notable in 2025 is that growth continued to accelerate, which reflects multiple engines across our portfolio. One, strong new product introductions in advanced cancer, meaningful reimbursement progress with the Reveal, and continued strong adoption of Shield in early detection. This broad-based momentum, driven by execution, gives us confidence as we continue to scale the business. We delivered on many major milestones in 2025. In oncology, we made significant progress in therapy selection, including the launch of an upgraded Guardant360 Tissue test and the introduction of multiple new smart applications. We also continued the trend of improving financial execution, including increasing ASPs, expanding gross margins, and tightly managing operating expenses. In MRD, we received reimbursement and CRC surveillance, which drove significant gross margin inflection, and submitted our breast cancer and therapy monitoring data packages to MolDX. We established several strategic biopharma and data partnerships that further strengthened our platform.
In screening, we obtained ADLT status, which improved our Medicare pricing, delivered positive gross margins, advanced our performance with Shield V2 data, and shared compelling multicancer data. Although the American Cancer Society did not update their guidelines last year, we are encouraged by their recent comments at the National Colorectal Cancer Roundtable meeting in November and expect an update in the near future. Our innovation engine is unlocking large new markets, and each breakthrough is building on the last and enabling the next wave of higher-impact applications. Unlike most healthcare companies, our growth is not linear. It compounds through successive S curves, each dramatically expanding the value we deliver to patients, physicians, and the healthcare system. To date, we've unlocked three major S curves: therapy selection, minimal residual disease monitoring, and cancer screening. Looking ahead, Shield is more than just a cancer test.
It is the foundation of a multi-disease detection platform. We are encouraged by early signals that point to future growth in a $300 billion multi-disease screening opportunity. And with that, let's take a closer look at the oncology business. Our oncology portfolio is built on our smart platform and addresses a combined opportunity of roughly $30 billion in the U.S. liquid therapy selection alone comprises roughly one million advanced cancer patients and a $10 billion TAM as the field moves towards multiple tests per patient. Guardant360 Liquid leads the market and continues to gain share through a combination of product innovation and commercial execution. MRD comprises around 18 million patients, representing a TAM of $20 billion, with Guardant Reveal established as the leading tissue-free solution in this space. Together, these represent some of the largest opportunities in oncology.
And we believe Guardant is uniquely positioned to lead across the care continuum. Smart platform innovation is translating directly into oncology volume growth. In 2025, oncology volumes accelerated to 276,000 tests, representing 34% year-over-year growth compared to 20% growth in 2024. That acceleration is being driven not from a single driver, but by a few key factors. The first is a steady cadence of new smart platform applications in Guardant360 Liquid, expanding clinical utility and adoption. Guardant360 grew nearly 30% in the fourth quarter and 25% for the full year, reflecting strong product-market fit. At the same time, Reveal was our fastest-growing product, given its clear leadership in the rapidly expanding tissue-free MRD market. And finally, we're seeing very strong traction with Guardant360 Tissue following the smart platform upgrade and the addition of comprehensive RNA analysis.
Through our Infinity AI learning engine, we are leveraging an expanding data treasury and the power of AI to uncover novel biological signatures and translate them into differentiated products. As our data repository continues to deepen with rapidly growing smart epigenetic profiles, multimodal longitudinal data, and now data from earlier-stage and asymptomatic patients through Shield, we are increasingly excited about the pipeline of products ahead. This data advantage fuels more than just clinical product development. It also is generating new therapeutic insights for our growing biopharma business and enabling commercial intelligence and decision support tools that strengthen our execution. And importantly, this is already delivering results. In a remarkably short amount of time, Infinity AI has powered the launch of over 15 smart apps, with many, many more to come.
And now I'll show you how we're bringing AI directly into how results are delivered, creating a vastly simpler, more intuitive experience that helps physicians make better decisions and ultimately improves patients' outcomes. Today, I'm excited to introduce a new Infinity AI-powered clinical navigation experience. Within our portal, Infinity AI ingests data from across the care ecosystem: multiple Guardant tests, EMR data, pathology reports, and other clinical documents, including scanned and handwritten notes. Instead of asking physicians to sift through multiple reports, each 10 or 20 pages long, Infinity AI brings everything together into a single longitudinal view of the patient, spanning comprehensive profiling, therapy monitoring, and progression. We then layer in treatment history, NCCN guidelines, so clinicians can see clear context and relevant options, not just raw results. And we help guide what comes next, including therapy changes, ongoing monitoring, and MRD after treatment begins.
That's the power of Infinity AI, turning fragmented data into clear, actionable insight and giving physicians a simpler, smarter way to navigate increasingly complex cancer care. In addition, we continue to build a deep and growing body of clinical evidence. Today, our technology is supported by more than 1,200 conference publications and abstracts and over 670 peer-reviewed publications spanning a broad range of cancer types. Recently, we had a very strong presence at San Antonio Breast Cancer Symposium with 17 independent abstracts presented across our oncology portfolio. Turning to MRD, we continue to make strong progress supported by a robust clinical and reimbursement pipeline. Following our success in securing Medicare coverage for CRC surveillance, we recently submitted additional data packages to support coverage in breast cancer surveillance, as well as IO and chemo monitoring, and soon for CDK4/6 inhibitor monitoring.
Looking ahead, we have multiple ongoing studies designed to support indication expansion for Guardant Reveal, spanning both the adjuvant and surveillance settings. Building on our leadership in tissue-free MRD, we were excited to launch Guardant Reveal for therapy monitoring in the fourth quarter. Reveal therapy monitoring expands our tissue-free solution into a large and totally new opportunity in late-stage cancer where there is major unmet need. Rather than waiting for radiographic scans, physicians can now use a simple blood test to gain a real-time molecular view to assess treatment response and to detect disease progression earlier with unprecedented speed and accuracy. When paired with Guardant360 Liquid, this capability creates a seamless system to treat, monitor, and retreat patients.
While still early, we've been very encouraged by the strong initial traction we're seeing with Reveal therapy monitoring and believe this will be a major growth driver for the Reveal franchise in the coming years. We're also seeing promise of a new monitoring application for Guardant360 with a SERENA-6 trial. The AstraZeneca-sponsored study evaluated progression-free survival benefit after switching late-stage breast cancer patients to camizestrant after emergence of an ESR1 mutation was detected in the blood using Guardant360. Once Guardant360 is approved as a companion diagnostic, we believe this new practice-changing protocol could be a meaningful driver of Guardant360 volume in the future. This is a powerful demonstration of the future of cancer care, where therapy is swiftly guided by precise molecular signals rather than delayed by sometimes subjective imaging.
Beyond tissue-free MRD, I'm excited to share an update on Reveal Ultra, our next-generation ultra-sensitive tissue-informed MRD assay capable of achieving clinical sensitivity down to one part per million. As we shared at our investor day in September, Reveal Ultra is built on our smart platform and uniquely combines the strength of both our liquid and tissue technologies. This allows us to push well beyond what's possible with existing approaches. Let me put that into context. What you see here on the plot is the sensitivity ranges of current state-of-the-art tumor-informed MRD testing. Assays built on detection of 16-64, or 256 tumor mutations, often claim ultra-sensitive detection. But in reality, those results are only achievable in contrived cell line samples with unrealistic amounts of input DNA. Even panels with 2,000-plus mutations improve sensitivity, but they still fall short of what is sometimes needed in routine clinical samples.
Reveal Ultra moves the boundary of what's possible in terms of detection. In recent analysis of clinical cohorts across challenging tumor types, Reveal Ultra consistently detected patient recurrences at levels approaching one part per million while maintaining 100% specificity. Importantly, significant percentages of these recurrences were detected at levels well below five parts per million, levels that would be likely missed by existing and emerging tumor-informed MRD assays. That's the difference between theoretical claim sensitivity and true clinically meaningful detection. And today, I'm excited to announce that Guardant Reveal will be launched commercially for use in clinical MRD testing later this year. Shifting gears to our industry-leading biopharma business, which has been a strong revenue contributor and is an important strategic asset for our business.
We had strong performance once again in the biopharma business in 2025 with record revenue and contracted volumes driven by the unique biological insights made available through the power of our smart platform. We are a leader in companion diagnostics with 24 approvals to date across the U.S., Japan, and Europe, with a strong pipeline of ongoing CDx programs. Our partnership with over 200 biopharma customers, including 19 of the top 20 companies, has confirmed the strength we continue to experience. Last year, we established multiple global strategic partnerships with large pharma. We are encouraged by our continued traction in China, where the pipeline continues to grow rapidly, and we have more than 15 partners signed to date. With that, I'll turn it over to AmirAli to share more details on our screening business and to close out the presentation.
Thank you, Helmy. Now, switching to our screening business, where we are the market leader in blood-based CRC screening. Just over one year into commercialization, we are still in very early stages of penetrating a very large unaddressed market. The opportunity is significant with a $50 billion colorectal cancer screening market and more than 54 million unscreened patients in the U.S. alone. This scale underscores both the magnitude of the unmet need and the opportunity for Guardant to deliver meaningful clinical impact and long-term value. From the very beginning, our goal has been to identify and catch many cancer types early when they are most treatable. With that vision in mind, we built Shield from ground up as a multi-cancer detection platform.
We chose CRC as the first screening application because of the attractive balance between the market opportunity and the unmet need to close the gap in CRC screening, while still having a clearly established regulatory and reimbursement pathway, which helps facilitate broad patient access to this lifesaving test. Shield has delivered exceptional growth since launch. In Q4, we delivered approximately 38,000 Shield tests, representing a meaningful step up versus 24,000 tests in the third quarter. Revenue has grown commensurate with volume growth and volume strength as ADLT pricing and a disciplined focus on reimbursable lives has translated into meaningful top-line performance. With this strong performance this year, we believe Shield is the most successful diagnostic launch in history outside COVID testing and will be a significant multi-year growth driver for Guardant.
Shield has strong and fundamental advantages to offer in the fight against cancer and is well-positioned to be the leader in the early cancer detection. Shield is the first and only FDA-approved blood test for primary CRC screening. The blood modality easily integrates into the routine workflow of primary care offices and offers very high patient adherence. Shield was developed by leveraging over a decade of investments and innovations in liquid biopsy at Guardant. This resulted in the best-in-class clinical performance in a pivotal study. The clinical impact of Shield is backed by broad clinical evidence, including randomized studies, which demonstrate that Shield can significantly reduce CRC screening gap. Moreover, our blood-based data repository is a powerful asset that has quickly grown to be the largest of its kind, paving the path for future advancements.
And finally, the multi-cancer detection capability can broaden the clinical value in the fight against cancer. We are very pleased with Shield's real-world adherence level, which was 93% across the first 100,000 patients tested, meaning when the doctors are ordering Shield for CRC screening, 90% of the patients, in fact, complete their test. This is a significant improvement over other modalities with adherence rate ranging between 25%-71%. Now, shifting into our commercial development. Throughout 2025, we expanded our commercial channel significantly and entered 2026 with a sales team of approximately 300 people. We are also excited to announce collaboration with Quest Diagnostics and PathGroup in 2025, which will broaden our national reach in 2026. The Quest Diagnostics collaboration is on track to launch this quarter.
In addition to providing access to Quest Diagnostics national sales organization, providers will be able to order Shield and receive results directly through the Quest Diagnostics connectivity system used by approximately 650,000 clinicians and hospital accounts last year. The PathGroup collaboration went live in the fourth quarter and expanded Shield reach to more than 250 health systems across 25 states. In addition to this collaboration, we continue to invest in scaling our commercial organization to efficiently capture this growing demand. To capture provider and patient attention, we are employing bold messaging across multiple channels, including TV, digital, direct mail, and our influencer campaign. These messages are designed to drive awareness, improve education, and ensure Shield is included in the consideration set when evaluating CRC screening options.
Although we are in early days, the national media attention and third-party media scoring services suggest that these campaigns are performing well and generating positive returns. Our outstanding commercial performance in 2025, as evidenced by quickly ramping revenue for us, was rooted in several key building blocks. We achieved ADLT status, securing a reimbursement rate of $1,495 and providing strong ASP and gross profits to fuel aggressive investments behind scaling the commercial infrastructure. We have a first-mover advantage and strong product-market fit, as evidenced by enthusiasm providers have shown in adopting Shield. Our commercial excellence, our commercial execution, progress with EMR integration, inclusion in NCCN guidelines, all were additional major factors that drove strong performance for us in 2025, now turning to 2026. Very recently, our ADLT rate of $1,495 was included in the new clinical fee schedule and is confirmed for the next two years until December 2027.
Our Medicare Advantage collection is going very well, and we expect to get our first commercial coverage in 2026. We are very much looking forward to additional growth drivers, which include continued expansion of our field force, ACS guideline inclusion, launching our targeted DTC campaigns, Quest and PathGroup collaboration. We are also planning to expand the self-pay Shield in select markets outside the United States. Turning to Shield multi-cancer detection. In the fourth quarter, we expanded Shield to include the multi-cancer findings report, which includes findings for nine of the most common cancers in addition to CRC. With each positive MCD finding, the report includes a cancer site of origin or CSO caller, which provides tumor-specific information, giving more clear guidance to physicians for subsequent diagnostic workup.
The Shield MCD report is available to Shield CRC patients who opt in and authorize the release of their medical data to Guardant. In the first three months of Shield expansion, including the MCD report, feedback on user experience has been very positive, with strong interest by patients to be part of this MCD data collection initiative. As a result of this initiative, our Shield data repository is growing exponentially, and we look forward to leveraging this high-quality medical data to support reimbursement and regulatory approvals, driving a deeper understanding of clinical utility and support future technology improvements. While we are focusing on oncology and cancer screening at this time, Shield is a platform that can expand well beyond oncology and cancer. We have already accumulated a robust database of epigenomic signatures in many diseases in asymptomatic individuals, including liver disease, kidney, cardiovascular, neurodegenerative, and autoimmune diseases.
We are excited about the strength of our pipeline and the vast opportunities ahead. Now, taking a closer look at our financials, we have a strong balance sheet following our recent financing and convertible restructuring and ended this year with approximately $1.3 billion of cash. In 2025, we continued the trend of improving our cash burn each year. Furthermore, excluding screening, we generated positive free cash flow in both Q3 and Q4 of 2025. As a reminder at our Investor Day in September, we pulled forward our long-term profitability guidance by one year, and we now expect to be free cash flow breakeven in Q4 of 2027. Looking ahead, we have a rich set of catalysts across our business that will drive continued growth. In oncology, we expect to launch several new products, including Guardant360 Liquid following FDA approval, our ESR1 monitoring test, Reveal Ultra.
In addition, we expect to release additional apps driven by our smart platform and advanced reimbursement across multiple indications for Reveal. In biopharma and data, we expect new CDx approvals, including SERENA-6, as well as additional strategic biopharma and Infinity AI data partnerships. In screening, we look forward to inclusion in ACS guidelines, driving commercial expansion with Quest and expanding self-pay Shield outside the U.S. With that, I'll turn back over to Casey for Q&A. Thank you.
Great. Thank you. So maybe to kick it off here, Guardant pre-announced a solid top-line beat this morning. Digging into the oncology performance here, you know, you saw 38% year-over-year test growth. Maybe walk us through performance. Did G360 volumes accelerate in the quarter again? How much of that growth was driven by Reveal? It also seems like, based on the volumes you reported, the ASP or maybe the biopharma segment maybe came in a little soft relative to expectations. So just can you unpack the quarter from an oncology standpoint?
Yeah, I'll start, Helmy. Mike, and finish it off. Actually, very similar dynamics to Q3. We're very pleased with the performance. What we saw was Guardant360, as we said in the presentation, grew nearly 30% year-over-year, very strongly. Reveal was our fastest-growing product, and Tissue was in between. So almost exactly the same dynamics as Q3 and, you know, pretty similar top-line growth as well. Really no dynamics. The only difference is maybe some of the seasonality of number of days in Q4 versus number of days in Q3.
Okay.
Yeah.
Well, maybe just to add from the revenue perspective, and obviously, we're still finalizing the numbers, and so we're not breaking them out by the different segments. But yeah, I would say there's no surprises in the revenue numbers. The ASPs came in right in line with how we had expected, how we'd guided. Our biopharma business came in strongly again in Q4, and we ended pretty much in line with our guidance. So yeah, no, it was a great finish for the year from us from a revenue perspective. We're really pleased with the performance.
Okay. And then moving to screening, you know, volumes stepped up there nicely, coming above our estimates in the quarter. Can you walk us through the mix of Medicare versus commercial patients and how this impacted ASPs? And it would also be helpful to hear about ordering trends and the mix of new physicians that are ordering versus, you know, going deeper into existing accounts.
Yeah, still, yes, because we are really focusing on reimbursable cases. The vast, vast majority of the samples that we are processing for Shield are coming from patients at age 65 and above, which are, you know, fee-for-service beneficiaries within the Medicare bucket or MA. Between those two, it's kind of 50/50. In terms of the ordering physician, actually, we continue to see a very healthy and strong increase in breadth of ordering. Like, we are adding a lot of PCPs in each quarter. Having said that, we are just scratching the surface. There are about 250,000 HCPs ordering non-invasive CRC screenings, and still, we are just in very, very early innings of touching, you know, all those kinds of physicians.
Okay. Maybe as a follow-up to that, you know, you launched MCD in 4Q. So curious how that contributed to the volume number for Shield in terms of the number of CRC tests that were run with MCD attached.
Yeah, so we have one Shield test and, you know, one that physicians and patients are opting in. We are providing MCD findings report to them if they are interested. The number that we are reporting are, in fact, the number of CRC cases that we are doing for a fraction that MCD was included. Still, we don't have one full quarter of data for this, you know, MCD attachment, but I can tell you the feedback from both physician and patient has been very strong and very positive. So we'll see how it trends.
Okay. And one last one on the pre-announcement here, then we'll move on. Obviously, a very strong 2025 from a volume perspective with oncology testing growing 34% year-on-year. How should we think about the sustainability of that growth as we think about 2026? And then same thing on Shield. You know, you're exiting the year with a 14,000-ish unit sequential step-up in volumes here. So is that an appropriate cadence for 2026 on a quarterly basis?
Yeah, I guess I would maybe just say that, like, you know, I think we're still standing behind our Investor Day sort of projections in terms of the CAGR over the next few years. And, you know, we have a really nice setup in terms of the oncology business where we're still very much in the early innings of these smart apps that we've launched. There are many more smart apps that are coming.
We have the catalyst of FDA approval, which I didn't talk much about, with Guardant360 Liquid that has been early catalyzed volume by really consolidating the portfolio. ESR1, obviously, monitoring Reveal for monitoring. We're seeing very good traction, I think, with some of those products initially. And yeah, and so, and then obviously, Tissue is still very much in its early innings, and then we have Reveal Ultra as well. So we really don't have a dearth of growth drivers ahead of us. 2026 should be a very strong year.
We are not providing, you know, guidance. You know, we will do it at our 4Q earnings call. But definitely, we are very excited with the exit momentum we are seeing on the Shield and looking forward to see what happens in 2026. You know, as Helmy mentioned, we are even more confident about the long-term targets that we put out there for 2028.
Maybe sticking with oncology, you know, Guardant has attributed the acceleration in G360 Liquid volumes in part to the rollout of smart apps. If you had to pick the top three most impactful and well-received smart apps driving physician excitement, which would those be? And additionally, how much runway do you see for the most recent batch of applications to support sustained volume acceleration there?
Yeah, I mean, one of the ones that's been very exciting is the subtyping application, being able to see essentially the heterogeneity or the subtype of disease like lung cancer. You can see that it's small cell or non-small cell in breast cancer. You can see that it's triple negative or it's changing to HR positive, for instance.
And so seeing really that evolution over time in liquid has been really, I think, exciting to many physicians. We have another one for negative prediction. So being able to confidently call that sample is truly negative, that they're sort of wild-type for KRAS or that there truly isn't a detected molecular alteration that could be actionable. And then, you know, I think pharmacogenomics has been really exciting. The being able to detect cancer of unknown primary and tell you what type of cancer it is has been really another compelling one. There's a surprisingly larger population of sort of unknown primaries out there than people expect. And so that's resonated quite a bit. And yeah, we have a cadence of, you know, dozens of new apps that are in development as well.
Things like epigenotyping, being able to detect, let's say, a fusion using methylation and not detecting it directly with genomics. That is something that will be rolling out soon. And some of the predictive apps, being able to predict immunotherapy or cetuximab or CDK4/6 inhibitors using methylation is also on its way.
Okay. And then, you know, shifting to Reveal, assuming Reveal receives Medicare coverage for breast and IO, how should we think about Reveal ASPs exiting 2026? And would additional indications be needed to reach the long-term target of $1,000? Or would strong execution in breast and IO just be sufficient?
Yeah, I think overall, if we get MolDX reimbursement for breast and in IO and chemo, we'll have a very strong uptick to our ASP. So yeah, you mentioned it, our 2028 target is $1,000. For the last few quarters, we've been sort of $600-$700.
That's really based off CRC reimbursement that we're getting. So I think if we get MolDX reimbursement and we pull through Medicare Advantage and we make some continued progress on the commercial side, then that should be getting us pretty near or at the 1,000 mark. That MA pull-through in commercial, it's going to take more than a year. So I wouldn't expect that at the end of 2026. But I think if we've got those reimbursements from MolDX, we're well on the way to $1,000.
Okay. That's helpful. And then maybe just the last one for oncology and Helmy, then we can shift to screening. But now that the upgraded version of G360 Tissue has been on the market for a few quarters, what trends are you seeing there? Can you provide any color on the attach rate with G360 Liquid, what indications you're seeing the most traction in, and any competitive dynamics that are worth highlighting?
Yeah, it's been very good. We've been very excited by the launch. We've seen very good traction since we launched it in the middle of the year. You know, the dynamics in terms of tumor types actually closely follow what we see with Guardant360 Liquid. So lung is our number one, and it's simpler. Like breast is number two. And it's very similar to Guardant360 Liquid. I would say where we're seeing a lot of traction is the fact that we can use very, very limited amounts of samples. So we can really successfully sort of sequence and report out these samples that tend to be QNS by other approaches.
And so that has been kind of like a very easy entry point for us into the market. And once physicians, you know, see the service, they see the report and the excitement there, then they sort of transition onto the platform. I would say going forward, you know, there's a whole host of smart apps that will be launching on Tissue that I think will further catalyze volume.
Helpful. Maybe AmirAli, you know, you've discussed a future steady-state CRC screening market where at least 20% of all patients will get tested through blood. How do you view the path to reaching this share? Where do you think share could exit 2026? And how might potential ACS guideline inclusion really accelerate that trajectory?
Yeah, so we saw actually after NCCN guideline inclusion, a very nice kind of impact on the growth trajectory and, you know, conversations about Shield was, you know, was positive. It even became even more positive. So when you look at, you know, out of 120 million patients who are eligible for CRC screening, 54 million of them, as I mentioned in the presentation, are unscreened. And there were other modalities in the market, some for 20 years, some for 10 years. And, you know, if we wanted to be able to screen those patients, we would have been better to have been able to screen them really in a very meaningful way. And we've seen in randomized studies that you add Shield as a choice, the rate of screening goes from 45% even to 90%. So that's the promise of adding blood as a choice.
I think, in fact, getting to 20% of the patients getting screened by blood is a very, very reasonable long-term target. All the catalysts like, you know, inclusion by guidelines, ACS, USPSTF, and so forth would be drivers to get to our point, help us to get to that goal.
Maybe the last couple of minutes here. We touched on MCED earlier, but just curious to hear what the strategy is moving forward, particularly how you're going to use the data that you collect to support FDA submissions and any sort of timing on when we can expect those submissions.
It's very exciting. You know, when you look at, you know, if the trends that we are seeing in Q4 continues for us, it's not going to take us long to have a database of, you know, 100,000 patients, U.S. patients that we have access to their Medicare record, and we've been testing them by Shield with MCD result finding. And the value of that database in the real world is going to be very huge to figure out really the real-world performance in terms of sensitivity, specificity of the Shield and the clinical value that it has offered potentially. So this exponential growth of Shield is going to go into the exponential growth of this database that we are capturing. We are very excited with that.
Actually, one more on MCD. What's the plan to introduce pricing here? Will you wait until CMS reimbursement's established? Would you consider launching into the cash pay market similar to other competitors? Sort of what's your thinking on pricing there?
So in the U.S., actually, we are offering at this time MCD result finding as part of our Shield. It's the same test effectively if the physician decides to, you know, get access to it and the patient opts in. Outside the U.S., we are looking into some kind of self-pay opportunities to offer multi-cancer detection capabilities of Shield as a self-pay opportunity. And we see what happens in some of the conversations which are ongoing. As I mentioned, as in our catalyst slide, we think 2026 would be an exciting year for Shield to expand our international business.
Okay. And then maybe last one, we have one minute here. How are you guys thinking about the strength of Guardant's balance sheet? What are your plans for capital deployment moving forward, including the potential for maybe smaller acquisitions to enhance Guardant's tech platform?
Yeah, I mean, we're feeling very comfortable with the balance sheet. You know, we did our equity and convertible financing in November.
As we mentioned in the presentation, we ended the year with $1.3 billion in cash. And just to break that down a little bit more, you know, $500 million of that is earmarked to pre-fund our convertible that matures at the end of 2027. So taking that aside, we've got $800 million in cash. We're reducing our cash burn every year. We're on track to get to free cash flow break-even by Q4 2027. So that $800 is more than sufficient to get us there. So I think it actually gives us some firepower to look at small acquisitions. We've got a very active corporate development team. We do a lot of technology assessments.
So if we identify the right technology that can help differentiate the products, help us drive revenue growth, then I think we feel in a position to be able to do that with the balance sheet that we've got.
Okay. Well, it looks like we'll have to leave it there. Thank you for everybody for attending. Thank you to the Guardant Health team for joining. Enjoy the rest of the conference.