Operator
Good afternoon. Thank you for attending the Garden Health Q4 2025 earnings call. My name is Cameron, and I'll be your moderator for today. All lines will be muted during the presentation portion of the call, with an opportunity for questions and answers at the end. If you would like to ask a question, please press star 1 on your telephone keypad. I would now like to pass the conference over to your host, Zarek Kersheed, VP of Investor Relations. May proceed.
Speaker 19
Earlier today, Garden Health released financial results for the quarter and year ended December 31, 2025. Joining me today from Garden are Helene El-Tupi, co-CEO, Amiralee Talasas, co-CEO, and Mike Dell, Chief Financial Officer. Before we begin, I'd like to remind you that during this call, management will make forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items. Additional information regarding material risks and uncertainties, as well as the non-GAAP financial reconciliation to most directly comparable GAAP financial measures are available in the press release garden issued today, as well as in our 10K and other filings with the SEC. GARDEN disclaims any intention or obligation to update or revise financial projections and forward-looking statements, whether because of new information, future events, or otherwise, except as required by law. The information in this conference call is accurate only as of the live broadcast. With that, I would like to turn the call over to Helmi.
Thanks, Eric. Good afternoon, and thank you for joining our fourth quarter and full year 2025 earnings Starting on slide three, 2025 was a breakout year for Gardent, where years of investment continues to fuel breakthrough innovation and best-in-class execution across our portfolio. In oncology, we introduced groundbreaking applications for Gardent 360 liquid, upgraded Gardent 360 tissue onto our smart platform, and expanded Reveal to support therapy monitoring. In screening, we expanded SHIELD to include a multi-cancer detection results report. At the same time, we made significant progress driving adoption across the portfolio. We have seen exceptional growth in our oncology business primarily due to the new capabilities and insights enabled by our smart apps that are increasing both the breadth and depth of ordering of Garden360 more than a decade after its launch. In MRD, we received Medicare coverage for CRC surveillance in early 2025 and growing clinical data generation for review positions as well for additional reimbursement coverage this year. And 2025 represents the first full year for S.H.I.E.L.D. I.V.D., where very meaningful volume and revenue generation exceeds our expectations. We have significantly expanded the commercial team and established impactful strategic partnerships to meet the growing demand for a high-performing blood-based screening option. These advancements reflect our growing execution at scale as we deliver actionable insights to physicians and patients across the care continuum. Importantly, this execution has directly driven strong financial performance, both accelerating our top-line growth and strengthening our path to profitability. Now, I'd like to share a story that illustrates the real-world impact of our tests. A 60-year-old man has gone his entire life without being screened for colorectal cancer, despite repeated recommendations from his physician each year to undergo a colonoscopy. Although he agreed to stool-based testing on several occasions, the kits were never completed once they arrived at his home. During a routine office visit, the patient was offered a shield blood test, which he agreed to, and the test was completed that same day in the office. The shield result was positive, which motivated the patient to undergo his very first colonoscopy, following his physician's recommendation. The colonoscopy identified stage 1 colon cancer, and the patient was quickly scheduled for surgery. Because the cancer was caught early, he has been informed that his treatment is likely curative. The patient expressed deep gratitude for the accessibility and ease of use of the Shield blood-based test, which removed a longstanding barrier to screening and ultimately delivered a life-changing result. Turning to top line performance in slide four, we deliver $281 million of revenue in the fourth quarter, representing 39% year-over-year growth, and $982 million of revenue, or 33% year-over-year growth for the full year. This exceptional performance reflects continued broad-based growth across our oncology screening and biopharma and data businesses. Taking a closer look at our oncology business in slide 5, oncology revenue increased 30% to $190 million and oncology volumes grew 38% to approximately 79,000 tests in the fourth quarter. Turning to slide 6, our smart platform is driving a clear step change in oncology volumes. Garden360 continues to benefit from a consistent rollout of new smart platform applications to survive deeper clinical adoption. Garden 360 tissue gained traction following the major product upgrade released in the second quarter of 2025, and revealed volumes have benefited from Medicare reimbursement for CRC surveillance in the first quarter of 2025. Together, these drivers will continue to catalyze very strong growth in our oncology business. Moving on to slide 7, with each patient tested, our data repository continues to deepen and diversify, bringing together rapidly growing smart epigenetic profiles, multimodal longitudinal data sets, and an expanding set of earlier stage and asymptomatic patient data through Reveal and Shield. This growing data asset is becoming a durable moat. Each additional test compounds the breadth, quality, and uniqueness of our data set, which in turn strengthens the insights we can deliver. By applying our Infinity AI learning engine to this expanding data treasury, We can accelerate therapeutic discovery and biomarker development for our biopharma partners while uncovering new biological insights that reinforce our clinical franchise. The result is a compounding flywheel that steadily increases the clinical utility of our portfolio and expands the impact of where we can deliver to physicians and their patients. We have already applied Infinity AI to develop 15 smart applications on Garden360 Liquid, and we believe these applications meaningfully expand the clinical utility of Garden360 Liquid while further extending our leadership in the liquid CGP market. Looking more closely at some of the recent highlights within our oncology business in slide 8, all of our oncology products contributed meaningfully to our fourth quarter 38% year-over-year growth in volumes, with Garden360 delivering remarkable volume growth of nearly 30% year-over-year. Reveal continues to be our fastest-growing product, reflecting growing demand for tissue-free MRD. We are particularly encouraged by the early uptake of Reveal for late-stage therapy response monitoring launched in the fourth quarter, which is broadening its clinical use. We are advancing the clinical evidence supporting Reveal and recently submitted our chemo monitoring data package to MoldeX for Medicare reimbursement and data from our CDK4-6 monitoring study for publication. We continue to expand in global access in Q4 with the launch of our Garden360 CDX technology with Polyclinico Ginelli, a leading oncology center in Rome, Italy. With approximately 400,000 new malignant tumor cases diagnosed annually across Italy, we are excited to empower oncologists to make more informed treatment decisions for patients with solid tumor cancers. Turning to slide 9 to take a closer look at our revealed data pipeline, we continue to make strong progress in generating and publishing compelling data across multiple cancer types. Based on the Medicare coverage we gained for CRC surveillance, We have now submitted additional data packages to support coverage in breast cancer surveillance, immuno-oncology monitoring, and chemo monitoring. As I just mentioned, we also plan to submit the package for CDK4-6 inhibitor monitoring following the publication. We were encouraged to see data from the largest study of MRD in stage 3 colon cancer published in the Journal of Clinical Oncology, which shows that detecting ctDNA would reveal better predictor occurrence and overall survival than standard imaging. Looking ahead, we have ongoing studies across more than five additional tumor types in both the adjuvant and surveillance settings. Together, the growing body of evidence will continue to strengthen the clinical utility of Reveal and support broader adoption in MRD. Moving on to slide 10, building on our leadership in tissue-free MRD, we launched Gardner Reveal for therapy monitoring in the fourth quarter, expanding the franchise into a significant new opportunity in late-stage cancer. Physicians can now use a simple blood test to gain a real-time molecular review of treatment response and detect disease progression earlier. While still early in the launch, we have been very encouraged by the initial retraction we are seeing. We believe we are building a meaningful, competitive moat in our oncology business through the combined strength of Garden360 and Reveal. Garden is uniquely positioned with scaled offerings spanning both treatment selection and monitoring, enabling a more comprehensive view over the patient journey. This differentiation is driving deeper clinical adoption, supporting more integrated ordering patterns, and creating a natural synergistic dynamic across the oncology franchise. When used together, GARDEN360 and REVEAL enable a seamless approach to therapy selection, monitoring, and retreating across the continuum of care. We are also excited about the potential for therapy monitoring with GARDEN360, highlighted by the results from the AstraZeneca-sponsored Serena 6 trial. This study demonstrated a progression-free survival benefit when late-stage breast cancer patients would switch to camazestrin following the detection of ESR1 mutations in blood. Upon companion diagnostic approval of Garden360, we believe this practice-changing protocol could represent a meaningful driver of test volume. Together, these advances reflect the growing role of blood-based monitoring in cancer care. Shifting gears to our biopharma and data business in slide 11, we delivered another year of strong performance with revenue growing 18 percent year every year to $210 million in 2025. We are a leader in companion diagnostics with 25 approvals to date across the U.S., Japan and Europe, and a robust pipeline of ongoing CDX programs. In the last six months alone, we have announced five new CDX approvals for GARDEN 360, including the U.S. approval last month for the incorapinib combination therapy in patients with BRAF B600E mutant metastatic colorectal cancer, representing the first FDA approval for GARDEN360 and CRC. Our biopharma partner base now includes more than 200 companies, and in January we announced a multi-year agreement with Merck to develop companion diagnostics and commercialized novel therapies. This partnership reflects the growing role of our smart platform across both liquid and tissue in drug development and the strategic value of our platform to biopharma customers. We also made significant progress expanding both the scale and utility of our data set through a series of high-impact partnerships. These collaborations integrate comprehensive EMR records with genomic and epigenomic tumor profiling to accelerate cancer therapy research and development, advance drug response prediction and biomarker insights using multimodal AI, and enable biopharma partners to access EHR and clinical genomic data to support more efficient clinical development of new cancer therapies. With that, I will now turn the call over to Amir Ali for an update on screening.
Speaker 8
Hi, Salmi. Moving on to slide 12, SHIELD has delivered extraordinary growth since launch. It delivered $35 million dollars of SHIELD testing revenue in Q4 driven by approximately 38,000 tests, which was a meaningful step of comfort to 24,000 tests in Q3. Revenue groomed has closely tracked volume growth reflecting ADLT pricing, favorable collections and a disciplined focus on reimbursable lives. Based on performance today, we believe SHIELD is the most successful diagnostic launch in history, outside of COVID testing and its position to be a significant multi-year growth driver for gardens. Now, turning to slide 13 to take a closer look at screening highlights for the fourth quarter of 2025. SHIELD had strong consequential growth in Q4 driven by growing demand from both patients and physicians. Adherence rates remained high, reinforcing the accessibility and convenience of blood-based screening. To support the growing demand, we continue to scale our commercial organization throughout 2025, exiting the year with approximately 300 sales reps. Last month, we received coverage from TRICARE for active duty service members and their families with no Tricare will cover SHIELD for all eligible average risk individuals age 45 and older. In Q4, we launched a dedicated health systems team and we are excited to report that we have successfully deployed our first enterprise scale integrations with large health systems in West Virginia and Georgia. We are excited by the early progress demonstrating the market demand and our ability to operationalize SHIELD within complex health systems including including full EMR integration and workflow deployment. Beyond CRC, we are excited to expand SHIELD to include multi-cancer detection results reported in October. Although still early days, we are encouraged with physicians' enthusiasm to get access to MCD findings and strong interest by patients to be part of the MCD data collection initiative. Turning to slide 14, we are very encouraged by SHIELD's real-world adherence, which reached 93% across the first 100,000 SHIELD tests ordered. In other words, when physicians order SHIELD for CRC screening, 93% of patients completed the test. This represents a meaningful improvement compared to other screening modalities where adherence typically ranges from 25 to 71%. As we illustrated in the patient's story earlier, the ability to complete the SHIELD test During an office visit, removes key barriers and enables far more patients to complete their CRC screening. Taking a closer look at our recent strategic collaborations to scale our commercial infrastructure on slide 15. We are excited to announce collaborations with Quest Diagnostics and Path Group, which will broaden our national reach in 2026. Our collaboration with Quest enables access to their national sales organization and allows providers to order SHIELD and receive results directly through the Quest connectivity system, which was used by approximately 650,000 clinicians and hospital accounts last year. We remain on track to launch this collaboration later this quarter. The tactical collaboration went live in the fourth quarter and expands SHIELD's reach to more than 250 health systems across 25 states. We look forward to seeing the positive impact of our growing commercial infrastructure in 2026 and years to come. Moving on to slide 16. Our goal has always been to detect many cancer types early when they are most treatable. With that in mind, we developed SHIELD as a multi-cancer detection platform. Turning to slide 17. In fourth quarter, we expanded SHIELD to include a multi-cancer results 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 color, which provides tumor-specific information giving more clear guidance to physicians for subsequent diagnostic workouts. The SHIELD MCD report is available to SHIELD CRC patients who opt in and authorize the release of their medical data to Garnet. As a result of this initiative, we expect our SHIELD data repository to grow exponentially and we look forward to leveraging this high-quality data to support reimbursement and regulatory approvals, drive a deeper understanding of clinical utility, and support future technology improvements. We are encouraged to see the recent passage of legislation establishing a Medicare coverage pathway for multi-cancer detection tests. While this is not expected to be a meaningful driver of our business in the near term, we view this as a positive step forward for the field. Turning to slide 18, our outstanding commercial performance in 2025 reflected in rapidly growing revenue was driven by several factors. We achieved ADLT status for SHIELD securing a $1,495 reimbursement rate that supports healthy ASP and gross profit enabling us to reinvest in commercial expansion. We also benefited from meaningful first mover advantage and clear product market fit which drove broad provider adoption, our best-in-class commercial execution, and continued progress with EMR integration, inclusion and NCCN guidelines were additional key contributors to our growth trajectory in 2025. We believe these foundational achievements position shields for continued strong growth Looking more closely at our 2026 setup, the ADLP rate of $1,495 has now been incorporated into the clinical lab reschedule and is secured through December 2027. We also expect to see benefits from our collaboration with Quasun Path Group, alongside the continued expansion of our field force throughout the year. Additional growth drivers include ACS guideline inclusion, targeted direct-to-consumer campaign launches, and the expansion of sales space shield into select market outside the U.S. Turning to slide 19, we continue to invest aggressively in R&D to improve our product performance. As part of that process, we have rigorously evaluated dozens of external technologies over the years. We recently completed the acquisition of Metasite Diagnostics, which brings a new technology in-house that is complementary to the smart platform and also brings on an impressive team further strengthening our world-class R&U organization. We are excited for the technology's potential to enhance our CRC screening, multi-cancer detection, and ultimately the entirety of our oncology product portfolio. It also has the potential to accelerate our multi-disease detection pipeline. With that, I will now turn the call over to Mike for more detail on our financials.
Thanks, Emma, Ali. Turning to slide 20, our review select financial highlights for the quarter and full year ended December 31st, 2025, unless otherwise noted, all growth rates are year over year. Total revenue in the fourth quarter increased 39% to $281.3 million, reflecting strong execution across oncology, biofarmament data and screening. Oncology revenue increased 30% to $189.9 million, driven by continued strong volume growth. We reported approximately 79,000 oncology tests in Q4, up 38%, demonstrating sustained momentum across the portfolio. Garmin360 liquid volumes increased nearly 30%, supported by expanding clinical utility from smart apps launched over the past year, and GARDEN360 tissue remained strong following the major upgrade introduced in Q2. Reveal continued to be our fastest growing oncology product, benefiting from CRC surveillance reimbursement and ongoing strength in breast and lung cancer. We were also encouraged by the early uptake of Reveal for late stage therapy response monitoring launched in Q4. Average selling prices were stable sequentially with GARDEN360 liquid in the range of $3,000 to $3,100, GARDEN360 tissue approximately $2,000 and REVEAL between $600 and $700. As a reminder, we've submitted data packages to MALDEX for Medicare reimbursement covering breast MRD and both immunotherapy and chemotherapy response monitoring. Successful outcomes will provide upside to REVEAL ASP. Biopharma and data revenue was $54.0 million of 9%, which was in line with our expectations. Screening revenue totaled $35.1 million from approximately 38,000 SHIELD tests. SHIELD ASP was approximately $850, consistent with expectations and reflecting our focus on Medicare-covered patients. As of period revenue totaled approximately $18 million for the fourth quarter of 2025, including approximately $3 million related to screening. This was in line with prior periods compared to approximately $17 million in both the third quarter of 2025 and the fourth quarter of 2024. For the full year, total revenue grew 33% to $982.0 million. Oncology revenue increased 26% to $683.6 million. We reported approximately 276,000 oncology tests, representing 34% growth. Garden360 volume growth accelerated to 25% for the year, driven by continued smart app adoption. Garden360 tissue volumes strengthened in the second half following the Smart Platform upgrade and Reveal remained our fastest-growing oncology product throughout the year. Biopharma and data revenue grew 18% to $210.1 million. Finally, screening revenue totalled $79.7 million in our first full calendar year since launch, generated from approximately 87,000 Shield tests. Turning to slide 21. Non-GAAP gross margin improved to 66% in Q4 compared to 63% in the prior year. For the full year, non-GAAP gross margin increased to 66% or from 62% in 2024. This improvement was primarily driven by a significant reduction in revealed cost per test which improved from over $1,000 in Q3 2024 to under $500 throughout 2025. We also made meaningful progress in improving SHIELD gross margins. SHIELD's non-GAAP gross margin improved from negative levels at large to 52% in Q4 2025. This reflects strong ASPs under the Medicare ADLT rate, disciplined focus on reimbursable testing, and continued volume-driven cost reduction. SHIELD cost per test declined sequentially and exited the year at approximately $450 in line with our operational plan. Non-GAAP operating expenses were $260.0 million in Q4, up 21%, and $903.7 million for the full year, up 19%. Full year operating expense was modestly above guidance due to two Q4 items. Firstly, an increase in accrual for the 2025 Company Bonus Plan, which reflects the strong performance in the year across financial, regulatory, and commercial milestones. Secondly, the continued reinvestment of incremental screening gross profit into sales and marketing to accelerate our commercial build-out. Adjusted EBITDA loss improved to $64.9 million in Q4, compared to $78.4 million in the prior For the full year adjusted EBIT our loss improved to $220.9 million versus $257.5 million in 2024. Turning to slide 22. We continue to improve cash performance in 2025. Free cash flow burn was $233 million for the year, an improvement of $42 million and in line with our guidance. Importantly, excluding screening, the core business generated positive free cash flow in both Q3 and Q4. We expect the core business to be free cash flow positive for the full year 2026 and remain committed to achieving company-wide cash flow breakeven by the end of 2027. As Amir Ali mentioned, in December we acquired Metasite for $59 million in upfront cash plus up to 90 million dollars in contingent consideration tied to future commercial and regulatory milestones. We believe this technology enhances our existing product portfolio and accelerates our multi-disease detection pipeline. Following the Metasite acquisition and our November equity and convertible debt financing, we ended the year with approximately 1.3 billion in cash, providing sufficient runway to fund our growth initiatives and reach company-wide cash flow breakeven. Turning to slide 23, we enter 2026 with solid momentum across the business and increasing visibility to our growth drivers. For full year 2026, we expect revenue to be in the range of 1.25 to 1.28 billion dollars, representing growth of 27 to 30 percent. This outlook reflects the same strength in oncology and accelerating expansion in screening, firmly positioning us to achieve our 2028 long-range revenue target of $2.2 billion. We expect oncology revenue growth of 25 to 27 percent in 2026, supported by volume growth of approximately 30 percent. We believe demand fundamentals remain strong across the portfolio. Down in 360 liquid should continue to benefit from adoption of smart apps and down in 360 tissue growth should continue to build on the smart platform upgrade and continue strong commercial execution. Reveal is expected to remain our fastest growing oncology product driven by MRD and therapy monitoring. Note that our oncology guidance does not include potential upsides during the year from Serena 6 ESR1 monitoring, FDA approval of Gardner 360 liquid CDX, and the launch of Reveal Ultra. For BioSharma and DASA, we are encouraged by by recent strategic partnerships and the strength of our CDX pipeline. For 2026, we're forecasting low double-digit revenue growth supported by both ongoing collaborations and new program staff. We expect screening revenue to be in the range of $162 to $174 million, driven by 210,000 to 225,000 tests, a meaningful growth from approximately $80 million revenue and 87,000 tests in 2025. As in 2025, we expect a sequential increase in SHIELD volumes every quarter, with the increases expected to be greater toward the back half of the year. This reflects early year seasonality at PCP offices, the ramping productivity of our growing number of sales reps, and the expansion of EMR capability to our Quest and Path Group collaborations. Note that our screening guidance does not include potential upsides from Quest co-promotion activities, as well as ACS guideline inclusion, which we continue to expect in the near future. We continue to make steady progress improving gross margins across our products through ASP optimization, workflow efficiencies, transition to NovaSeek X, and disciplined cost management. For 2026, we expect non-GAAP gross margin to be in range of 64 to 65%, reflecting ongoing operational improvements, volume growth, and expected product mix. We expect non-GAAP operating expenses of $1.03 to $1.05 billion, representing 14-16% growth year-over-year. We anticipate continued operating leverage as revenue growth outpaces expense growth. R&D and G&A are expected again to remain relatively stable, with incremental investment primarily directed towards screening sales and marketing. Finally, we remain focused on reducing cash burn each year. For 2026, we expect free cash flow burn of $185 to $195 million, an improvement from 2025. Excluding screening, we expect the remainder of the business to be free cash flow positive for the full year. Finally, turning to slide 24. Looking ahead, we have a rich set of catalysts across our business that will drive continued new growth. In oncology, we expect to launch several new products, including GARDEN360 Liquid CDX following FDA approval, our ESR1 monitoring test, and Reveal Ultra. In addition, we expect to release additional apps driven by our smart platform and advance reimbursement across multiple indications for Reveal. In biopharma and data, we expect new CDX approvals as well as additional strategic biopharma and Infinity AI data partnerships. In screening, we look forward to inclusion in ACS guidelines in the near future, driving commercial expansion with Quest, and expanding self-pay shield outside the U.S. With that, we'll now open the call for questions.
Operator
Thank you. We will now begin the Q&A session. If you would like to ask a question, please press star followed by 1 on your telephone keypad. If you'd like to remove your question, press star followed by 2. Again, to ask a question, press star 1. And as a reminder, if you are using a speakerphone, please remember to pick up your handset before asking a question, and we will pause here briefly as questions are registered. The first question comes from the line of Dan Leonard with UBS. May proceed.
Thank you very much. I'd like to talk a little bit about Reveal Therapeutic Monitoring. Helmi, both you and Mike commented on that in your prepared remarks. Could you elaborate further on how you're framing that opportunity both for Reveal volumes as well as for GARDEN 360 volumes as well?
Yeah, we're very excited about Reveal for therapy monitoring. We think it's an important opportunity to really solidify and work synergistically with GARDEN 360. If you think about it, you know, all the volume we have with, you know, 360 patients are being tested in terms of therapy selection, and then, you know, this idea of coupling that with Reveal for essentially monitoring how those patients are doing on therapies is really exciting. And then the nice thing about that is, you know, unfortunately, as some of those patients progress, they're going to need a new therapeutic decision in terms of, you know, hopefully a next-generation drug or a next-line therapy that can be applied to them. And so Reveal for therapy monitoring really bridges to that next Garden360 test. And we have a very unique platform and portfolio that allows these tests to work together. And so I would say that when we get some of the reimbursement wins for IO monitoring and chemo monitoring, this could be a very important driver for growth over the next few years for the oncology business.
The next question comes from the line of Punit Suda with Learink Partners. you may proceed yeah hi guys thanks for taking my questions the first one tell me for you when you look at the strong growth that you've seen in oncology maybe could you elaborate you know how should we think about that throughout the year and both in G 360 versus reveal how should we think about the growth of those products because you know important drivers like the Camus Estran's launch and other things that you've mentioned are actually still not in the guide. So just trying to think about, you know, sort of how should we think about both of these products, you know, volume growth throughout the year.
Jump in. We're very bullish about 26 in terms of the progress we've made in 25 and what we're seeing at the beginning of the year here. So, you know, I would say that we think it's going to be another strong year for 360, You know, something around at least 20% growth in terms of volumes, and then obviously another very strong year for Reveal, but it'll continue to be our fastest growing product. We think we'll see some acceleration obviously with Reveal for therapy monitoring as well and on top of that. So you know, I think we're well underway for our sort of LRP investor day projections in 2028.
Yeah, well, maybe just to add, because we didn't talk about tissue, I think, you know, in the back half of 25, we saw a nice acceleration with tissue following the smart upgrades that we did back in May of last year.
Operator
So I think that also as we look forward in 2026, we think there's, for Garden 360, a pull through about all of Schenkel with Wolf Research you may perceive.
Hi, good afternoon, and thank you for taking my questions, both on S.H.I.E.L.D. and they're related. It's really great to hear that you are expecting to be free cash flow positive in 2026, excluding S.H.I.E.L.D. I'm curious what you're thinking in terms of S.H.I.E.L.D. specific, Byrne. and I think you've provided color on that in the past, and I guess kind of building off of that, I believe you exited 2025 with approximately 300 Shield-focused reps. How should we be thinking about the pacing of rep hiring throughout 2026, and, you know, where do you think the sales force should be at your end? Thank you very much. I'd be honest. That's a good day.
Yeah, yeah, I can start on the question on screening burn, Doug. Yeah, no, for the 25, you know, again, our overall burn for the company was 233 million. Of that, roughly around 220 million was screening, you know, we sort of set a target of 200 million. Actually, we pushed quite hard on that, particularly towards the end of the year. We're really wanting to take advantage of our first mover position. And, you know, we mentioned again on the call that excluding screening the rest of the free cash flow positive. For 26, we think a similar level of on screening is 25. So around that sort of heavy investment.
Speaker 8
In terms of commercial infrastructure and field force, we are very excited with a very powerful commercial platform that we built in 2025. And we are going to continue to build out that commercial organization in 2026. I'm not going to get into the specifics of maybe exact headcounts of the field force, but maybe just to give you some direction and color, the way that you can think about it. We will continue to invest our incremental growth process that we are going to generate this year into further build out of our commercial infrastructure on both sales than marketing, and majority would go still in building Salesforce and hiring more people.
Operator
Great. Thank you very much. The next question comes from the line of Tycho Peterson with Jeffries. You may proceed.
Want to start off on one of the bigger topics on ADLT pricing, what is your latest thinking and what have you baked into the guide, if anything, for G360? And then, you know, overall, you are guiding for a D-cell and volumes and revenue in oncology, presumably some conservatism there. There's a lot you didn't bake in, but where do you think kind of the most conservatism is in the outlook on oncology?
In terms of ADLT, you know, I think we're still on track in terms of FDA submission, making very good progress there. We think that hopefully gets through the finish line in the second half of this year and then, And then, you know, potentially sets up a second sort of a next ADLT pricing rate for 360 at the beginning of 27. So nothing is baked in, in terms of ADLT pricing for 360 for 2026.
In terms of the second part of your question, I would like to ask you about that, I mean, maybe on the volumes, you know, 25 was an incredibly, incredibly strong year, particularly Especially with Garland 360 and just with the smart apps driving the volume. I think we look at 2026 as just continuing that trend. Our guide is 30% on quality volume growth, and so we think that's incredibly strong. And again, that's coming across all of the portfolio, how we mentioned it earlier, but But, you know, we still expect a strong traction with Gardner 360, Reveal being the fastest growing product and continuing to accelerate. So, yeah, I think we're feeling really positive.
Okay, Mike, and then just to follow up, you know, speaking of conservatism, you're also guiding for SHIELD ASPs to be, you know, down relative to where you exited 25, you know, what's the thought process there? And also, what are you baking in for international? I know you flagged that as incremental.
We've really focused on the Medicare population and reimbursable tests. We've done a really great job there, but there is, we are seeing a lot of demand from the under 65s. And so I think, you know, our assumption going into 26 is that that demand will continue to grow and that sort of mix of commercial versus Medicare is just going to increase. So that's really what, you know, we still, you know, we'll maintain the AVL and we're seeing great reimbursement from the international side if the question was.
Operator
The next question comes from the line of Daniel Markowitz with Evercore ISI, you may proceed.
Hey, thanks for taking my question. I wanted to ask on Reveal Ultra, it sounds like that's an area where there's a lot of excitement internally. Can you talk a bit about what will be differentiated about the offering, how you see the tumor-informed competitive landscape evolving, and when we can expect to see some data or a more substantial update on that asset.
Yeah, we're excited about Reveal Ultra, you know, making good progress there. We're on track for launching it this year. And it's something where we believe that the true clinical sensitivity of that test will be best in class. I think there's a lot of, I would say, contrived messaging in this space in terms of different bars that people are using. But we believe that this will, I think, redefine sensitivity in the tumor-informed space. There are other features of the test. It's going to do more than, I think, other tumor-informed offerings. We always have a special sauce at Garden with all our tests in terms of when we launch them. And so, I think I would just say stay tuned as we share more details later this year about that test.
Operator
The next question comes from the line of Andrew Bragman with William Blair. You may proceed.
Hey guys, good afternoon. Thanks for taking the question. Amirly, you sort of talked about the recent MSTED legislation and sort of the longer-term impact there. Can you maybe just sort of broaden out that commentary, talk to us sort of about the importance there for SHIELD in particular? And as you sort of think about the necessary steps regarding to sort of take advantage of that, can you just remind us on sort of the data generation and sort of pass that via approval here?
Speaker 8
Yeah, so as we were talking about this AMSET bill that just passed, so we are, as I mentioned in the prepared remarks, we are encouraged to see the passage of the legislation. It's moving the whole field forward, but it's not going to be a meaningful driver of our business based on a business plan that we have in year term. I think it's good for the field, you know, maybe as we go through mid-term and talking about more than tri-annual testing with Shield, maybe there would be opportunities enabled with this MSET deal for us. But again, in year term, we don't look at it as a meaningful driver of our business.
Operator
The next question comes from the line Osu Bunambi with Guggenheim. You may proceed.
Hey guys, thank you for taking my question. A follow-up to Andrew's question, Amir Ali, what has the opt-in rate for MSET Shield been so far? And if you were to accumulate significant data by year-end, would you be able to submit something to the FDA for MSET approval? I know it doesn't matter to the core story, but just trying to figure out as we think about it.
Speaker 8
Yeah, thanks for this important question. You know, when we are thinking about the data that now we are generating with this MCD offering for SHIELD when the physician patients are opting in. On one side, we are really encouraged by the enthusiasm that we are seeing on the provider side and participation by patients who opt in to release their medical record to us. On the other side, on the data side, I think hopefully in the near future, we would be the company that has access to the widest, broadest clinical data in terms of clinical utility of MCD testing in U.S. patient population. So we're seeing good adoption rate. I don't want to get to the exact number of it. It's trending up, but so far, so good. So far, so good, and we are very excited with it.
Operator
The next question comes from the writer of Michael Reiskin with Bank of America. You may proceed.
Aaron
Analyst — Bank of America
Hey guys, thank you for taking the question. This is Aaron on for Mike. Can you talk a little bit more about the puts and takes of the SHIELD guide? Obviously, Ford, you saw the 14,000 in sequential volume growth. But, you know, should we think about that as more of an anomaly and just kind of thinking about how much conservatism is embedded within the guide? And I guess the second part of that is, you know, thinking about Quest and PATH group, those look like upsides to the guidance, and so, you know, how should we be thinking about the timing of those impacts or those tailwinds as we head through the year? Thank you.
Speaker 8
Yeah, sure. Like, obviously, we are very excited with this guide of, like, 87,000 volume going to midpoint of 217,000 and various used revenue growth and contribution. And, you know, on the other side, when we were thinking about the guide, you know, we are, again, just in the still very early inning of this launch. This is just the second year of launch, and we want to be thoughtful with our guidance. We typically don't want to get too excited and get ahead of our skis just based on one quarter performance. But the trends are very positive. We are, again, very excited of how 2026 is going to shape out for us. In the previous remarks, we talked about, you know, some of the 1Q seasonality and PCP offices. It's kind of normal for us. But again, in terms of year-over-year growth for us, I think we are very excited with the guide that we put out there. And there are some off-site. You'll see, like, you know, we are very optimistic about the ACS guideline, and we believe we should be near her. It's not part of our guide right now until they update their guideline. Quest, Path Group, very minor contribution. We are counting on some benefit of the EMR connectivity enabled through this Quest and Path Group integration, but we are not counting any kind of contribution in terms of the volume contribution of the co-promotion and volume that comes from Quest salespeople. We are going to monitor it. It should be positive, but since we don't know exactly how positive it would be, We want to monitor for the first few months of the launch and see how it goes. And then, if appropriate, we would adjust our guidance accordingly. But we just wanted to be thoughtful about that matter as well.
Operator
The next question comes from the line of Mark Massero with BTIG. You may proceed.
Hey, guys. Thank you for the questions. I wanted to also ask about Shield. So, for Amirly, you know, one of the success stories of one of the drivers of the success of Kologuard was their direct-to-consumer TV launch. How are you thinking about spending in 2026? Is it more select digital or do you anticipate some spend on TV? And then I also wanted to ask about Quest. There is access for, I believe, the Quest salespeople to promote Shield. I just want to double-check that these reps are incentivized. And then can you just maybe give us a sense for where the shield test might sit in their bag relative to the other products they're selling?
Speaker 8
Yeah, so some DTC pilot has actually happened for us in 2025 in select markets. And in 2026, we are excited that hopefully consumers and even physicians would see even more of that. So we have some active campaigns that they are about to get finalized and we are excited to put it out there and see what the impact would be. So we are very excited about it. The rest stay tuned after we launch it in the very near future. In terms of Quest, yeah, actually the salespeople are incentivized. It's part of their commission plan. and what we do know is actually it was very important and interesting for the Quest management team to get access to Shield as a very differentiated brand that gives them opportunity to talk about something new and something exciting with the accounts. So again, we are going to monitor how the launch goes with Quest in terms of co-promotion part of It should be, again, positive, but we'll see how positive it should be.
Operator
The next question comes from the line of Kyle Mixon with Canaccord, you may proceed. Hey, guys, thanks for the questions. On the metasite acquisition, interesting to see that.
Most of the consideration is tied to future commercial performance and the regulatory rules, too, of the technology. So, first one, wondering what the path is to non-cancer launches. And then second, it seems like they use mass spec. How does that fit for NGS-heavy platform?
Speaker 8
Yeah, so we are very actually excited about this acquisition to bring a very high quality world expert on some specific complementary technologies to our smart platform. So we are very excited to go to work and see what we can do. It's a small technology talking again, so let us make more progress and we will talk about it at the right time.
The next question comes from the line of Casey Woodring with JP Morgan. you may perceive great uh thank you for taking my question just a couple more on shield maybe um so you mentioned that the guide is back half weighted what does that guide imply for a shield and one two you know i think that that comment would imply a sizable step down uh sequentially uh and then you know i guess on the acs commentary you made if that hits in the first half of 2026 can you help us think about the upside the volume from the backup of the year and what that could look like? Thank you.
Speaker 8
Yeah, maybe I start with the ACS part. You know, a lot of actually see when it would happen. It should be in the near future. But, you know, I think when you think about our dozen states that they have state-level mandates, that even younger patient populations should get access to the test. And the whole screening market is maybe about 40 percent, you know, this, you know, 65 year and above and more are, in fact, on the younger patient side, that could be an interesting upside and growth driver for us once we start really going much deeper on the commercial testing within those states. But let's first see actually when they update their guideline and we go from there. In terms of Q1, you know, yeah, that's true that, You know, there's some Q1 seasonality in PCP offices, which, you know, in terms of screening and so forth. But our team has done a very good job, you know, to reschedule appointments that have been kind of impacted or the events that have been impacted. And we are on track to screen more patients in Q1 than in any other previous quarters post-launch. So let's see how the rest of the quarter goes. But Andy will talk about it in our next earning call.
Operator
The next question comes from the line of Dan Arias with Steeble. You may proceed.
Good afternoon. This is Paul on for Dan. Thanks for the questions. I guess I just want to follow up on Subu's question about kind of regulatory strategy for multi-cancer shield. One of your competitors had some data out this afternoon with, you know, not meeting a primary endpoint with a very, very large MSED trial in terms of looking for stage shift. And then, you know, one other piece was this week in the New England Journal, there was some FDA willingness to, you know, be a little more flexible on what evidence generation might look like. I'm just wondering if, you know, any of these developments kind of influence what you would look to do for your evidence generation strategy and for your regulatory strategy with Shield MCD.
Speaker 8
Actually, this news just came out, so I don't know all the details of it. We'll be on this call with you guys. but I think when I think about it really what is important in the field of multi-cancer detection is the performance of detecting early stages and we believe with the technology that we have for shield the performance of early stage detection as it's shown in CRC could be very interesting and that could have a meaningful impact. On the other side I think it really highlights what we are doing to capture all the clinical evidence medical record of the patients who are going through mcd testing in us and really establish the utility of this mcd testing at very large scale we are going to benefit from this commercial scale of shield and we can put that you know evidence together in a very you know optics friendly and in a very quick way so i think it's kind of we are getting more bullish with the pathway that we went after screening business on what we are doing with our M-set offer.
Operator
The next question comes from the line of Luke with Barclays. You may proceed.
Great. Thanks for the question. Squeezing me in. So on the shield demand and after you guys have had this for a year and a half now, but this is like the first full year launch. It's been great. You're going to trend even further for next year. Can Can you kind of give us a sense of where the demand is coming from, like how much of this is from the care gap closure versus winning share from colonoscopy or FIT or Cologuard or any of the other tests?
Speaker 8
Yes, so the demand is coming from PCP physician in terms of patient type. Still, we are really focused on on-screened patient population. I think some of the latest data that I've seen about still 90% of the patients who are getting screened by SHIELD have not been screened before at least during the last five years when we got access to their medical record and claims so really our messaging is working and we are increasing the rate of overall screening care gap and you know those kind of opportunities still is ahead of us we need to get you know into we need to qualify for quality scores, and SHIELD still is not, once we get to the HEDIS, that would be a huge additional growth driver for us. So care gap program is not part of our growth right now.
Operator
The next question comes from the line of Jack Meehan with Nefron Research.
Thanks. Good afternoon. Appreciate all the color on the screening investments you're making. I was wondering if you could share color on the oncology side, specifically just the mark-to-market, how large the sales force is there now and planned investments. And then second, you've talked about the NovaSeq X transition. When in the years is that taking place and any way you can quantify level of savings you expect? Thank you.
I think the obvious is Mike said we reached cash flow positivity on the oncology side last year, and obviously we'll be generating cash this year. We're in a really good spot in terms of where we are with Oncology. We've been essentially reinvesting in the business as a matter of course as we see opportunities for growth on the sales side, as we see revenue per rep sort of grow. We saw a tooth around a healthy number in terms of a matter of course expansion of the So we're in a healthy spot, and we'll continue to sort of invest where we see return on investment in terms of potential volume growth. In terms of the NovaSeq transition, maybe I'll let Mike take that one.
You know, we, I mean, first of all, we successfully transitioned the reveal levels, you know, as well as workflow efficiencies. You know, we saw a nice reduction in the cost per test of reveal, and with Garden360, we who started that transition, it will take time to fully be implemented, probably around about the middle of the year, liquid tests to be on Nova CQX. We expect to see a nice improvement in our cost per test, I think, to quantify it a little bit, you know, our gross margin currently for Gartner 360 is in the high 60s. And probably, you know, once we've gone through the full move to NovaSeq X and things are working properly, you know, they expect to see, you know, improvement and Gartner 360 gross margins into the, yeah, no, we're feeling very positive about the switch and it's going to have a nice impact on our P&L. Operator, one more question, please.
Operator
Our last question comes from the line of Bill Bonello with Craig Hallam. You may proceed.
Hey, guys. Thanks a lot for hanging on and taking another question. So this one, I guess, is probably for Helmi. I think that if I understand it right, that FDA approval would open the door to physicians being able to order both tissue and blood from GARDEN concurrently. I'm just curious, you know, what your sense of is for the appetite for using both tests up front and then also touch on maybe any reimbursement challenges that you might anticipate, if that.
Yeah, as you know, guidelines, I think, are increasingly recommending that for patients up front, especially in lung cancer and breast cancer, which are some of our two largest syndications for 360, and one of the challenges is, you know, the way that LDT is reimbursed, you know, it really is not possible to order them concurrently. So that's obviously been a little bit of a headwind that sort of will become a tailwind once we get FDA approval for DARN 360. So we do see that as a potential driver. Obviously, you know, we want to make sure it's done in cases where it's, you know, There's clinical utility for the patients and value for treatment selection. But we're very confident that I think will be an important catalyst for our tissue business going forward.
Operator
Due to the interest of time, that was our last question. That will conclude today's call. Thank you for your participation and enjoy the rest of your day.