Guardant Health (GH) Q2 2026 earnings call transcript

Thank you. Earlier today, Gardened Health released financial results for the quarter end of June 30th, 2026. Joining me today from Gardened are Co-CEOs Helmio Tuki and Erli Talasas, the Chief Financial Officer of Mike Bell. Before we begin, I'd like to remind you that during this call, we will be making 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-gap financial measures, which are adjusted to exclude certain specified items, additional information regarding material risks and uncertainties, as well as the non-gap financial reconciliation to most directly comparable gap financial measures are available in the press release garden issue today, as well as in our 10Q and other filings with the SEC.

Gardened claims any intention or obligation to update or revise financial projections and forward-looking statements, whether because of new information, feature events or otherwise, except as required by law. The information in this conference call is accurate. Only as is the live broadcast.

With that, I would like to turn the call over to Helmio.

Thanks, Eric. Good afternoon and thank you for joining our second-quarter 2026 earnings call. Starting on slide three, the platform we have built at Gardened is enabling four of the largest opportunities in precision medicine, therapy selection, recurrence monitoring, cancer screening, and ultimately, multi-disease screening. Together, these represent nearly $400 billion in potential markets, all powered by the same smart platform and that compounding technology data and clinical insights to generate across the disease continuum.

Q2 was a landmark quarter in advancing that vision. During the quarter, we received FDA approval for Gardened 360 liquid CDX, as well as approval for a higher throughput lower COB's shield workflow. In addition, we achieved two significant shield milestones, inclusion in the American Cancer Society's colorexial cancer screening guidelines, and just this month, a major coverage decision from UnitedHealth Group. Together with continued broad base growth across the business, these results demonstrate that we are steadily turning our smart platform vision into clinical impact and durable growth.

Before I share our results in more detail, I'd like to share a story that illustrates the real-world impact of our tests. Maria was a 46-year-old mother of two living with metastatic breast cancer. After surgery, chemotherapy, endocrine therapy, and later progression on multiple lines of treatment, her care team pays to familiar but frustrating questions. What next? Her disease had become harder to control.

Issue was limited from prior biopsies and may not be representative of her current disease. In another invasive procedure would have delayed treatment decisions. Her oncologist ordered a Garden 360 liquid test to provide a comprehensive real-time view of her cancer through a blood draw. The results changed the conversation. Garden 360 liquid identified homologous recombination deficiency or HRD, which occurs when cells lose their ability to actively repair double-stranded DNA breaks. Armed with this new biological insight, Maria's care team had greater confidence that her cancer may be more responsive to a DNA damage response strategy as opposed to another empiric chemotherapy. Maria's oncologist shifted her treatment plan to a biomarker-informed approach that included platinum-based therapy, which responded well to with manageable side effects.

Turning to our revenue performance in slide four, we delivered $335 million of revenue in the second quarter, representing 44 percent year-over-year growth. The growth is strong and broad based across our oncology, biopharmine data, and screening business lines. Taking a closer look at our oncology business in slide five, oncology revenue grew 38 percent year-over-year, driving Q2 revenue of $219 million.

Oncology test volumes rose 63 percent to approximately 104,000 tests, up from 64,000 in the prior year period, with strength across all products. Turning to slide six, the tremendous 63 percent growth in oncology volume represented another quarter of acceleration, reflecting the increasing strength of our portfolio across both therapy selection and MRD. Garden 360 liquid year-over-year volume growth accelerated from the first quarter, delivering greater than 30 percent growth, benefiting from continued smart platform adoption.

Garden 360 tissue volume growth also accelerated in the quarter and remains our second fastest growing product. Reveal continues to be our fastest growing product with volume growth accelerating again to more than 100 percent year-over-year, reflecting continued strength in MRD, and growing adoption of the therapy monitoring use case.

Moving to slide seven, I want to spend a moment on what we believe is one of our most under-appreciated assets, our data. Every patient we test, Ethan's a proprietary data asset that is difficult, if not impossible for others to replicate. Today, that repository spans more than 1.3 million patient tests, and over 700,000 epigenetic profiles across more than 102 more types.

This is the raw fuel that powers infinity AI, enabling the discovery of novel biological signatures, the development of new clinically actionable smart apps, and acceleration of drug discovery for our biopharma partners. At ASCO in June, we showcase several innovative new tools built on our infinity AI platform, and we are seeing a very strong positive response.

Turning to slide eight, in May, we received FDA approval for Garden 360 liquid CDS, the most advanced FDA-approved liquid biopsy panel, with 100 times more content versus our legacy FDA-approved CDX product. Garden 360 liquid CDX is significant for several reasons. Most notably, it reinforces Garden's leadership in the field of liquid CGP testing, with Garden 360 liquid CDX representing the only FDA-approved liquid biopsy test incubating both genomic and epigenomic content. Over time, Garden 360 liquid CDX will help to simplify our therapy selection portfolio by consolidating multiple offerings into a single product.

They're also excited by the potential for Garden 360 liquid CDX to complement Garden 360 tissue to drive greater adoption. We remain on track to obtain ADOT designation for Garden 360 liquid phase rollout of Garden 360 liquid CDX to our U. S. customers, and we plan to offer widespread availability of the test following ADOT designation. This approach is intended to ensure a smooth reimbursement transition to the new test. The FDA approval in the second quarter represents one of the most significant regulatory milestones in our company's history, and the feedback from customers thus far has been incredibly strong.

Turning to slide nine, reveal continues to perform at an extremely high level with volume growth accelerating for the third quarter in a row, to well above 100% year over year. We believe reveal remains the most validated and highest performing tissue-free MRD solution with a five-day turnaround time. Once again, we experience strong MRD uptake in the second quarter across major indications, and reveal therapy monitoring continues to stand out as a major volume growth driver in its second full quarter after launch. Reveal is uniquely suited for therapy monitoring late stage cancer, helping predict therapy response months before energy, and with seamless connectivity to Garden 360 liquid, it can help physicians to act sooner and with more precision.

Late stage cancer therapy monitoring alone is a multi-million test annual opportunity that remains largely untapped. We continue to be excited about the commercial momentum behind reveal, and we remain on track to launch reveal ultra later this year, which we believe will be the most sensitive tumor-informed MRD test.

Turning to slide 10, we continue to make progress advancing our reveal data and publication pipeline. As a reminder, we have submitted data to MOLVX for coverage for best cancer surveillance, immuno-oncology monitoring, and chemotherapy monitoring, and those initiatives continue to progress.

Shifting to our biopharmored data business in slide 11, revenue grew 9% year over year to $61 million, which marks the record quarter. Our companion diagnostic franchise continues to build momentum. We now have 28 CDX approvals with four added in the first half of this year alone. This reflects the strategic value for a smart platform to leading biopharmored companies. During the quarter, we received FDA approval for Garden 360 CDX as a companion diagnostic for Borender Engleheims for Nexios, the first target therapy approved for adults with HER2 or ERVBB2 mutant advanced non-smell cell lung cancer as an initial treatment option. We also received FDA approval for Garden 360 CDX as a companion diagnostic for our Venus and Pfizer's Papano for ER positive HER2-negative ES01 mutated advanced breast cancer.

We also announced a collaboration with New Vailant to develop companion diagnostics with an initial focus on Garden 360 tissue. With that, I'll now turn the call over to Mira Lee for an update on screening.

Thank you, Helmi. Moving on to slide 12. We developed SHIELD from the ground up as a multi-cancer detection platform. SHIELD is clinically validated for detection of 10 different cancer types and is approved by the FDA for colorectal cancer screening as its first indication. When a physician orders a SHIELD blood test for CRC screening, they can opt in to receive multi-cancer detection results report covering nine additional cancer types beyond CRC. The release of this report is contingent on patients authorizing the release of their medical records to Garden as part of our data collection initiative. You're very pleased with the progress in multi-cancer data collection and are excited to see the majority of SHIELD ordering physicians opting in to receive MCD reports.

With colorectal cancer screening still representing such a significant unmet need, CRC remains our primary commercial focus. Now, moving on to the slide 13 for an update on this screening business. Due to what's another fantastic quarter for SHIELD, we delivered $53 million of SHIELD testing revenue driven by our Parkinson's 56,000 tests, compared to $15 million of revenue on our Parkinson's 56,000 tests in Q12 2025.

Turning to slide 14, we chose the evolution of SHIELD sales over the last eight quarters overlaid with the important guidelines, commercial partnerships and coverage wins that have been instrumental in driving recent demand and that gives us confidence in future growth. I will discuss a few of these significant wins in greater detail shortly. We are now well into our second year of commercial launch and the business continues to fire on all cylinders.

Moving on to slide 15 to discuss our major screening highlights. We saw exceptionally strong volume growth in the quarter, driven by commercial scale, DTC momentum and our Quest collaboration.

SHIELD was included in the American Cancer Society's colorectal cancer screening guidelines making SHIELD the only FDA approved blood tests included in both ACS and NCCN guidelines.

And United Health Group, the largest commercial insurer in the United States, announced it will begin covering SHIELD for colorectal cancer screening in adults 45 and older.

Moreover, we are excited to report that last week we received FDA approval for a higher throughput lower COG SHIELD workflow. Let's focus on the latest scale SHIELD commercial engine on slide 16. SHIELD's commercial reach continues to expand rapidly on personal promotion, campaign, health system engagements and EMR connectivity. We are happy to report that our field organization now stands at over 400 professionals nationwide. In addition to our internal sales team, the Quest collaboration has been a success. We are encouraged with how nationwide EMR access and coloremational activities with their team have developed in the first full quarter since the relationship went live in the field. In addition to these initiatives, we have built and expanded our dedicated health system team to more than 30 people and have been encouraged by the engagement within large accounts.

Turning to slide 17, patient access to SHIELD blood test continues to expand at a rapid rate. SHIELD was added to the NCCM guidelines in June 2025 and to the American Cancer Society guidelines in May 2026. ACS guidelines inclusion is particularly important because it triggers state level coverage mandates in roughly a dozen states for commercial payers.

An exciting result of these guidelines wins has been positive momentum in our payer discussion and is sooner than expected United Health coverage policy update that I mentioned earlier. This coverage will be effective starting on August 1st, which includes SHIELD as a covered primary colorectal cancer screening option for average risk adults age 45 and older. United Health is the largest commercial insurer in the US and the first major insurer to cover SHIELD.

Turning to slide 18 to put these commercial coverage wins into context. There are approximately 120 million average risk individuals in US eligible for colorectal cancer screening, representing a $50 billion US addressable screening market. As a result of ACS guidelines inclusion and the United Health coverage policy, we believe that approximately 70 million lives or roughly 60% of the market is now covered for SHIELD blood tests.

Turning to slide 19. Last week, we received STF approval for a higher throughput lower cost SHIELD workflow. And that workflow will be live in production in August for all new incoming samples. This workflow improvement will increase efficiency in running the test and will reduce the cost per test. Furthermore, it will improve the scalability of our existing lab operations.

As a result of this development, the much stronger than expected demand and the United Health coverage news, we are accelerating investments to continue to build our lab capacity ahead of rapidly increasing volume. We are excited about all the progress across multiple front-side guard and health. On behalf of Hellman myself, I want to express our detailed gratitude to our leaders and the whole guard and team, watching this team's focus, integrity and shared education to our mission, continues to inspire us both every single day.

With that, I'll turn the call over to Mike for more detail on our financials.

Thanks, Amirale. Turning to slide 20. I'll walk to our second quarter results, unless otherwise noted, growth rates a year over year. Second quarter revenue reached $335 million of 44%. Growth was broad-based with strong contributions from oncology, biopharmoring data and screening. Oncology revenue was $219 million and increase of 38%. Oncology test volume grew 63% to approximately 104,000 tests, reflecting strength across the portfolio. Within the portfolio, garden 360 liquid volume increased more than 30%, driven by continued adoption of our smart apps.

Garden 360 tissue accelerated from first quarter levels and remained our second fastest growing oncology product, reflecting the product enhancements introduced over the past few quarters. Reveal again led the portfolio in growth, with volume more than doubling year over year, as MRD adoption expanded and therapy response monitoring contributed meaningfully. Oncology ASPs were broadly stable sequentially and are submissions to MOLDX for Medicare reimbursement covering breast MRD and immunotherapy and chemotherapy response monitoring continue to progress.

Our biopharmoring data business delivered record quarterly revenue of $61 million of 9%, reflecting the increasing strategic value of our smart platform and infinity AI offerings to biopharm partners. Screening revenue was $53 million compared to 15 million a year ago. Shield volume increased to approximately 66,000 tests from 16,000 a year ago. ASP was approximately $800 per test, with reimbursement remaining strong across Medicare fee for service and Medicare advantage. As expected, the mix of commercially insured patients under age 65 increased in the coverage, with Shield now included in ACS guidelines and United Healthcare coverage beginning in August, we expect the commercial mix to continue to increase in the second half of the year.

Turning to slide 21, Zamir Ali noted that the FDA recently approved a higher throughput lower COG's Shield workflow. This marks a significant step forward in our efforts to reduce Shield cost per test. When fully implemented in our lab operations, the new workflow will produce a step down in Shield cost per test. Combined with additional efficiencies from increasing scale, we expect that by the end of 2026, Shield cost per test will reduce by roughly 15% from the current level of approximately $410. Beyond 2026, further scale benefits and major automation initiatives are expected to drive the next wave of reductions and support our $200 cost per test target in 2028.

Turning to slide 22, second quarter of non gap gross margin was 67% compared with 66% a year ago. The improvement reflects lab efficiency, discipline execution and tight cost control. As planned, we completed the Gardener 360 liquid transition to Novosik X in May, reducing cost per test by approximately $200. That benefit, together with the planned Shield cost reductions will help support continued strong gross margins in the second half, even as our product mix continues to evolve. Non gap operating expenses were $28 million, up 34%. With the increase concentrated in commercial investment, sales and marketing expense was $172 million compared with 108 million a year ago. As we continue to expand the screening sales infrastructure, advanced Shield HCP and DTC programs and supported oncology growth.

Adjusted EBITDA loss was $56 million, compared with a loss of $52 million in the second quarter of 2025. Quarter end cash investments were approximately $1.2 billion, and free cash flow burned in Q2 was $70 million, compared with 66 million a year ago. The year of the year increase was due to additional capex investment in screening lab automation and broader infrastructure to support higher test volumes, greater processing efficiency and improved turnaround times.

Turning to slide 23, our first half results and the progress since our last call give us greater visibility into the bounce of the year. We are raising full year 2026 revenue guidance to a range of $1.34 billion to $1.36 billion, representing growth of 36 to 38%. For oncology, we now expect revenue growth of approximately 30% and volume growth of approximately 50%. The outlook reflects continued smart app adoption of Garden 360 liquid, strong commercial execution and the impact of recent product upgrades in Garden 360 tissue, as well as continued growth in reveal across MRD and therapy monitoring. Our bio farmer and data outlook is then changed at low double digit growth, supported by recent strategic partnerships and continued good progress across the companion diagnostic pipeline.

For screening, we are raising revenue guidance to a range of $218 million. To $230 million and now expect $270,000 to 285,000 shield tests. The higher outlook reflects strong demand and commercial execution, as well as greater confidence following ACS guideline inclusion and United help coverage, which becomes effective in August. Our full year non gap growth margin outlook remains 64 to 65%. The range incorporates lower testing costs for Garden 360 liquid and in the second half, partially offset by product mix as shields and reveal volumes scale.

We intend to continue to reinvest incremental screening growth profits to support commercial expansion. As a result, we now expect 2026 non gap operating expenses of $1.08 billion to $1.1 billion representing growth of 20 to 22% compared with 2025. We now expect full year free cash flow burn of $195 to $205 million, $10 million above our prior outlook and an improvement compared with 2025. As mentioned, this revision reflects CAPEX investments to accelerate the expansion of shields lab capacity, supporting anticipated growth over the next several years.

We continue to expect the rest of the business excluding screening to generate positive free cash flow in 2026, with year of year improvement in cash generation, and we remain committed to achieving company-wide cash flow break even by the end of 2027.

Turning to slide 24, several catalysts we discussed last quarter in now in hand. In oncology, the Nova Cx transition is complete and Garden 360 liquid CDX is FDA approved. Our priorities are continued expansion of smart platform apps, the larger reveal ultra and broader reveal reimbursement. The ESL One Monitoring Launch remains contingent on FDA approval of Kamisestrunt. In biopharma and data, our priorities are to continue to advance CDX programs, broaden strategic partnerships, and scale infinity AI. In screening, we obtained ACS guideline inclusion and are excited about the selection of shield. We're also expanding shield internationally through our self-paid channel.

To close, Q2 demonstrates the breadth of our growth and the progress we're making in driving efficiencies across our operations. We are investing in the areas with the greatest long-term potential or maintaining our commitment to cash flow break even.

With that, we'll open the call for questions.

Thank you, Kyle. You know, obviously, we are very excited about this recent development. We built ACS and United Health coverage, as I mentioned, a pre-prepared remark actually now. Roughly 70 million lives are covered for Shield 60% of the whole market.

This UHG win could actually give us some interesting benefits. Like, we are excited to see how the rest of the year would play out. You know, it could be a tailwind for the volume. It would help us to strategically step-by-step build our commercial side of the volume, so not just 65 and above, but actually younger patients and make sure they get access to this breakthrough technology.

ASB is going to take some time, though, like, you know, ASB in order to see the impact. We need to obviously go through some kind of conversations with them, but also show the history of collection from them in order to be able to accrue some of the upside up funds. So on ASB side, we need to be more patient. USGSDS, it's our expectations as it was before. So looks like new members are going to be in place. Looks like the August meeting is going to happen, but in terms of our expectations, we are not changing anything. So we are monitoring to see what happens. It's interesting, as I mentioned, that some of the payers, even before USGSDS, are engaging in conversations with us, and we'll see what happens.

Thanks, Subu, for the good question. Yeah, we're really excited about what we saw in the quarter in terms of oncology volumes. Obviously, that a tremendous sort of volume ramp that we saw. And it was really broad base in terms of the beat. We saw great volumes from 360 growing, you know, over 30% year over year. Tissue continued to accelerate, you know, with higher percent. And, you know, and so I think all of them are really going to be contributing to sort of continued strong volume for the second half of the year. And, you know, obviously, we have strong sort of comps for Q3 and Q4 for 360. But I think we're very confident that we can continue the momentum we're seeing, you know, at least in the first half of the year on all of the products going forward.

And so then we can hit that 50% mark that we guided to. I don't know if Mike wants to add.

I mean, no, just to reiterate how we went, you know, I think our guide now of 50%, you know, full year oncology, volume growth is incredibly strong. So, yeah, I mean, we have, I think we have tough comps now every every quarter. So we'll continue to manage that. But I think, you know, our guide, again, for Q3 and Q4 is implying very strong oncology, volume growth.

We learned United's health, you know, it was unexpected for us too. It was much sooner than what besides kind of happened. Having said that, you know, we have multi-year relationship with United because of our oncology products and coverage is we have the relationship and we had multi-year conversation with United about the value of the shield and what it could offer.

There's also something in the hair landscape that nobody want to be first, nobody want to be last. So again, still we we don't expect any major wins in short term by any other major appears. Having said that, you know, again, nobody want to be last too. And we are excited with some of the conversations that we are having with some plants. We see what happens. A lot will happen.

Thanks for the question, Puneet. You know, we're very excited about what we're seeing. And it's, you know, what we obviously built the product to and how advanced we believe it is compared to sort of the landscape right now in the liquid biopsy market. It really is one of the most comprehensive tests out there. It covers broadly all the genomic markers of relevance, but really the only test that has integrated genome-wide methylation coverage, which is really driving a lot of the, I think, really exciting sort of next-gen applications of liquid biopsy. And frankly, I think we're just scratching the surface in terms of what's possible with this platform. And I think, you know, many physicians are just starting to get sort of the experience of using it with patients.

And it's, you know, when you get those hits, you know, when you find something that you couldn't find before, you find an option for a patient, it takes time to sort of get those experiences. And I think we're really leaning into it now, now that it's been on the market for a few quarters. And we're very excited about the pipeline in terms of other apps that we have a kind of involvement that will be coming out soon. So we think this is something that we can continue to lean into, not just for the sort of one test per patient era that we're in right now, but when we started thinking about patients using a liquid biopsy, a garden 360 test at every progression.

And that's still not something we've leaned into. That's a big market multiplier. And why we believe we can continue to sort of lean in to this growth of 360 for years to come.

Regarding our... There was something about ShieldMate quickly to answer that, you know, the sequential growth of Q2 over Q1 was super strong for us. 22,000, you know, multiple factors that compounded at once. You know, we launched this Quest Pro-Motion, we launched our DTC, you know, we are adding to our field force. And there's some non-linear effects that we are seeing, you know, that, you know, the productivity of our reps have gone up in a very interesting way when we are doing the Pro-Motion with Quest and we have, you know, our DTC in the air.

There were multiple factors all combined between Q2 and Q1, so we don't expect multiple new things all heating at once in Q3. Having said that, you know, we are very excited of what we can do in the second half, like we increased our guide by 4D,000 samples, which translates as a midpoint, the guide that we put out there, like sequential growth of 12,000 Q over Q. We don't want to get ahead of our skis, we have the fantastic Q2 results that we have for the rest of the year, and we're very thoughtful. I think it's a very reasonable guide for a section half of the year for us.

Yes, so in terms of pricing negotiation, like, you know, we just got the coverage, so let's go through that process and see what's going to happen. You know, it's very typical diagnostics, Medicare pricing is a centerpiece of conversations and our pricing is very transparent to everybody, you know, when they make it undercover's decision. So, but we'll see how it goes.

In terms of the risking, I think, you know, United Health decided to act before USPFTF, and we are seeing some additional conversations with other players. Definitely, we are getting the attention, United Health coverage decision is getting the attention by other people. Our progress in the field in terms of the impact we are showing is getting the attention. We have a scale team in managed care team that have all the connections and relationships, and we've bunched up to those people. We have multi-year conversations about SHIELD. But again, we'll see how it goes. We don't expect any major wins, you know, for the year we haven't included anything in our guide in terms of additional wins. We'll see how it goes.

No, you know, I think we're going through the ADLT process now. You know, we were expecting a price of 84, 55. And so, you know, that will be that will be an uplift from our current Medicare price of $5,000. And then, you know, that would be that would be an immediate increase. It'll take time for Medicare advantage and commercial payers to sort of change the price in line with the new Medicare price. And I think, you know, we've seen that in the past when Ghana 360 CDX to ADLT and ADLT pricing, you know, it can take sort of 12 to 24 months for that to flow through. So, you know, I would expect once we get that ADLT, yeah, we'll see a nice uptake, you know, for all those people Ghana 360, but then it should continue to improve over again the next sort of 12 to 18 months.

Yeah. Investing the incremental gross profit. I think, you know, that's we've been sort of doing that over the past sort of 12 to 18 months on the screen, on the screening side of business. And that's been allowing us to increase our investment specifically on the commercial side. I think we're oncology, you know, if and when we do get a higher ASP and incremental gross profit, we will allow some of that to drop down to the bottom line. I think, you know, we've said it many times, but we're very focused on getting to cash flow breakeven as quickly as possible. And so, you know, that could give us the ability to accelerate our timeline, which is, you know, currently sort of Q4, 2027.

But we'd also want to take some of that gross profit and reinvest it back in the business, you know, I mean, we continue to be a company of innovation. I think we'd want to continue to do that. But we could, you know, we would also on the oncology side of the business one to continue to invest on the commercial operation. So I think, you know, hopefully we'll be able to do both. And it'll start to, you know, we'll start to have a very nice P&L as and when that comes.

Yeah, I'll take that. Again, just to sort of reiterate, at our investor day last year, we sort of increased our 2028 revenue target. It would have previously been 2 billion. And we increased that to 2.2 billion, which sort of inferred a growth rate over three years of just over 30%. So I would say that so far so good, I think we do very well against that. Our current guide is now for the full year of 26 is 36 to 38%. So I think against what we need to do over that three-year period, we do it very well. I don't think we're in a position to sort of change that target now, but I think where we are in the middle of 26 just gives us a lot more confidence that we can achieve that 2.2 billion.

I think the other question was related to the would that lead to a garden 360 ASP of around $5,000? That's probably in the ballpark on a sort of a long term. I just mentioned on the last answer, it would probably take 12, 18, 24 months to sort of get to that level. But realizing overall, a sort of 60% of the Medicare rate, that's currently where we are with garden 360. So I think that's sort of like $5,000 level is achievable.

And I think basically on the profitability, the incremental growth profit and how we would manage that, I think we talked about that on the last question with Dan. And again, I think it would be a mix of letting that drop down, some of that drop down to the bottom line, hopefully accelerating our path to break human, but also reinvesting back in the business in innovation and on the commercial strength of the company.

Yeah, great questions, Casey. We're very excited about what we're saying with therapy monitoring. I mean, that said, we're saying really good traction with MRD and with our veal volumes. And but, you know, therapy monitoring, I think is a let's say maybe under appreciated opportunity in the market. This is, I think, the future of oncology in terms of moving from biopsies and scams to really just using blood quantitatively to both treat and monitor patient response to therapy. So we're seeing very, very good uptake from our G360 orders who really want to sort of move into the future of precision medicine here. And yeah, and we think this is a great leading indicator for some of the sort of reimbursement over the finish line.

It's going to be a very, very strong business for us. If you think about it, there are a million late stage patients. It's a multi multi-million sort of testing opportunity there just for therapy monitoring. If you think about monitoring those patients a couple times during each course or each line of therapy. And so I think it's could be, you know, I think nearly as big as maybe even the MRD opportunity testing point of view, at least in the active cancer patient segment. And then in terms of FDA approval, it really happened sort of late in the quarter. So I think, you know, very early to sort of comment on it. And because we were doing a phased launch, yeah, it's having a positive impact, but nothing, I think it won't be as big of an impact as when we finally sort of do a full launch once we get ADLP designation.

But certainly we're seeing a lot of positive reception, a lot of excitement from physicians. And it's certainly something that we're going to lean into in the quarters.

Yeah, yes. In terms of reveal, Ultra, it's a highly competitive market. So I think we're keeping some things close to the chest here in terms of exactly how we're going to launch it and what indications. But I can tell you that the development has gone really, really well in terms of the performance we're seeing. We're routinely hitting LOD levels of low below one parts per million.

And in real samples, it's really exciting to see the potential there. I mean, that is detecting sort of tumors and early cancer at really unprecedented levels to be able to go that deep. And it's going to be really, I think, we're very sensitive to how the product sort of fits with the rest of the portfolio. We want to really make sure that it's sort of seamless in terms of the connectivity between reveal, between Garden 360 and between our tissue products. And so we're going to be very thoughtful in terms of how we launch it and which indications we launch it where we believe we can sort of have the sort of greatest traction early on.

And then also, I think, focused on thinking about the sort of reimbursement timelines there, the roadmap, some of the clinical validation as well. So that's a lot of the work we're doing there.

Regarding shield multicancer, data collection is going very well, powered really by the attachment rate that remains very strong. And I mentioned that majority of physician ordering shield now are opting in to receive density results reports. So we are very happy with what we are saying.

So actually, we have to see what the United conversation would be around the co-pay and the patient responsibility. So we see how it goes, but obviously, if we post you guys, we see if there's any co-pay, that's a good go away.

And about the rebates, I don't have any comments to share at this time.

Well, so you know, obviously, it's the same customer base in terms of the same on colleges that are ordering both tests and the two really sit and in glove in the sense that you first test the patients to determine what therapy may be best for them. And then you typically want to see how are they doing in that therapy. And so it's a nice one, two punch in terms of how the products fit together. And I think it is not only, I think, sort of a very strong introduction for us in terms of the utility of the product. You can do some things that I think other products in the field can't do. But I think it also creates a nice data stream for physicians where essentially you want to see the longitudinal view of every single patient through every line of treatment, through every progression.

And so it's really, I think, leaning into this platformization concept that we talked about a couple of years ago introducing the field. And this is really, I think, making that vision a reality now.

Yeah, and that's a great question. I mean, we don't have, I would say much baked in, given the phased rollout, but we certainly are very excited for the potential for that once we get ADLP designation, and we have a sort of more complete rollout of the CDX. That said, I think we're very excited by the traction we're making with garden 360 tissue. It's our second fastest growing product on the oncology side. We saw acceleration this last quarter. And I think, really starting to gain traction as more physicians realize some of the advantages that tissue has. We're seeing a lot of standalone volume in the field. We're really able to process much more challenging samples and a lot of other tests out there.

And that peace of mind, that performance advantage is really sort of standing on its own two feet and allowing us to really take a lot of share in the market. Obviously small numbers still, but very exciting to see the progress this last quarter and for the remainder of the year.

Yeah, I can answer that. And really, when we're looking at sort of well, just the EBITDA and profitability, we almost talk about that in a similar breath to free cash flow burn. And we've been very sort of clear that getting to profitability, getting to cash flow break even, it's a key focus for the company.

We're well on track to get to cash flow break even by the end of 2021. And if you look at the business excluding screening, actually that business now is just a positive, it's generating positive cash flow. And so we've achieved that with the rest of the business. We continue to make heavy investments to build out the commercial infrastructure on screening. And that's going to continue throughout 27 as we continue to ramp up. We do expect at a point in 27 that we'll reach some sort of critical mass in our commercial spending. And we'll start to get a lot of leverage as the screening growth profit continues to increase. And this reduction in the shield cost per test is going to help us gather.

And we should start to see screening, start to ramp down in the burn sometime in 27. And that business itself getting to break even in 2028. So we're well on track with what our expectations were. We're very focused on getting to profitability and cash flow. What could bring that forward? I think in the previous answer, we talked about getting ADOT designation for Gardener 360 with an increase in the medical price and potentially increase in Gardener 360 ASP. If and when that happens, obviously that's going to again generate incremental bottom-like cash and profit for us. And so that could accelerate. That break even and could accelerate our profitability ramp following that. So again, I think we're tracking very nicely to our expectations.

I think right now, I think a lot of the growth is really sort of tissues tending on its own two feet. It's a product that can essentially utilize much smaller tissue samples and a lot of the tests that are out there that I think is a lot of the sort of initial traction that we see with that product. But it's also one that is really one of the most comprehensive products on the market in a very large genomic panel, genome-wide methylation. It's now a whole transcriptome as well.

And so it's really one of the most comprehensive offerings on the market. We also recently rolled out a lot of the apps that we had in our liquid side on the tissue side as well. And so it's really benefiting from Infiniti AI, the platform that we have in terms of developing a lot of these differentiating clinical applications. And so obviously this loads well for that franchise in the future as concurrent testing does become more and more prevalent and more and more the standard of care for many tumor types.

Yeah, in terms of reveal, I can say that I think we're making progress on the submissions and the packages we have there. I mean, certainly IO and breast are probably the closest to the finish line. I think we're hopeful that we can get at least one or both of them by end of this year. And, you know, obviously making some good progress as well. Obviously taking a little bit longer than we would have liked. But, you know, I think we're very confident that we can get these over the finish line. And we have a number of other submissions that sort of are under development and in preparation. As soon as the associated manuscripts get published, we'll be submitting those as well.

So we have a lot of sort of balls in the air in terms of reveal. And we know that it's going to be a very, very big sort of franchise for us going forward as soon as we get some of these reimbursement wins.

Regarding the SHIELD workflow improvement, yeah, actually we are refocused on emaculation-only, which the information is in the current version pipeline activities for us in terms of hopefully continuing to see improving the SHIELD performance.