Guardant Health, Inc. (GH) Q2 2026 Earnings Call Transcript

Hello, everyone. Thank you for joining us, and welcome to the Guardant Health Second Quarter 2026 Earnings Call. I will now hand the conference over to Zarak Khurshid, VP of Investor Relations. Zarak, please go ahead.

Thank you. Earlier today, Guardant Health released financial results for the quarter ended June 30, 2026. Joining me today from Guardant are Co-CEOs, Helmy Eltoukhy and AmirAli Talasaz; and Chief Financial Officer, 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-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 Guardant issued today as well as in our 10-Q and other filings with the SEC. Guardant 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 Helmy.

Thanks, Zarak. Good afternoon, and thank you for joining our second quarter 2026 earnings call. Starting on Slide 3. The platform we have built at Guardant 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 the compounding technology, data and clinical insights it generates across the disease continuum. Q2 was a landmark quarter in advancing that vision. During the quarter, we received FDA approval for Guardant360 Liquid CDx as well as approval for a higher-throughput, lower-COGS Shield workflow. In addition, we achieved two significant Shield milestones, inclusion in the American Cancer Society's colorectal cancer screening guidelines and, just this month, a major coverage decision from UnitedHealth Group. Together with continued broad-based 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 faced a familiar but frustrating question: what next? Her disease had become harder to control. Tissue was limited from prior biopsies and may not be representative of her current disease and another invasive procedure would have delayed treatment decisions. Her oncologist ordered a Guardant360 Liquid test to provide a comprehensive real-time view of her cancer through a blood draw. The result changed the conversation. Guardant360 Liquid identified homologous recombination deficiency, or HRD, which occurs when cells lose their ability to accurately 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 oncologists shifted her treatment plan to a biomarker-informed approach that included platinum-based therapy, to which she responded well, with manageable side effects. Turning to our revenue performance on Slide 4. We delivered $335 million of revenue in the second quarter, representing 44% year-over-year growth. The growth was strong and broad-based across our Oncology, Biopharma & Data and Screening business lines. Taking a closer look at our Oncology business on Slide 5. Oncology revenue grew 38% year-over-year, driving Q2 revenue of $219 million. Oncology test volumes rose 63% to approximately 104,000 tests, up from 64,000 in the prior year period with strength across all products. Turning to Slide 6. The tremendous 63% growth in Oncology volume represented another quarter of acceleration, reflecting the increasing strength of our portfolio across both therapy selection and MRD. Guardant360 Liquid year-over-year volume growth accelerated from the first quarter, delivering greater than 30% growth, benefiting from continued Smart Platform adoption. Guardant360 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% year-over-year, reflecting continued strength in MRD and growing adoption of the therapy monitoring use case. Moving to Slide 7. I want to spend a moment on what we believe is one of our most underappreciated assets, our data. Every patient we test deepens 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 100 tumor types. This is the raw fuel that powers InfinityAI, enabling the discovery of novel biological signatures, the development of new clinically actionable Smart apps and the acceleration of drug discovery for our biopharma partners. At ASCO in June, we showcased several innovative new tools built on our InfinityAI platform, and we are seeing a very strong positive response. Turning to Slide 8. In May, we received FDA approval for Guardant360 Liquid CDx, the most advanced FDA-approved liquid biopsy panel with 100x more content versus our legacy FDA-approved CDx product. Guardant360 Liquid CDx is significant for several reasons. Most notably, it reinforces Guardant's leadership in the field of liquid comprehensive genomic profiling testing, with Guardant360 Liquid CDx representing the only FDA-approved liquid biopsy test integrating both genomic and epigenomic content. Over time, Guardant360 Liquid CDx will help to simplify our therapy selection portfolio by consolidating multiple offerings into a single product. We're also excited by the potential for Guardant360 Liquid CDx to complement Guardant360 Tissue to drive greater adoption. We remain on track to obtain ADLT designation for Guardant360 Liquid CDx in the first half of 2027. In June, we began a phased rollout of Guardant360 Liquid CDx to our U.S. customers, and we plan to offer widespread availability of the test following ADLT 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 9. 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 experienced 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 in late-stage cancer, helping predict therapy response months before imaging, and with seamless connectivity to Guardant360 Liquid, it can help physicians to act sooner and with more precision. Late-stage cancer therapy monitoring alone is a multimillion-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 MolDX for coverage for breast cancer surveillance, immuno-oncology monitoring and chemotherapy monitoring, and those initiatives continue to progress. Shifting to our Biopharma & Data business on Slide 11. Revenue grew 9% year-over-year to $61 million, which marks a 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 of our Smart Platform to leading biopharma companies. During the quarter, we received FDA approval for Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS, the first targeted therapy approved for adults with HER2 or ERBB2 mutant advanced non-small cell lung cancer as an initial treatment option. We also received FDA approval for Guardant360 CDx as a companion diagnostic for Arvinas and Pfizer's VEPPANU for ER-positive HER2-negative ESR1-mutated advanced breast cancer. We also announced a collaboration with Nuvalent to develop companion diagnostics with an initial focus on Guardant360 Tissue. With that, I'll now turn the call over to AmirAli for an update on Screening.

Thank you, Helmy. 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 ten 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 colorectal cancer screening, they can opt in to receive multi-cancer detection results covering nine additional cancer types beyond colorectal cancer. The release of this report is contingent on patients authorizing the release of their medical records to Guardant as part of our data collection initiative. We are 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 multi-cancer detection reports. With colorectal cancer screening still representing such a significant unmet need, colorectal cancer remains our primary commercial focus. Now moving on to Slide 13 for an update on the Screening business. Q2 was another fantastic quarter for Shield. We delivered $53 million of Shield testing revenue, driven by approximately 66,000 tests compared to $15 million of revenue and approximately 16,000 tests in Q2 of 2025. Turning to Slide 14, which shows 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, direct-to-consumer 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 test included in both ACS and NCCN guidelines. And UnitedHealth 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-COGS Shield workflow. Let's focus on the latest scaled Shield commercial engine on Slide 16. Shield's commercial reach continues to expand rapidly on personal promotion, campaigns, 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 co-promotional 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 NCCN guidelines in June 2025 and to the American Cancer Society guidelines in May 2026. ACS guideline inclusion is particularly important because it triggers state-level coverage mandates in roughly a dozen states for commercial payers. An exciting result of these guideline wins has been positive momentum in our payer discussions and the sooner-than-expected UnitedHealth coverage policy update that I mentioned earlier. This coverage will be effective starting on August 1, which includes Shield as a covered primary colorectal cancer screening option for average risk adults aged 45 and older. UnitedHealth is the largest commercial insurer in the U.S. 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 the U.S. eligible for colorectal cancer screening, representing a $50 billion U.S. addressable screening market. As a result of ACS guideline inclusion and the UnitedHealth 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 FDA approval for a higher-throughput, lower-COGS 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 UnitedHealth 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 fronts at Guardant Health. On behalf of Helmy and myself, I want to express our deepest gratitude to our leaders and the whole Guardant team. Watching this team's focus, integrity and dedication to our mission continues to inspire us both every single day. With that, I'll now turn the call over to Mike for more detail on our financials.

Thanks, AmirAli. Turning to Slide 20. I'll walk through our second quarter results; unless otherwise noted, growth rates are year-over-year. Second quarter revenue reached $335 million, up 44%. Growth was broad-based with strong contributions from Oncology, Biopharma & Data and Screening. Oncology revenue was $219 million, an increase of 38%. Oncology test volume grew 63% to approximately 104,000 tests, reflecting strength across the portfolio. Within the portfolio, Guardant360 Liquid volume increased more than 30%, driven by continued adoption of our Smart apps. Guardant360 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 our submissions to MolDX for Medicare reimbursement covering breast MRD and immunotherapy and chemotherapy response monitoring continue to progress. Our Biopharma & Data business delivered record quarterly revenue of $61 million, up 9%, reflecting the increasing strategic value of our Smart Platform and InfinityAI offerings to biopharma 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 quarter ahead of broader reimbursement coverage. With Shield now included in ACS guidelines and UnitedHealthcare coverage beginning in August, we expect the commercial mix to continue to increase in the second half of the year. Turning to Slide 21. As AmirAli noted, the FDA recently approved a higher-throughput, lower-COGS 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 non-GAAP gross margin was 67% compared with 66% a year ago. The improvement reflects lab efficiency, disciplined execution and tight cost control. As planned, we completed the Guardant360 Liquid transition to NovaSeq 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-GAAP operating expenses were $288 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, advance Shield HCP and DTC programs and support Oncology growth. Adjusted EBITDA loss was $56 million compared with a loss of $52 million in the second quarter of 2025. Quarter end cash and investments were approximately $1.2 billion, and free cash flow burn in Q2 was $70 million compared with $66 million a year ago. The year-over-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 balance 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 Guardant360 Liquid, strong commercial execution and the impact of recent product upgrades in Guardant360 Tissue, as well as continued growth in Reveal across MRD and therapy monitoring. Our Biopharma & Data outlook is unchanged 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 UnitedHealthcare coverage, which becomes effective in August. Our full year non-GAAP gross margin outlook remains 64% to 65%. The range incorporates lower testing costs for Guardant360 Liquid and Shield in the second half, partially offset by product mix, as Shield and Reveal volumes scale. We intend to continue to reinvest incremental Screening gross profit to support commercial expansion. As a result, we now expect 2026 non-GAAP 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 million 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 Shield's 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-over-year improvements in cash generation, and we remain committed to achieving company-wide cash flow breakeven by the end of 2027. Turning to Slide 24. Several catalysts we discussed last quarter are now in hand. In Oncology, the NovaSeq X transition is complete and Guardant360 Liquid CDx is FDA approved. Our priorities are continued expansion of Smart Platform apps, the launch of Reveal Ultra and broader Reveal reimbursement. The ESR1 monitoring launch remains contingent on FDA approval of camizestrant. In Biopharma & Data, our priorities are to continue to advance CDx programs, broaden strategic partnerships and scale InfinityAI. In Screening, we obtained ACS guideline inclusion and are excited about the UnitedHealthcare coverage, both of which will help broaden access and adoption of Shield. We're also expanding Shield internationally through our self-pay channel. To close, Q2 demonstrates the breadth of our growth and the progress we are making in driving efficiencies across our operations. We are investing in the areas with the greatest long-term potential while maintaining our commitment to cash flow breakeven. With that, we'll open the call for questions.

Your first question comes from the line of Kyle Mikson with Canaccord.

Congrats on a great broad-based performance in the quarter. On Screening, first, UnitedHealth and ACS obviously open the market up to those under 65-year-olds. Could you elaborate on the near- and long-term ASP and the volume impact? After August, the volume tailwind could be material, but pricing hasn't been finalized for these commercial plans. Secondly, on USPSTF: with all this happening, what's your view on the late August meeting? Do you still expect a late '27 or early '28 time frame for inclusion?

Thank you, Kyle. We are very excited about the recent developments with ACS and UnitedHealth coverage. As I mentioned in the prepared remarks, roughly 70 million lives are covered for Shield, about 60% of the whole market. This UnitedHealth win could give us interesting benefits; we are excited to see how the rest of the year will play out. It should be a tailwind for volume and will help us strategically build our commercial side of the volume, including younger patients, to make sure they get access to this breakthrough technology. ASP will take some time. For ASP impact, we need to go through conversations with payers and show a history of collections in order to realize upside. So on ASP, we need to be patient. For USPSTF, our expectation is unchanged: it looks like new members will be in place and the August meeting is going to happen. We are monitoring developments. It is interesting that some payers are engaging with us even before USPSTF, and we'll see what happens.

Your next question comes from the line of Subbu Nambi with Guggenheim.

Congratulations on another record Oncology volume and Shield quarter. Regarding the Oncology volume guide, could you give us the puts and takes on the 50% guide raise? Is this largely from Reveal in metastatic stage? How is per-patient testing cadence looking today? For Q3, given the tough comp in Guardant360, how should we think about Guardant360 volume growth?

Great. Thanks, Subbu, for the question. We're really excited about the quarter's Oncology volumes. We had a tremendous volume ramp that was broad-based across the portfolio. Guardant360 Liquid grew over 30% year-over-year. Tissue continued to accelerate and was higher than Guardant360 Liquid. Reveal was also over 100% growth. All of them are contributing to continued strong volume for the second half of the year. We have strong comps for Q3 and Q4 for Guardant360, but we are confident we can continue the momentum from the first half on all products and hit the 50% full-year Oncology volume growth guide. Mike may want to add.

To reiterate, our guide of 50% full-year Oncology volume growth is very strong. We have tough comps each quarter, and we'll continue to manage that, but our guide for Q3 and Q4 still implies very strong Oncology volume growth.

Regarding UnitedHealth, it was unexpected for us as well and much sooner than we anticipated. We have a multiyear relationship with United because of our Oncology products and coverages and have had multiyear conversations about the value of Shield. In the payer landscape, nobody wants to be first or last, so while we don't expect major wins in the short term from other major payers, UnitedHealth's action has gotten attention. We are engaged in conversations with other plans, and we will see what develops.

Your next question comes from the line of Puneet Souda with Leerink.

Again, congratulations on the impressive growth in the core business and Shield. Guardant360 has been on the market for years and is revamping and now growing faster. Where are we in the S-curve of growth? On Shield, what are the drivers for upside — sales reps, DTC ads? How should we think about sequential ramp for Shield in Q3 and Q4?

Thanks, Puneet. We're very excited about what we're seeing. Guardant360 is one of the most comprehensive tests available. It covers broadly all relevant genomic markers and is the only test integrating genome-wide methylation coverage, enabling many next-generation applications of liquid biopsy. Many physicians are just starting to get experience using it with patients, and when they find actionable results they couldn't find before, it builds confidence and usage over time. We're just scratching the surface of what the platform can do. We think we can continue to drive growth not only in the current one-test-per-patient era but by supporting repeat testing at progression, which is a big market multiplier and supports continued Guardant360 growth over years.

On Shield, the sequential growth from Q1 to Q2 was very strong — a 22,000 test step-up. Multiple factors compounded: the Quest co-promotion launched, direct-to-consumer campaigns started, and we added to our field force. There are nonlinear effects where rep productivity increased meaningfully when combined with Quest co-promotion and DTC. We do not expect multiple new things all hitting at once in Q3. We increased our guide by 40,000 samples for the year, which translates at the midpoint to a sequential growth of about 12,000 tests quarter-over-quarter in the second half. We're being thoughtful and believe this is a reasonable guide for the rest of the year.

Your next question comes from the line of Mark Massaro with BTIG.

Congratulations on another great quarter. Helmy, you've talked about reframing the value of diagnostic tests. As we think about ADLT rate of $8,455, how are you thinking about negotiating with United? What is your appetite for a discount? How important are ACS and NCCN endorsements, and to what extent might they derisk USPSTF?

I'll let AmirAli answer that.

We just received coverage, so we need to go through the process with UnitedHealth to see the final details, including patient responsibility and any possible cost-sharing. Medicare pricing is typically central to these conversations and our pricing is transparent. We'll see how it evolves. UnitedHealth decided to act before USPSTF, and that has attracted attention. Our progress in the field and the impact we're showing are generating additional conversations with other payers. We do not expect major additional wins for the rest of the year, and we have not included anything in our guide for additional wins.

Your next question comes from the line of Dan Brennan with TD Cowen.

On ADLT: when you expect the price to be finalized, is $8,455 the right number to use? We modeled a revenue uplift in '27 and '28 based on realized price capture. Can you share how much MA and commercial realized price increases are reasonable to assume, and what drop-through rate to pretax would be — how much would you reinvest vs. how much accrues to the bottom line?

We're going through the ADLT process now and are expecting a price of $8,455, which would be an uplift from our current Medicare price of $5,000. It will take time for Medicare Advantage and commercial payers to align pricing with the Medicare rate; historically this can take 12 to 24 months to flow through. Once we get ADLT, we expect a nice uptick in Guardant360 ASP, which should continue to improve over the next 12 to 18 months. Regarding reinvestment, we have been reinvesting incremental gross profit, particularly on Screening, to support commercial expansion. With Oncology, some incremental gross profit would be allowed to drop to the bottom line to accelerate our timeline to cash flow breakeven, but we would also reinvest in innovation and expand commercial operations. We aim to get to cash flow breakeven as quickly as possible, and increased gross profit could allow us to accelerate that timeline currently targeted for the end of 2027.

Your next question comes from the line of Daniel Markowitz with Evercore.

Congratulations on the quarter. At Investor Day last year you gave targets for 2028. Given recent developments, how have trends changed relative to those targets? For Guardant360, should we think about ASP uplift moving you closer to $5,000 from prior targets? And how should we think about reinvesting versus drop-through to margins?

Mike will take that.

At our Investor Day last year, we increased our 2028 revenue target to $2.2 billion, implying a growth rate over three years of just over 30%. So far, we are doing very well against that target. Our current guidance for full year 2026 is 36% to 38% growth, which gives us confidence in achieving the $2.2 billion. Regarding the ADLT rate of $8,455 and long-term Guardant360 ASP near $5,000, that is probably in the ballpark. It may take 12 to 24 months to reach that level as payers update pricing. Realizing overall approximately 60% of the Medicare rate is currently where we are with Guardant360. On profitability, incremental gross profit would be a mix: some would drop to the bottom line to accelerate breakeven, and some would be reinvested in the business, including innovation and commercial expansion.

Your next question comes from the line of Casey Woodring with JPMorgan.

Congrats on the print. Helmy, can you give a sense of how therapy monitoring volumes are tracking and how they contribute to Reveal's greater-than-100% volume growth? Can you quantify the revenue opportunity once reimbursement for immuno-oncology and chemotherapy monitoring is in place? Also, any material uplift in volumes driven by the FDA approval for Guardant360 Liquid — has that moved doctors who were on the sidelines?

Great questions. Therapy monitoring is gaining real traction and is a significant opportunity. Therapy monitoring fits hand in glove with our portfolio: you test patients for therapy selection and then use blood-based monitoring to see response. Therapy monitoring is the future of oncology for moving from biopsies and scans to quantitative blood-based management. We are seeing very good uptake from Guardant360 orders moving into therapy monitoring. This is a strong leading indicator for reimbursement success. There are about one million late-stage patients, and therapy monitoring could be a multimillion-test annual opportunity if patients are monitored multiple times per line of therapy. Regarding the FDA approval, it was late in the quarter and we began a phased launch, so it's early to quantify the impact. Feedback has been positive, and we will lean into this in upcoming quarters.

Your next question comes from the line of Kallum Titchmarsh with Morgan Stanley.

One for Helmy: can you provide more color on Reveal Ultra, including indication roadmap and commercial strategy for capturing share? And for AmirAli, on multi-cancer detection, what opt-in rates have you been seeing for the multi-cancer detection reports, and how are you using the data you are generating?

On Reveal Ultra, we are being thoughtful about the launch and which indications we prioritize. Development has gone very well and the performance is strong, routinely hitting limits of detection well below one part per million. In real samples, the sensitivity is promising. We are focused on making Reveal Ultra seamless with Reveal, Guardant360 and our Tissue products to maximize physician adoption. We are also considering reimbursement timelines and clinical validation. We will prioritize indications where we can gain traction early. Further details will be provided as we get closer to launch.

On Shield multi-cancer detection, data collection is going very well, driven by strong attachment rates. A majority of physicians ordering Shield are opting in to receive the multi-cancer detection results report, which supports our data initiatives and continued development.

Your next question comes from the line of Dan Leonard with RBC Capital Markets.

On the UnitedHealthcare decision: to the degree price sensitivity becomes a topic in that customer base, is there anything you could do to address it, such as co-pays or other mechanisms? Or is USPSTF really the solution to that? How are you thinking about this?

We will see UnitedHealth's details regarding co-pay and patient responsibility. Post-USPSTF, any co-pay would go away. Regarding rebates, I have no comments to share at this time.

Your next question comes from the line of Mason Carrico with Stephens. Your next question comes from the line of Evie Koslosky with Goldman Sachs.

Given the acceleration in therapy monitoring for Reveal, can you walk through cross-selling benefits between therapy monitoring and therapy selection? Any color on sales force productivity related to this?

These are typically the same oncologists ordering both tests. The two products work together: you test patients to determine therapy and then monitor therapy response. It's a one-two punch that creates a longitudinal view for each patient through every line of treatment and progression. This is realizing our platformization vision and is helping drive adoption and sales force productivity.

Your next question comes from the line of Paige Chamberlain with Wolfe Research.

What is the potential impact to volumes for the Guardant360 Tissue test after the FDA approval of the liquid test? Could reimbursement of the liquid test under the NCD lead to volume acceleration for Tissue? Also, given the phased rollout of the FDA-approved liquid test, can we expect any volume acceleration ahead of ADLT pricing?

We have not baked much into guidance given the phased rollout, but we are excited about the potential once we get ADLT designation and a more complete CDx rollout. Guardant360 Tissue is our second fastest-growing Oncology product and accelerated this past quarter. Tissue is gaining traction because it can handle more challenging samples and is one of the most comprehensive offerings on the market. It's benefiting from InfinityAI and the apps we developed on the Liquid side. Concurrent testing becoming more prevalent bodes well for Tissue long-term as well.

Your next question comes from the line of Brad Bowers with Mizuho.

I wanted to address profitability. With the Shield COGS reduction and other levers, how are you thinking about profit and potential EBITDA inflection over the next 12 months? Does ADLT pricing factor into accelerating that inflection?

We discuss adjusted EBITDA and free cash flow burn together. Achieving cash flow breakeven is a key focus. Excluding Screening, the rest of the business is adjusted EBITDA positive and generating cash. We continue to invest in Screening commercial infrastructure, which will continue through 2027 as we ramp. We expect to reach a critical mass in commercial spending in 2027 and start to get leverage as Screening gross profit increases. The Shield cost per test reduction will help us get there. We expect Screening to ramp down in burn sometime in 2027 and be breakeven in 2028. If we receive ADLT designation for Guardant360 and realize increased Medicare and commercial ASPs, that would generate incremental bottom-line cash and could accelerate our path to breakeven. We are tracking well to expectations.

Your next question comes from the line of Tycho Peterson with Jefferies. No response; the next speaker is Noah on behalf of Tycho.

Congrats on the quarter. Regarding Guardant360 Tissue, you're outgrowing the broader market in this application. Are the share gains tied to concurrent testing trends or an actual shift in provider preference? What does the underlying assumption look like for growth in this market going forward?

A lot of the growth for Tissue is it standing on its own merits. It can utilize smaller tissue samples and has one of the most comprehensive panels including genome-wide methylation and whole transcriptome. We recently rolled out many of the apps from Liquid onto Tissue, and it's benefiting from InfinityAI. This positions Tissue well as concurrent testing becomes more prevalent and more standard of care across tumor types.

One more question, please, Ellen.

Certainly. Our final question comes from Catherine Schulte with Baird.

On Reveal, can you talk through expectations on when you might hear back from MolDX on some indications? Some submissions are approaching the year mark. Also, regarding the lower-COGS version of Shield, the PMA supplement looks like it streamlines to a methylation-only workflow, removing fragmentomics and the somatic component. Can you discuss the development work that went into that and how that might inform future iterations of the test?

On Reveal, we're making progress on submissions and packages. IO and breast are probably the closest to the finish line and we are hopeful to get at least one or both by the end of this year. We're also making good progress on chemotherapy monitoring. It's taking a little longer than we'd like, but we're confident we can get these over the finish line. Additional submissions are under development and will be submitted as associated manuscripts are published. We have many initiatives underway for Reveal, and we know it will be a very large franchise once we secure reimbursement wins.

Regarding the Shield workflow improvement, we focused it on methylation-only, which is already part of the current Shield V1 data. The algorithm updates and multimodal Shield pipeline activities are generating exciting opportunities for continued performance improvement.

This concludes today's call. Thank you for attending. You may now disconnect.