Guardant Health, Inc. Q1 FY2026 Earnings Call

Good afternoon. Thank you for attending the Guardant Health Q1 2026 Earnings Call. My name is Matt, and I'll be the moderator for today's call. The operator provided instructions regarding the conference. I'd now like to pass the conference over to our host, Zarak Khurshid, VP of Investor Relations. Zarak, please go ahead.

Thank you. Earlier today, Guardant Health released financial results for the quarter ended March 31, 2026. Joining me today from Guardant are Helmy Eltoukhy, Co-CEO; AmirAli Talasaz, Co-CEO; and Mike Bell, Chief Financial Officer. Before we begin, I'd like to remind you that during this call we 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 the 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 First Quarter 2026 Earnings Call. Starting on Slide 3, we entered 2026 with significant momentum that accelerated through Q1, driving a remarkable quarter for Guardant Health. These results validate our strategic vision of delivering increasingly more actionable insights to physicians and patients across the care continuum. Notably, our commercial flywheel has achieved a new level of velocity, delivering our fastest year-over-year percentage revenue growth in the last 5 years and surpassing the $1 billion trailing 12-month revenue milestone. This is a testament to the burgeoning scale and long-term durability of our business. Before I share our results in more detail, I'd like to share a story that illustrates the real-world impact of our tests. A 77-year-old Atlanta resident recently completed a Shield CRC test. The results came back positive and the patient underwent a diagnostic colonoscopy during which a lesion was discovered and biopsied. The lesion was subsequently confirmed to be malignant by pathology. The patient then underwent surgical resection of the malignant lesion, which was confirmed to be highly localized. The patient welcomed this news from her oncologist and was further relieved that no additional treatment was necessary. Patient outcomes like this are one of the many reasons we have benefited from accelerating adoption and growth. Turning to our revenue performance on Slide 4. We had a phenomenal start to 2026, delivering $302 million of revenue in Q1, representing 48% 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 growth accelerated to 36% year-over-year, driving Q1 revenue of $205 million. Oncology test volumes rose 47% to approximately 86,000 tests, up from 59,000 in the prior year period. This was the highest year-over-year percentage growth on oncology volume we've seen in nearly 3 years with strength across all products. We're excited to see the expanding role of our portfolio across the cancer care continuum. Turning to Slide 6. Our 47% year-over-year volume growth reflects the increasing breadth of our portfolio across both therapy selection and MRD. Guardant360 Liquid delivered 30% volume growth year-over-year, while Guardant360 Tissue was our second fastest-growing product. Smart platform innovation continues to translate directly into volume growth for both products with InfinityAI powering a steady cadence of new clinical applications that are driving deeper adoption among oncologists. We have a strong pipeline of additional smart apps in development, and we look forward to continuing that cadence. Reveal remained our fastest-growing product with volumes up over 100% year-over-year, reflecting strong adoption of Reveal in MRD across indications and enthusiasm for our new therapy response monitoring use case among our customers in its first full quarter post launch. Moving on to Slide 7. With each patient tested, our data treasury continues to deepen and diversify. Our data repository harnesses insights from over 1 million patient samples, 500,000 epigenetic profiles across more than 100 tumor types, and each new sample helps compound the breadth and uniqueness of what we can deliver over time. By applying our InfinityAI learning engine to this expanding data moat, we uncover novel biological signatures, power new smart app development and accelerate therapeutic discovery for our biopharma partners. The result is a compounding flywheel wherein data drives better insights, which, in turn, fuels volume growth and strengthens our data advantage. Turning to Slide 8 to take a closer look at our Reveal data pipeline. We continue to make strong progress in generating and publishing compelling data across multiple cancer types and indications. We have submitted data packages to MolDx to support coverage in breast cancer surveillance, immuno-oncology monitoring and chemotherapy monitoring, and we are engaging constructively with MolDx through the Reveal process. Each submission represents a potentially meaningful reimbursement catalyst, and we are excited about the ASP upside that favorable outcomes would unlock. We are also advancing our work towards the MolDx submission for CDK4/6 inhibitor monitoring. Looking further ahead, we have ongoing studies across more than 5 additional tumor types in both the adjuvant and surveillance settings. The breadth of this pipeline gives us real confidence in Reveal's trajectory and its expanding role across the cancer care continuum. Turning to Slide 9, we continue to make strong progress across the Guardant360 portfolio on multiple fronts. For Guardant360 Liquid, our FDA review remains on track. When approved, Guardant360 Liquid will become the most comprehensive FDA-approved liquid biopsy for therapy selection on the market. Moreover, this development will help simplify ordering across our therapy selection portfolio and create better connectivity across our larger testing ecosystem. On the Tissue side, we are excited to announce our second major platform upgrade in less than a year, expanding RNA testing to whole transcriptome. This further builds on the genomic and epigenomic foundation of our Smart platform, and we believe reinforces Guardant360 Tissue's position as best-in-class in the tissue CGP market. We expect these upgrades to be a meaningful volume catalyst for both Liquid and Tissue, particularly as it opens the door to converting current nonusers. Turning to Slide 10. Guardant had another strong showing at AACR this year. Together with our independent collaborators, 38 abstracts were presented spanning our entire oncology portfolio. The depth of the Smart App data was remarkable. 25 of the abstracts featured InfinityAI generated findings, which speaks to how rapidly this platform is maturing. We were particularly encouraged to see concrete evidence of InfinityAI enabling therapeutic response prediction and improving detection of clinically challenging alterations like ALK-fusions and MTAP deletions. These are exactly the kind of insights unlocked by our data treasury and epigenomic capabilities that truly differentiate our platform. Shifting gears to our Biopharma & Data business on Slide 11. We delivered another strong quarter with revenue growing 17% year-over-year to $53 million. The last few months have been highly productive with respect to our CDx strategy, which included Guardant360 CDx FDA approval for Pfizer's Braftovi in BRAF V600E-mutant metastatic colorectal cancer and this week's CDx FDA approval with Arvinas and Pfizer's VEPPANU for ER-positive, HER2-negative, ESR1-mutated advanced breast cancer. Our CDx franchise now spans 26 approvals across the U.S., Japan and Europe, backed by a robust pipeline across multiple partnerships with leading biopharma companies. In the quarter, real-world evidence generated from InfinityAI as supplemental data alongside clinical findings contributed to the first tumor-agnostic approval of Daiichi Sankyo's ENHERTU in Japan. We also saw further strengthening of our relationships with leading biopharma companies, including a multiyear agreement with Merck to develop companion diagnostics and commercialize novel therapies as well as last week's announced collaboration with Nuvalent to develop companion diagnostics with an initial focus on Guardant360 Tissue. Together, these developments reflect the growing strategic value of our smart platform and InfinityAI to leading biopharma companies and reinforce our confidence in sustained growth in this business. With that, I'll now turn the call over to AmirAli for an update on screening.

Thanks, Helmy. Moving on to Slide 12. Q1 was another strong quarter for Shield. We delivered $42 million of Shield testing revenue driven by approximately 44,000 tests compared to $6 million revenue and approximately 9,000 tests in Q1 of 2025. Revenue growth has closely tracked volume growth, reflecting favorable collections and a disciplined focus on reimbursable lives. Now roughly 18 months into the commercial launch, we continue to break records and look forward to sustained strong growth throughout the remainder of 2026. Moving to Slide 13 for a closer look at Q1 screening highlights. We saw strong volume throughout the quarter and exited the quarter with accelerated momentum in March, which gives us real confidence in our trajectory for the remainder of the year. Our growth was fueled by continued improvement in sales rep productivity and amplified by a series of marketing initiatives that came together in the quarter. We launched our DTC and influencer campaigns in conjunction with colorectal cancer awareness month, including our national campaign with Patrick Dempsey, which I will cover on the next slide. Our Quest collaboration launched nationwide in late Q1, and we are pleased with the early signals. Quest is already opening doors for us in health systems and physician practices where we did not previously have a strong direct presence. Shield continues to demonstrate a high adherence rate of over 90%, which is one of the key differentiators of Shield versus other noninvasive modalities. Finally, we launched Shield Multi-Cancer Detection in Asia through our partnership with Manulife, extending our reach into an important new market segment. Taking a closer look at our direct-to-consumer programs on Slide 14. Q1 marked our first comprehensive DTC campaign spanning TV, digital and influencer channels and the results exceeded our expectations. Together, these efforts generated over 1 billion impressions. The centerpiece was our partnership with Patrick Dempsey, actor and a cancer advocate, who shared his personal experience using Shield during colorectal cancer awareness month. We saw a meaningful step-up in consumer engagement, including website traffic and consumer-initiated provider engagements, which we expect to translate into greater adoption of Shield. Turning to Slide 15. Complementing our DTC program, we have expanded our healthcare provider marketing initiatives, which drove record HCP engagement in Q1. Our March campaign featured targeted messaging to about 200,000 HCPs emphasizing that many millions of Americans remain unscreened, and that Shield is the only FDA-approved blood test for CRC screening with Medicare coverage. Also, we continue to make great progress to enhance physician and patient experience. We are rapidly expanding the number of accounts with direct integration into their Epic, eClinicalWorks and Athenahealth EMR systems. Moreover, we officially launched our collaboration with Quest Diagnostics nationwide in late Q1, which has fast tracked our EMR connectivity to more than 650,000 HCPs. We expect this to meaningfully increase depth of ordering among connected physicians. Quest national sales team has now started actively promoting Shield. While still early days, we are pleased with positive contributions we are seeing. Finally, our patient navigation team is actively helping practices connect patients to convenient phlebotomy access, utilizing our nationwide network of 40,000 phlebotomists as well as Quest's 8,000 patient service centers. Turning to Slide 16. At Guardant Health, we are dedicated to continuous improvement of our products and patient experience. We are excited to report that we recently received FDA approval to reduce the amount of blood collected from patients to process Shield test to 2 tubes from the original 4-tube kit. We applaud the FDA for their continuous collaboration and dedication to strong patient outcomes. Moving to Slide 17. 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. When a physician orders Shield for CRC screening, they can opt in to receive a multi-cancer detection results report. The Shield MCD report is available to Shield CRC patients who authorized the release of their medical records to Guardant. The launch of this initiative establishes a scalable platform for clinical data generation, enables assessment of the utilization of MCD results in patient care and provides a new avenue to expand patient access to Multi-Cancer Detection. The MCD report covers findings across nine additional cancer types behind CRC, including lung, breast, ovarian, pancreatic and others. We are encouraged by HCP and patient response to this data collection initiative and the strong opt-in that we are seeing. As a result, we believe we are building what will quickly become the largest clinical database of Multi-Cancer Detection outcomes from patients in the United States. Now on to Slide 18. During Q1, we announced the expansion of Shield multi-cancer detection in Asia through our partnership with Manulife. Manulife serves more than 13 million customers across Asia. We initially launched in three key markets: Hong Kong, the Philippines and Singapore. This is a differentiated go-to-market strategy, which leverages a direct channel to a large member base within those markets. With that, I will now turn the call over to Mike for more detail on our financials.

Thanks, AmirAli. Moving to Slide 19, I'll now review our first quarter 2026 financial results. Unless otherwise noted, all growth rates are year-over-year. Total revenue in Q1 increased 48% to $302 million, reflecting strong growth and continued momentum across Oncology, Biopharma & Data and Screening. Starting with Oncology. Revenue increased 36% to $205 million. We reported approximately 86,000 oncology tests in the quarter, representing 47% volume growth with broad-based strength across the portfolio. Guardant360 Liquid volumes grew 30%, supported by expanding clinical utility and continued traction of our Smart Apps. Guardant360 Tissue also continued to scale and remains our second fastest-growing oncology product. Reveal remains our fastest-growing oncology product with volume growth exceeding 100%, reflecting strong adoption in MRD and continued expansion in therapy response monitoring following its Q4 2025 launch. Average selling prices were stable sequentially with Guardant360 Liquid in the range of $3,000 to $3,100, Guardant360 Tissue above $2,000, and Reveal between $600 and $700. As a reminder, we've submitted data packages to MolDx for Medicare reimbursement covering breast MRD and both immunotherapy and chemotherapy response monitoring. Favorable outcomes from these submissions will provide upside to Reveal ASP. Biopharma & Data revenue was $53 million, up 17%, reflecting sustained demand and continued strength across sample testing, companion diagnostic projects and data products. In Screening, Q1 revenue was $42 million compared to $6 million in the prior year period. The increase was primarily driven by approximately 44,000 Shield tests in the quarter compared to approximately 9,000 in the prior year period. Volume tracked in line with expectations through January and February. And following the launch of our Quest partnership and successful HCP and DTC programs during colorectal cancer awareness month, we saw clear momentum build through March and exited the quarter strongly. Shield ASPs increased significantly year-over-year, reflecting the Medicare rate step-up from $920 to $1,495 that went into effect on April 1, 2025, following Shield's ADLT designation. As a reminder, after the initial 9-month period of list price-based reimbursement, Shield transitioned to market-based pricing at the start of 2026. Based on Commercial and Medicare Advantage payments received in 2025, the $1,495 Medicare fee-for-service rate is now established for 2026 and 2027. Out-of-period revenue in Q1 was broadly consistent with quarterly trends over the past year and totaled $22 million, which consisted of $18 million Oncology revenue and $4 million Screening revenue. Turning to Slide 20. Non-GAAP gross margin was 66% in Q1 2026, up from 65% in the prior year period. The improvement was primarily driven by lower Guardant360 Liquid cost per test reflecting the ongoing transition to NovaSeq X, which will be completed in May 2026. The transition reduced Guardant360 Liquid sequencing cost per test by nearly $200 versus Q1 2025. We also benefited from improved screening gross margins, which I'll discuss on the next slide. Non-GAAP operating expenses were $268 million, an increase of 34%, primarily driven by commercial investment. While R&D and G&A saw modest year-over-year increases, sales and marketing expense rose to $154 million in Q1 2026 compared to $94 million in the prior year period. This reflects continued investment in building out our screening sales infrastructure, advancing Shield HCP and DTC marketing programs and supporting ongoing oncology revenue growth. Adjusted EBITDA loss in Q1 was $59 million compared to a loss of $59 million in the first quarter of 2025. Free cash flow burn in Q1 2026 was $71 million compared to $67 million in the prior year period. The year-over-year change reflects an increase in the company-wide annual bonus payout in Q1 2026 compared to Q1 2025. Excluding this impact, free cash flow burn decreased by approximately $12 million year-over-year. We remain focused on disciplined cash management and are on track to decrease full year 2026 free cash flow burn compared to 2025. We ended the quarter with approximately $1.2 billion in cash and investments. Turning to Slide 21. Over the past year, Screening non-GAAP gross margin improved from 18% in Q1 2025 to 56% in Q1 2026. This improvement has been driven by an increase in Shield ASP, as I outlined earlier, and a decrease in Shield non-GAAP cost per test from $520 in Q1 2025 to $420 in Q1 2026, which is a result of higher volumes, disciplined cost management and efficient lab operations. As a reminder, we continue to expect Shield cost per test to decline to approximately $200 at scale, driven by further volume growth as well as workflow efficiencies and automation, which we expect to implement in 2027. Turning to Slide 22. Based on our strong first quarter performance and increased visibility, we are raising our full year 2026 revenue guidance to a range of $1.30 billion to $1.32 billion, representing growth of 32% to 34%. Oncology revenue is now expected to grow 28% to 29% with volume growth of greater than 35%. Demand fundamentals remain strong across the portfolio. Guardant360 Liquid should continue to benefit from Smart App adoption, while Guardant360 Tissue is building on recent upgrades and strong commercial execution. Reveal is expected to remain our fastest-growing oncology product, driven by MRD and therapy monitoring. Our oncology guidance does not include potential upside from FDA approval of Guardant360 Liquid or the launch of Reveal Ultra. We continue to expect Biopharma & Data to grow in the low double-digit range, supported by recent strategic partnerships, continued progress in our CDx pipeline and a combination of ongoing collaborations and new program starts. Given the momentum exiting Q1, the impact we're seeing from our DTC and HCP campaigns and the launch of our Quest collaboration, we now expect Screening revenue of $186 million to $198 million, driven by Shield volume of approximately 230,000 to 245,000 tests. Note that this improved outlook does not include upside from ACS guideline inclusion, which we continue to expect in the near term. We continue to expect full year non-GAAP gross margin in the range of 64% to 65%, which reflects ongoing improvements to Guardant360 Liquid and Shield cost per test, balanced with changes to product mix as Shield and Reveal test volumes scale rapidly. Given the strength and momentum we're seeing with Shield, we plan to continue reinvesting incremental screening gross profit to support commercial expansion during the year. Accordingly, we now expect 2026 non-GAAP operating expenses to be in the range of $1.05 billion to $1.07 billion, representing growth of 16% to 18% compared to 2025. We continue to expect full year free cash flow burn to be in the range of $185 million to $195 million, representing an improvement year-over-year. Excluding Screening, we expect the remainder of the business to be free cash flow positive for the full year 2026, and we remain committed to achieving company-wide cash flow breakeven by the end of 2027. Turning to Slide 23, we are executing well against our key 2026 priorities. In Oncology, we will complete the Guardant360 Liquid NovaSeq X transition this month and expect multiple product launches, including Reveal Ultra, FDA-approved Guardant360 Liquid and continued expansion of the Smart platform. Guardant360 Liquid ESR1 monitoring launch is dependent on FDA approval of camizestrant. Last week, the Oncologic Drugs Advisory Committee voted 6 to 3 against the claim that camizestrant demonstrated clinically meaningful benefit in HR-positive HER2-negative metastatic breast cancer. Ultimately, the FDA retains full discretion over its final decision, and we look forward to that outcome in the coming months. Importantly, the committee's discussion reinforced the broader consensus that ctDNA companion diagnostic therapy monitoring represents the future of precision oncology care. Furthermore, our revenue guidance does not reflect any impact from the potential approval of camizestrant. If it does receive FDA approval, this could represent a meaningful source of upside to Guardant360. In Biopharma & Data, we're advancing CDx programs and expanding strategic partnerships, including recent additions with leading biopharma companies and continue to scale our InfinityAI platform. In Screening, we've launched our Quest collaboration and expanded Shield into Multi-Cancer Detection markets in Asia through our partnership with Manulife. Overall, the business is delivering very strong growth, and we remain focused on disciplined execution as we scale. With that, we'll now open the call for questions.

The first question is from the line of Mark Massaro with BTIG.

Congrats on the strong beat and raise. I'll stick with the Shield question. So it's nice to see both volumes and revenue come in above my expectations. And you talked about volumes accelerated momentum in March. I was curious if you could just speak to your confidence around April. I would assume that that is tracking well since you raised the guide. And can you just give us a sense for why you raised the volume guide up for Shield? If I remember this correctly, I believe the prior outlook excluded benefit from Quest. So how much of this might be adding Quest into the calculus versus any other drivers that you're seeing?

Thank you, Mark. Yes, we are very proud of what we did in Q1 in terms of Shield volume. January and February went as we expected. But as we entered March, we saw momentum that was much better than what we expected. The root cause was multiple things working at the same time. We launched our DTC campaign, influencer campaigns, Quest went live at the same time, EMR connectivity helped in a very meaningful way, and we saw that continue. Based on the trends that we've seen in March, and while we don't want to get into detailed Q2 commentary, based on everything that we've seen, we have a lot of confidence in what we can deliver this year. We don't want to get ahead of ourselves, but we are very confident in the new guide. In terms of Quest contribution, we need to capture more data on how much Quest is helping us incrementally. Early indications are positive, and we are counting on some of that in our new guide, but in a thoughtful way. We will monitor how it goes in the months to come and have set the expectation accordingly.

Next question is from the line of Subbu Nambi with Guggenheim.

Congratulations on the print. Helmy, Guardant360, despite being on the market for over a decade, is growing 30% year-over-year. While you have previously said there is no one reason for this outsized growth, could you give us additional color on what is driving this? Is it CRC now starting to adopt Liquid? Is it Guardant360 testing or something else? And then as we look to full year guidance, how much of the guide raise is attributed to Guardant360 outlook?

Sure. Thanks for the question. Yes, we're very pleased with how, in its tenth year, Guardant360 continues to grow nicely. When we launched the smart liquid biopsy platform a few years ago, some saw it as a marginal addition to the liquid biopsy space. But this is a fundamental step change in terms of the power of liquid biopsy and its capabilities, allowing us to see phenotype and enabling capabilities that were not possible before. We're leaning into that, and adoption is growing. When we dig deeper, there's a lot of share gains happening and greater depth and breadth in terms of physicians that haven't traditionally used liquid biopsy for certain tumor types. Overall, the growth is very broad-based. What's even more exciting is that we're still in the early innings of the platform's capabilities on the Smart App side as well as longitudinal testing. We're still not testing at every progression and remain underpenetrated. We're confident the growth will continue in the short, medium and long term.

The next question is from the line of Patrick Donnelly with Citi.

Helmy, maybe one for you on the Reveal side. I think you talked about over 100% growth there. Can you just talk about what you're seeing in the market, the key drivers there? And then I know you mentioned you submitted a few data packages to MolDx on breast cancer surveillance and some of the monitoring pieces. Maybe just talk about the catalyst set on that front on the reimbursement side, what we should be looking for on the Reveal front?

Yes. We're very excited with how fast Reveal is growing and the depth we're seeing. We're continuing to see good growth in CRC, breast and lung cancers in the surveillance setting. Therapy monitoring has been a great addition and we're seeing strong traction there. This reflects the brand we've built over the last 12 years in oncology; when we launch something new, we tend to see outsized traction compared to newer competitors. We're making progress with our MolDx submissions. Volume is a leading indicator; you can't generate revenue without volume. When we get over the finish line with some of the submissions, they should position us well on revenue and ASP for the MRD business.

Next question is from the line of Doug Schenkel with Wolfe Research.

This is Colleen on for Doug. We've got a question on Shield ASP expectations. It looks like ASP is holding up a little better than we had expected. If we're doing the math right, it looks like you're expecting full year 2026 Shield ASPs a bit north of $800 per test. If possible, could you share what percentage of Shield volume came from CMS in the quarter and how you expect that to evolve over the year?

Yes, I can take that. Q1 was consistent with what we saw towards the back end of last year with a high proportion of Shield tests being either Medicare fee-for-service or Medicare Advantage. That's what's been driving the strong ASP over the last few quarters. As we look out for the remainder of the year, we're expecting to broaden the reach to patients under 65. We're not covered yet on the commercial side, so our expectation and our guide imply a tick down in the ASP for the remainder of the year as we build out commercial patient volume and ahead of commercial reimbursement. Today, it's predominantly Medicare and Medicare Advantage, but that mix will skew more toward under-65 patients throughout the year.

Next question is from the line of Casey Woodring with JPMorgan.

This is Sebastian on for Casey. Can you dig a little more into the Guardant360 Tissue growth you're seeing? You're growing well above the market. It seems like you're taking some share there. How sustainable are these share gains? And can you talk about the pathway to ASP upside from this whole transcriptome addition? I would expect that would be more than the $300 benefit you saw from the initial RNA element.

Yes. We're pleased with the growth in Tissue. One of the things that will further accelerate growth is if we get FDA approval for our Guardant360 Liquid test. That should streamline the portfolio, allow simplified ordering between the two products and help move everything onto the Smart platform. We believe this growth is sustainable. The trajectory is being led by Guardant360 Liquid and its advanced capabilities, and Tissue will have many of the same Smart Apps over time, so Tissue can benefit from Liquid's growth. Regarding whole transcriptome, we'll pursue the regulatory pathway and expect to submit to the FDA at some point. We believe we can qualify for ADLT status there as well, which should improve ASP substantially.

The next question is from the line of Puneet Souda with Leerink Partners.

First one on Shield: 90% adherence rate is impressive. AmirAli, could you talk about the Shield volume cadence through the year? How should we think about the next three quarters given the momentum you're seeing and the marketing and DTC efforts? And on the oncology side, Helmy, Guardant360 repeat use is an important driver. The camizestrant AdCom was resoundingly positive for ctDNA use but the trial design was the issue. Going forward, how should we think about repeat use from 1.3 average? How does that go higher in the future?

Thank you, Puneet. Our guide for this year now for Shield implies an average sequential growth of a little over 10,000 tests quarter-over-quarter. We feel confident about this new guidance. We will capture more data on how DTC campaigns continue to impact volume, how Quest contributes, and how rep productivity improves as we continue to hire reps. Currently, this guide is the right one and we feel very confident about a little over 10,000 quarter-over-quarter growth.

On the 1.3 average repeat use for Guardant360, we see multiple shots on goal to increase repeat testing. The primary pathway is the combination of Guardant360 Liquid and Reveal for monitoring. Reveal will provide a simpler way to reflex patients to a Guardant360 test if and when they progress. This feature is starting to happen now with the launch of Reveal for therapy monitoring, which is showing exciting traction. We're confident that, regardless of how camizestrant turns out, the future of oncology and therapy switching will involve ctDNA.

Next question is from the line of Dan Arias with Stifel.

Helmy, on that point, on the camizestrant AdCom, some of the folks on the committee seemed to suggest that the vote would have been yes if there was an overall survival benefit. From where you sit, are the trials that might be on deck set up endpoint-wise to show that? What do we have coming in terms of evidence generation and getting over the hump on what these folks might need to see?

Yes. We don't want to comment on the specifics of any one trial. We're confident that over time other trials will push the envelope. It's always hard for the first paradigm shift and a mountain of evidence is required when moving paradigms. Once that dam is broken, it's hard to go back. It's a matter of when, not if, and we're confident we'll get there over the next few years, if not sooner.

Next question is from the line of Kyle Mikson with Canaccord.

Congrats on the quarter. Mike, on the ASP for Shield, it looks like the rest of the year ASP implied in the new guide is high $500s. I'm curious what you're assuming in terms of mix and why it would be that low. And a broader question for Helmy: with the acquisition today of an AI-based diagnostics company, are you thinking about ways to step up your AI capabilities and offer AI-based companion diagnostics?

Kyle, I'll take the Shield ASP question first. If you look at our guide on the volume and revenue increase, it implies that for Q2 through Q4 the average ASP is around $775, which is effectively the same guide we gave for that portion of the year in February. So there's no change. As I mentioned before, the tick down from Q1, which was very strong, is driven by the mix of Medicare fee-for-service and Medicare Advantage versus commercial patients where we're not getting paid now.

On the AI question, we've been leading in real AI that provides actionable insights. There's a lot of talk about AI, but physicians vote with their feet when using our products. We were among the first to bring AI pathology to oncology with the Lunit collaboration. You're seeing what we're doing with InfinityAI. We're one of the first to amass large-scale data. Data is the raw fuel to use AI for actionable insights. We built an architecture purpose-built to deploy AI effectively. Over the coming quarters, you'll see us share more of the exciting things we're building with AI and our treasury of data.

Next question is from the line of Tycho Peterson with Jefferies.

A couple of quick ones. On SERENA-6 and therapy monitoring, how does this change timelines for establishing therapy monitoring as a standard billable event versus just therapy selection? Does this extend the adoption curve for other high-volume areas like lung and CRC surveillance? Second, on consolidation and competition with Roche and Abbott, does this change your thoughts on the size of the sales channel or go-to-market strategy? And for Mike, was there any weather impact in Q1? Some have asked if there's a catch-up in Q2.

In terms of SERENA-6, our primary shots on goal are Reveal therapy monitoring and the reimbursement packages we have on deck for IO therapy monitoring and chemotherapy monitoring. With those in place, we'll be in a very good spot for therapy monitoring. Trials like SERENA-6 are upside to that pathway. On consolidation, we think about balancing organic growth with inorganic opportunities. The bar is high for what we've built organically in terms of growth rates and product quality. Any acquisition would need to be accretive to what we've built. Consolidation will happen at some point.

With respect to weather impact, in Q1 we saw normal seasonal impact related to PCP footfall and weather. That was expected and included in our original guide. So the start of the year came in as we expected. We don't anticipate any catch-up; the start of the year was what we normally expect to see every year.

Next question is from the line of Bill Bonello with Craig-Hallum.

A bigger picture question on the importance of the portfolio you've built. Can you give a sense of the percentage of customers ordering multiple products, say Guardant360 Liquid and Tissue and Reveal? With this growth, how much of it is competitive takeaway versus physicians using your products de novo?

Those numbers for multi-product ordering keep increasing every quarter in terms of depth of ordering. It's not just the number of patients where a physician orders a single product, but linked products where there may be a CDx cluster for tissue and physicians may be monitoring those patients or using an MRD product for another patient subset. That's the power of the platform: all these products are linked. Having a comprehensive portfolio means any one best-in-class product can convert users into Guardant advocates. We have roughly 10,000 to 11,000 oncologists ordering from us on a quarterly basis. It's hard to gain share in terms of de novo physicians at this point, so the growth is mostly from greater depth in existing physician relationships and share gains. There's also a longitudinal aspect that remains underpenetrated and will drive growth in coming years.

Next question is from the line of Michael Ryskin with Bank of America.

Congrats on the quarter. There's been a land grab among competitors on market access and expanding sales forces. What are your internal plans for commercial sales force expansion, where are you investing across the portfolio, and where will that incremental OpEx go for the rest of the year?

On the oncology side, we monitor revenue per territory per rep. If there is no saturation, we may split territories, add reps and support staff. That's good commercial hygiene and we'll continue to do that where we see positive ROI. We pride ourselves on strong sales efficiency and will continue to invest in sales and marketing where it's efficient.

On the Screening side, any additional gross profit year-over-year is being reinvested in building the sales and marketing function. That investment is going to hiring additional sales force and marketing campaigns like the DTC campaign. We've continued to hire this year and the quality of reps we've been able to hire continues to improve. We're excited by what we're seeing.

Next question is from the line of Dan Brennan with TD Cowen.

On Guardant360, really nice quarter, 30% volume growth. What was better than you thought to drive that volume growth? And implicit within the new 35% oncology volume growth, how are you thinking about Guardant360? On multi-cancer, remind us of the strategy: when will we learn more? You're collecting samples via opt-ins; what's the timetable for regulatory clarity?

In terms of Guardant360, there wasn't a single surprise. The test is best-in-class with capabilities not available in the market and we continue to push adoption. For the rest of the year, we initially guided something like 20% year-over-year growth for Guardant360. The strong quarter improves our momentum and FDA approval for Guardant360 would be another major catalyst and could be upside to the current forecast. On Multi-Cancer Detection, the opt-in rate is strong. Our strategy is to build the largest clinical database of MCD testing from U.S. patients. We have a couple of milestones to hit to build that database. Let us achieve those milestones and then we'll set expectations for the timing of regulatory milestones. We are pleased with current progress.

Next question is from the line of Brandon Couillard with Wells Fargo.

A few on Shield. How many reps do you expect to have on board exiting the year given the higher revenue guide? Second, do you expect the move to two blood tubes to be a volume driver? Third, on ACS guidelines, why haven't they been published yet? Any feedback from your interactions with the organization?

We entered the year with the roughly 300 reps discussed earlier. Incremental gross profit this year will be reinvested in the sales function. We don't plan to provide pipe-by-pipe updates on sales team size as the field is competitive and that's commercially sensitive. Based on the guide, you can estimate how many reps we may have by the end of 2026. Regarding the two-tube kit, we didn't hear issues with the four-tube kit, but we always aim for the best patient experience. We worked on studies to reduce to two tubes and are pleased to have FDA approval to do so; we'll roll out the updated kit in the near future. On the ACS guideline, our conversations with them have been positive. We believe it is coming, and it appears everything is done; we are just waiting for the finalized guidelines to be published. It should be any day, but we will see.

Final question is from the line of Bradley Bowers with Mizuho.

Can you double-click where you're seeing Reveal volume growth? Pricing doesn't lend itself to Medicare CRC, but based on KOL checks, that area may prefer Tissue. Where are you seeing volume growth ahead of expectations and what should we expect for volume and price lift post-breast?

We're seeing Reveal growth across the board: CRC, breast has been very strong, lung, and therapy monitoring has also been relatively strong. We're the far and away leader in tissue-free MRD and are doubling down on that. We expect to expand Reveal's role and we'll be excited for more informed applications with Reveal later this year.

ASP for Reveal remains in the $600 to $700 range. We're hopeful to get incremental MolDx coverage in the near future with the breast, IO and chemo submissions we've made. Securing Medicare coverage for these would have a positive impact on ASP. Breast is a large portion of the volume now, and getting coverage would move us step-by-step closer to the $1,000 ASP target we set for 2028.

No additional questions are waiting at this time. I'll pass the call back to management for any closing remarks.

That's it. Thank you, Matt.

That concludes the conference call. Thank you for your participation. You may now disconnect your lines.