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. All lines will be muted during the presentation portion of the call with an opportunity for questions and answers at the end. If you would like to ask a question, please press star one on your telephone keypad. I'll now have to pass the conference over to our host, Zarak Khurshid, VP of Investor Relations. Zarek, 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-Chief Executive Officer, AmirAli Talasaz, Co-Chief Executive Officer, and Michael 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 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 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 in 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 and data, and screening business lines.
Taking a closer look at our oncology business in 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 in 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 SmartApps 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 and 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 mode, we uncover novel biological signatures, power new SmartApp 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 review 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 CDK 4/6 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. 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 Liquid Biopsy 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 non-users. 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 SmartApp 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 in 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. 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 a further strengthening of our relationships with leading biopharma companies, including a multi-year 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, Tommy. 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 on approximately 9,000 tests in Q1 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 non-invasive 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. The results exceeded our expectations. Together, these efforts generated over 1 billion impressions. The centerpiece was our partnership with Patrick Dempsey, actor and avid 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 traffics 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. 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. 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. 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 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 tests 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 multi-cancer detection results report. The Shield MCD report is available to Shield CRC patients who authorize 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 finding across nine additional cancer types beyond CRC, including lung, breast, ovarian, pancreatic, and others. We are encouraged by HCP and patient response to this data collection initiatives 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, onto 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 launch 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 and 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-$3,100, Guardant360 Tissue above $2,000, and Reveal between $600-$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 and 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.
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're raising our full-year 2026 revenue guidance to a range of $1.30 billion-$1.32 billion, representing growth of 32%-34%. Oncology revenue is now expected to grow 28%-29%, with volume growth of greater than 35%. Demand fundamentals remain strong across the portfolio. Guardant360 Liquid should continue to benefit from SmartApp 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 and 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-$198 million, driven by Shield volume of approximately 230,000-245,000 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%-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-$1.07 billion, representing growth of 16%-18% compared to 2025. We continue to expect full-year free cash flow burn to be in the range of $185 million-$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'll 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 six to three against the claim that camizestrant demonstrated clinically meaningful benefit in HR-positive, HER2-negative metastatic breast cancer. The FDA retains full discretion over its final decision, and we look forward to that outcome in the coming months.
The committee's discussion reinforced a broader consensus that ctDNA companion diagnostic therapy monitoring represents the future of precision oncology care. 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 and data, we're advancing CDx programs and expanding strategic partnerships, including recent additions with leading biopharma companies and continuing 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. The business is delivering very strong growth, and we remain focused on disciplined execution as we scale. We'll now open the call for questions.
First question is from the line of Mark Massaro with BTIG. Your line is now open.
Hey, guys. Congrats on the strong beat and raise. I'll stick with the Shield question. It's nice to see, you know, both, you know, volumes and revenue come in above my expectations. 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. Can you just give us a sense for why you raised the volume guide for Shield? If I remember this correctly, I believe the prior outlook excluded benefit from Quest. How much of this might be adding Quest into the calculus versus any other drivers that you're seeing?
Thank you, Mark. Yeah, we are very proud of what we did in Q1 in terms of Shield volume. You know, January and February went as we expected. As we entered March, really we saw such a huge momentum that, you know, was way better than actually what we expected. The root cause of it, like, you know, multiple things worked all at the same time, hand to hand. You know, we talked about launching our D2C campaign, influencer campaigns. Quest went live at the same time. You know, that EMR connectivity actually helped in a very meaningful way. We saw that actually continue. Based on the trends that we've seen in March, and, you know, We don't want to get into Q2 commentary, but based on everything that we've seen, gives us a lot of good confidence of what we can deliver in this year.
Still, we don't want to get ahead of our skis and be too excited with maybe what we've seen. You know, we are very confident of this new guide that we put out there. In terms of Quest contribution, you know, we need to capture more data on how much really Quest is helping us incrementally. What we are seeing in terms of early indications are positive. We are counting on some of that in our new guide. Again, in a very thoughtful way. We are gonna monitor how it goes in the months to come. We'll set the expectation accordingly.
Thank you for your question. Next question is from the line of Subbu Nambi with Guggenheim. Your line is now open.
Hey, guys. Thank you for taking my questions. 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 repeat testing or something else? Then as we look to full year guidance, how much of the guidance is attributed to G360 outlook? Thank you
Sure. Thanks a lot for the question. We're very pleased with how, as you said, in its 10th year, Guardant360 continues to grow very nicely. You know, I think a lot of it, I think, you know, when we launched the Smart Liquid Biopsy platform a few years ago, I think a lot of people sort of brushed it off as, you know, just this sort of marginal addition to the liquid biopsy space. This is a fundamental step change in terms of the power of liquid biopsy and its capabilities. It's allowing us to see cancer types. It's allowing us to have all these different capabilities that were never possible with liquid biopsies before. I think you're seeing us lean into that, and you're seeing the adoption begin to grow and grow.
I think it's You know, when we dig in and we peel down another layer, there's certainly, I would say in this inning, a lot of share gains that are happening. There is greater depth and greater breadth as well in terms of physicians that haven't traditionally used liquid biopsy, you know, for certain tumor types. I think all in all, the growth is very broad-based. I think what's even more exciting is that we're still very much in the early innings of the platform's capabilities in terms of what it can do on the SmartApp side as well as the longitudinal testing. I mean, we're still not testing, you know, at every progression, still very under-penetrated. That's the exciting part, is that we're very confident the growth continue, not only in the short term, but the medium to long term as well.
Thank you for your question. Next question is from the line of Patrick Donnelly with Citi. Your line is now open.
Hey, guys. Thank you for taking the questions. Helmy, maybe one for you on the Reveal side. You know, 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? I know you mentioned, you submitted a few data packages to MolDX on breast cancer surveillance and 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. Thank you.
We're very excited with, you know, how fast Reveal is growing, how much depth we're seeing there. Part of the drivers are we're, you know, we're still continuing to see really good growth in CRC, breast, and lung cancers in the surveillance setting. Therapy monitoring's also been a great addition to the portfolio, and we're seeing, I think, great traction there. I think what that shows is really those brands that we've built over the last 12 years in oncology. When we launch something new, we tend to see, I think, outside distraction maybe, versus let's say a new competitor in the market. You know, we're making progress with our MolDX submissions. You know, I think the nice thing is the volume, the sort of leading indicator.
You know, you can't generate revenue without the volume. Hopefully, when we get over the finish line with some of the submissions, then we'll really be in a good spot from a revenue and sort of overall ASP for the MRD business that we have.
Thank you for your question. Next question is from the line of Doug Schenkel with Wolfe Research.
Hi. Thanks for the question. This is Colleen on for Doug Schenkel. We've got a question on Shield ASP expectations. It looks like ASP is holding up a little bit 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 % of Shield volume came from CMS in the quarter and how you expect that to evolve over the year?
And then the comment around-
Yeah, I can take that. You know, Q1 was pretty consistent with what we saw, you know, towards the back end of last year with pretty, you know, high proportion of Shield tests being either Medicare fee-for-service or Medicare Advantage. That's what's been driving that, you know, strong ASP over the last few quarters. You know, as we look out for the remainder of the year, we're expecting to sort of broaden the reach to patients under 65. Of course, you know, we're not covered yet on the commercial side.
I think, you know, our sort of expectation and our guide sort of implies a tick down in the ASP for the remainder of the year as we build out that, you know, commercial patient volume and getting ahead of when we start to get the reimbursement. Yeah, today's been strong. It's predominantly Medicare Advantage, but that sort of mix is gonna skew a little bit more to the under 65s throughout the year.
Thank you for your question. Next question from the line of Casey Woodring with J.P. Morgan. Your line is now open.
Hi, this is Sebastian Sandler on for Casey. Thanks for taking the question. Can you dig a little more into the G360 Tissue growth you're seeing? You're growing well above the market, seems like you're taking some share there. I'm just curious how sustainable maybe some of these share gains are. Can you talk about the pathway to, you know, 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. Thanks.
Yeah, great questions. Obviously we're very pleased with the growth we're seeing in tissue. We think one of the things that will sort of further accelerate that growth is as we get FDA approval for our Guardant360 Liquid test. We think that will really streamline the portfolio, allow simplified ordering between the two products and really help move everything onto the SMART Platform. Yeah, we believe this growth is sustainable. Right, right now, you know, sort of the trajectory is being led by Guardant360 Liquid in terms of just how advanced those capabilities are. The nice thing is that Guardant360 Tissue will also have a lot of the same SmartApps over time.
We think, essentially tissue can just draft behind the really, I think, amazing growth we're seeing with our liquid portfolio. In terms of whole transcriptome, maybe if we take a step back, you know, I think the overall sort of trajectory or, you know, pathway we're seeing with Guardant360 Tissue is that, you know, obviously that will go through its own regulatory pathway. We'll submit that to the FDA at some point. We believe we can qualify for essentially ADLP status there as well, which should improve ASP further substantially.
Thank you for your question. Next question is from the line of Puneet Souda with Leerink Partners. Your line is now open.
Yeah, hi, guys, AmirAli Talasaz and Helmy Eltoukhy. Thanks for taking my question, and Michael Bell as well. First one on Shield, 90% adherence rate, that is impressive, something AmirAli Talasaz, you've been pointing out for some time. Just as you were pointing out FDA approval of Shield and both of those, you know, obviously coming to fruition here. Really like the consistency and insight here. Could you talk about the Shield volume cadence through the year? How should we think about the next 3 quarters, just given the momentum you're seeing and the effort around the key ads and the marketing and all of that you're putting behind DTC Shield? On the oncology side, Helmy Eltoukhy, G three sixty repeat users is important driver.
camizestrant Ad Com was resoundingly positive for G360 and ctDNA use. The problem was the trial design, not the assay. Going forward, how should we think about the, you know, repeat use from 1.3 average? How does that go higher in the future? Thank you.
Yes, thank you, Puneet. You know, our guide for this year now for Shield, when you do the calculation, it kind of implies an average of about maybe a little over 10K sequential growth, like Q-over-Q. As I mentioned earlier, we feel very confident about this new guidance. We'll see how it goes. You know, again, we didn't want to get ahead of our skis. You know, we want to capture more data of how our DTC campaigns are going to continue to impact our volume, how Quest is going to contribute, how much more we can see the rep productivity is going to go up. We continue to hire reps, you know, we have that element too. Currently this new guide, I think is the right guide, that we feel very confident of a little bit over 10K Q-over-Q growth. Yeah.
Yeah. In terms of the 1.3 average that you mentioned on Guardant360, what we see is that there are multiple shots on goal for getting this future that everyone believes in, which is going from biopsies and scans to just using the power of Smart Liquid Biopsy and blood to monitor patients adaptively and dynamically. There are multiple shots on goal there. The primary one is gonna be using really the one-two punch of Guardant360 Liquid and Guardant Reveal for monitoring. As Guardant Reveal ebbs and flows, it'll be a much simpler way to reflex patients to essentially a Guardant360 test when those patients, if and when those patients progress.
We think this, you know, this future will happen. It's starting to happen now with the launch of Reveal for therapy monitoring, which we're seeing exciting traction for. We're very confident that, you know, regardless of how camizestrant turns out, the future of oncology and the future of therapy switching will involve ctDNA.
Thank you for your question. Next question is from the line of Dan Arias with Stifel. Your line is now open.
Hi, guys. Thanks for the questions. Helmy, on that point, on the camizestrant adcom, some of the folks on the committee seemed to suggest that the vote for them would have been a yes if there was an overall survival benefit. You know, from where you sit, are the trials that might be on deck here set up endpoint wise to show that? You know, what do we have coming to us in terms of just evidence generation and getting over the hump there on what these folks might need to see?
Yeah, I mean, obviously, we don't wanna comment, you know, on the specifics of any one trial. Yeah, we're very confident that over time, there are other trials that, you know, I think are gonna sort of push the envelope. It's always hard for the first paradigm shift, and there's always a mountain of evidence that's required from moving from one paradigm, from one modality to another one. Once that dam is broken, it's very hard to go back to the previous paradigm. It's just a matter of when, not if, and we're very confident we'll get there over the next few years, if not sooner.
Thank you for your question. Next question is from the line of Kyle Mikson with Canaccord. Your line is now open.
Hey, guys. Thanks for the questions. Congrats on the quarter. Michael, on the ASP for Shield, and this was touched on earlier, but it looks like the rest of the year ASP implied in the guide, the new guide is, like, high $500s. I'm just curious what you're assuming in terms of mix and, you know, why would it be that low? That's quite low, obviously. Secondly, on maybe just a broader question perhaps, like, I don't know how we would get into this. We have this acquisition today of an AI-based diagnostics company. Does this, I mean, I know it's, like, 1 example, but are you guys thinking about ways to kind of step up your AI game and, you know, offer AI-based companion diagnostics or anything of that sort? Thanks.
Yeah, Kyle, I'll take the Shield ASP question first. No, actually, you know, if you look at our guide, on the, you know, the volume increase and the revenue increase, what it implies is for Q2 through Q4, on average, the ASP is around $775, which is effectively the same sort of guide that we gave for that part of the year, back in February. There's no change. Yeah, as I mentioned before, what's driving that tick down from Q1, which is very strong, is gonna be just the mix of Medicare Advantage versus commercial patients where we're not getting paid now.
In terms of the AI question, I feel like we've been leading the pack, frankly, in terms of real AI that has actionable insight. There's a lot of talk about, you know, AI in the space, but I think you can see physicians voting with their feet when they're using our products, much more than others in the space right now. You know, we are the first to bring AI pathology to the oncology space with the Lunit collaboration we did a few years ago. You're seeing what we're doing with InfinityAI. I think we'll be one of the first to amass an exabyte of data. Data is really the raw fuel that's required to use AI to have truly actionable insights.
We built an architecture that's purpose-built from the ground up to be, you know, really, deployed and utilized, and worked with the AI in a, I think, very fruitful way. Yeah, you're gonna see, I would say over the coming quarters, us, really, sharing a lot more in terms of all the exciting things that we're building with AI, with, you know, enormous treasury of data that we have, inside the company.
Thank you for your question. Next question is from the line of Tycho Peterson with Jefferies. Your line is now open.
Hey, thanks. 2 quick ones. I guess you've had 2 on SERENA-6. Just a different angle, though. You know, how does this change your timelines for establishing therapy monitoring as a standard billable event versus, you know, just therapy selection? Does this kind of extend the adoption curve and other lessons, you know, learned from this trial as we think about other high volume areas like lung and CRC surveillance? That's 1 question. Second is, you know, consolidation that came up in an earlier question. There's been a lot. How are you thinking about competitive landscape? I mean, now you've got Roche with Saga, obviously Abbott with Exact. Just curious if that changes your, you know, thoughts on size of sales channel, go-to-market strategy at all. For Mike, was there any weather impact?
I've had a few people asking if there's gonna be any catch-up in 2Q. Obviously, you grew through it, but was there any headwind from PCP, you know, visit cancellations? Thanks.
In terms of the SERENA-6 question, our primary shots on goal there are frankly the Reveal therapy monitoring we just launched and the reimbursement packages we have on deck in terms of IO therapy monitoring, chemotherapy monitoring, which are really the primary modalities of tools in the oncology therapy space right now. With those two over the finish line, I think we'll be in a very, very good spot from a therapy monitoring point of view. As we said, things like SERENA-6 and specific trials are frankly upside, you know, really to that primary pathway.
In terms of consolidation, you know, we look at almost, you know, I think, every company in the space are always thinking about balancing organic growth with inorganic growth. As you can see, the bar is very high in terms of what we built organically inside the company, the growth rates, the quality of our products, and so on. It really has to be something that is accretive to what we built here. Yeah, I think it's, you know, it'll happen at some point.
Yeah. Then with respect to the weather impact, you know, I mean, in Q1, we saw the normal seasonal impact, you know, related to sort of PCP. Footfall as well as weather. That was expected. That was in our original guide. You know, start of the year came in, yeah, again, as we expected. No, we don't anticipate any catch-up. I think what we saw in the start of the year was just what we would normally expect to see every year.
Thank you for your question. Next question is from the line of Bill Bonello with Craig-Hallum. Your line is now open.
Hey, guys. Thanks. I have maybe a slightly bigger picture question, but that's just sort of getting at the importance of the portfolio that you've built out. Just curious if you can give us some sense of, you know, the percentage of customers that are ordering multiple products, so say Guardant360 Liquid and Guardant360 Tissue and Guardant Reveal. Maybe along with that, with this growth, how much of it is sort of competitive takeaway versus docs that might be using some of these products, let's say de novo?
Yeah, it's a great question. Those are numbers that keep going up every single quarter in terms of the depth of ordering, not just the number of patients that a physician may have where they're ordering, let's say a single product from us. Really the number of essentially linked products we have where, you know, there may be a CDx plus a tissue, and then the physician may be sort of monitoring those patients, or they may be using an MRD product from us for another patient subset. That is really the power of the platform really, this idea that these products are all linked.
I think that is why, you know, having such a comprehensive portfolio is so important, because essentially any one of those products of their best in class can, you know, help convert those users and those physicians who are Guardant evangelists. You know, I would say that, you know, we, for the, like, de novo versus the sort of users. You know, we have something like, I think 10, 11 thousand oncologists who order from us, you know, certainly on a quarterly kind of basis. It's very hard to sort of gain shares in terms of de novo physicians at this point. It's mostly depth.
I would say it's a balance of greater depth in terms of, percentage of patients that are, sort of, where Guardant360 or where Guardant products are being utilized, and then certainly, share gains as well. I think the exciting part is, you know, obviously there's a longitudinal aspect that, we're barely penetrated and which I think will, lead to, I think, growth for the coming years, across the portfolio.
Thank you for your question. Next question is from the line of Michael Ryskin with Bank of America. Your line is now open.
Greg, thanks for the question. Congrats on the quarter again. Maybe sort of a big picture one. You know, there's been a little bit of a land grab among some of your competitors out of market entrants in terms of expanding sales force, building out as they launch new products and as they try to scale their existing products. Just curious what your, you know, internal plans are for commercial sales force, where you're expanding, where you're investing, and just sort of across the portfolio, you know, if you could walk us through the rest of the year, where you see some of that incremental OpEx going. Thanks.
On the oncology side, this has been a matter, of course now for a number of years, where we look at revenue per territory, per rep, and, you know, as long as there's, you know, no saturation in that territory, we may split it. We may add additional reps, additional support staff. That's just a matter of good hygiene for us, and we'll continue to do that where we see positive ROI. You know, I would say that, I think we prided ourselves on, fairly high, maybe, you know, industry-best, sales efficiency. We'll always try to do it in the most efficient way. Yeah, we're not gonna sort of skimp on sales and marketing where there's positive ROI there.
On the screening side, you know, as we talked about it before, any additional gross profit in terms of year-over-year is getting reinvested in building the S&M function. A very good fraction of it goes into hiring additional sales force. Some is going toward these marketing campaigns, like DTC campaign that we talked about earlier. It's kind of very interesting, in fact. You know, I heard from our head of sales, you know, we are continuing to hire this year too, that even the quality of the reps that we are hiring continues to go up. We are very excited with what we are seeing right now.
Thank you for your question. The next question is from the line of Dan Brennan with TD Cowen. Your line is now open.
Great. Thank you. Maybe 1 on Guardant360 and just 1 on multi-cancer. On Guardant360, really nice quarter, 30% volume growth, you know, well above expectations. I know there was a comment question or 2 earlier, but just can you speak to a little bit again, like what was better than you thought to drive that kind of volume growth? And then B, kind of within, implicit within the new 35% oncology volume growth, how are you thinking about Guardant360? Just on multi-cancer, can you just remind us of the strategy there? When we'll learn more? You know, you're obviously having the ability to have patients opt in. You know, what's the timetable at which we, you know, we would get some clarity on the regulatory plan there?
I know you've been bullish about the number of samples you'll be collecting, but, just wondering, you know, how we think about the path forward there. Thank you.
In terms of Guardant360, I don't think there was anything that, you know, kind of, you know, completely surprised us. I mean, I think we know that the test is, you know, really best in class, offers, you know, a lot of capabilities that frankly are not available in the market, and I think we're just continuing to lean into that. When we think about the rest of the year, you know, I think beginning we said, you know, something like 20% year-over-year growth for 360. That's obviously with a strong quarter inching up. We're gonna continue, yeah, pushing the Pro- Vision 360 out there, the FDA approval of 360 should be another major catalyst that hopefully will be even upside to this current forecast.
On the MCD front, you know, this opt-in rate is going strong. With the strategy that we have, we are on track to have the biggest clinical database of MCD testing and the value on the patient from U.S. patient population in near future. Still we have couple milestones to hit to build that database. Let us get there, and then we would set the right expectation for the timing of the regulatory milestones. We are pleased with what we are seeing today.
Thank you for your question. Next question is from the line of Brandon Couillard with Wells Fargo. Your line is now open.
Good afternoon. A couple on Shield. How many reps do you expect to have on board exiting the year at this point in the context of the higher revenue guide? Number 2, do you expect only needing 2 blood tubes to be a volume driver? Number 3, on ACS guidelines, why don't you think they've been published yet? Are you able to share any feedback from maybe some of your interactions with the organization? Thanks.
Yeah. We entered this year with, like, the 300 reps that we talked about. You know, as I mentioned, this incremental gross profit that we're gonna have this year is gonna, you know, get reinvested back. We are not planning to just give like, you know, bite by bite kind of updates on the size of the sales team as, you know, this field is becoming competitive, and that's commercially sensitive information. You know, based on this high-level guide, I think you guys are well positioned to have some estimation of how many people we are gonna have by end of, let's say, 2026. In terms of 2 tubes, you know, on one side, we didn't hear any kind of issue with 4 tube, but we always wanna have the best-in-class, easiest customer experience with Guardant products.
As a result, we worked on studies to reduce the 4 tubes even to 2 tubes, we are very pleased that, you know, we got the approval from FDA, we are going live with that, you know, updated kit in very near future. In terms of ACS guideline, I know you guys are hearing from me, it's coming, it's coming now probably for over 1 year. My answer is the same. I think it's gonna come any day. You know, I've been kind of a broken record on it. Our conversation with them continues to be actually pretty positive and looks like everything is done. We are just waiting for the finalized guideline to be published. It should be any day, we'll see.
Matt, last question, please.
Final questions from the line of Bradley Bowers with Mizuho. Your line is now open.
Hey, there. Thanks for getting me in. Just wanted to maybe double-click on where you're kinda seeing the Reveal volume growth. You know, the pricing doesn't lend itself to be, you know, in Medicare CRC, but maybe I'm wrong. Just based on channel checks, you know, that area may be preferring tissue. Just wanted to see if, you know, where you're kind of seeing some of the volume growth ahead of expectation and maybe what the expectation for volume and price lift should be post-breast. Thank you.
Yeah, I would say, you know, we're seeing growth frankly across the board. We're seeing it CRC, breast, has been very strong for us, lung, and then obviously new indication of therapy monitoring has been relatively strong for us as well. Yeah, I think, you know, I think the market really has, I would say, sort of two parts to it. There really is a tumor-informed sort of MRD subset, and then certainly a tissue-free market as well that is very, very sizable. Right now, we're the far and away leader in tissue-free MRD, and we're continuing to lean into that. Obviously, we'll be excited when we dip our toes into tumor-informed with Reveal coming later this year. I'll let [Naveen] speak about this too.
Yeah, no, ASP, you know, continues to be in this range, $600-$700. I think, you know, we're excited hopefully to get incremental MolDX coverage in the near future with the breast and IO and chemo submissions that we made. Obviously, you know, getting Medicare coverage for the, for each of those is gonna have a nice, positive impact. You know, definitely, breast is a large portion of the volume now. If we get that, you know, it'll definitely take us beyond the current range that we're in and sort of move us step by step closer to the, you know, $1,000 target that we set for 2028.
I think getting that coverage is going to be very positive for us.
Thank you for your question. No additional questions waiting at this time. I'll pass the call back to management for any closing remarks.
No, that's it. Thank you, Matt.
That concludes the conference call. Thank you for your participation. You may now disconnect your lines.