Guardant Health, Inc.

Guardant Health, Inc.

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Q1 FY2026 · Earnings Call TranscriptMay 7, 2026

Operator

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 pass the conference over to our host, Zarak Perchemlides, VP of Investor Relations.

Zarak, please go ahead.

Zarak Khurshid

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 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.

Helmy Eltoukhy

Thanks, Zarak. Good afternoon, and thank you for joining our first quarter 2026 earnings call.

Starting on slide three, 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 five 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 test. 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 in slide four, 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 five, 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 three 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 six, 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 Infinity AI 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 seven, 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 epigenomic 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 Infinity AI 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 eight 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 a MolDx submission for CDK4/6 inhibitor monitoring.

Looking further ahead, we have ongoing studies across more than five 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 nine, 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 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 smart app data was remarkable.

25 of the abstracts featured Infinity AI generated findings, which speaks to how rapidly this platform is maturing. We were particularly encouraged to see concrete evidence of Infinity AI 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 and 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, and this week's CDx FDA approval with Arvinas and Pfizer's vepdegestrant for ER-positive, HER2-negative, ESR1-mutated advanced breast cancer. Our CDx franchise now spans 26 approvals across the US, Japan, and Europe, backed by a robust pipeline across multiple partnerships with leading biopharma companies.

In the quarter, real-world evidence generated from Infinity AI 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 Infinity AI 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.

AmirAli Talasaz

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 sustain 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 D2C 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 multicancer 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 D2C 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 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 traffic and consumer-initiated provider engagements, which we expect to translate into greater adoption of Shield.

Turning to slide 15, complementing our D2C 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, the official launch of 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's 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 tests to two tubes from the original four-tube kit. We applaud the FDA for their continued 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 multicancer detection platform.

When a physician orders Shield for CRC screening, they can opt in to receive multicancer 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 multicancer detection. The MCD report covers findings 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 multicancer detection outcomes from patients in the United States.

Now on to slide 18, during Q1, we announced the expansion of Shield multicancer 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.

Mike Bell

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 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 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, and following the launch of our Quest partnership and successful HCP and D2C 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 the 1st, 2025, following Shield's ADLT designation. As a reminder, after the initial nine-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 D2C 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 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 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 D2C and HCP campaigns, and the launch of our Quest collaboration, we now expect screening revenue of $186 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 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 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'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 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 diagnostics therapy monitoring represents the future of precision oncology care.

Furthermore, our revenue guidance does not reflect any impact from a 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 continue to scale our Infinity AI platform. In screening, we've launched our Quest collaboration and expanded Shield into multicancer 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.

If you'd like to ask a question, please press star followed by one on your telephone keypad. If for any reason you'd like to remove that question, please press star followed by two.

Again, to ask a question, press star one. As a reminder, if you're using a speakerphone, please remember to pick up your handset before asking your question.

We'll pause here briefly as questions register.

Operator

First question is from the line of Mark Massaro with BTIG. Your line is now open.

Mark Massaro

Hey guys. Congrats on the strong beat and raise.

I'll stick with a Shield question. It's nice to see both volumes and revenue come in above my expectations.

You talked about volumes accelerated momentum in March. 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?

AmirAli Talasaz

Thanks, Mark. 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, really we saw such a huge momentum that was way better than actually what we expected. The root cause of it, multiple things worked all at the same time hand to hand.

We talked about launching our D2C campaign, influencer campaigns, Quest went live at the same time, that EMR connectivity actually helped in a very meaningful way. We saw that actually continue.

Based on the trend that we've seen in March, and 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, but we are very confident about this new guide that we put out there.

In terms of Quest contribution, 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, but again, in a very thoughtful way, and we're going to monitor how it goes in the months to come and we've set the expectation accordingly.

Operator

Thank you for your question. Next question is from the line of Subbu Nambi with Guggenheim.

Your line is now open.

Subbu Nambi

Hey guys, thank you for taking my questions. Congratulations on the prints.

Helmy, G360, 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 guide raise is attributed to G360 outlook? Thank you.

Helmy Eltoukhy

Thanks for the question. We're very pleased with how, as you said, in its 10th year, Guardant360 continues to grow very nicely.

When we launched the smart liquid biopsy platform a few years ago, I think a lot of people sort of brushed it off as just a sort of marginal addition to the liquid biopsy space. It's a fundamental step change in terms of the power of liquid biopsy and its capabilities, allowing us to see phenotype, allowing us to have all these different capabilities that were never possible with liquid biopsy before, and I think you're seeing us lean into that and you're seeing adoption begin to grow and grow.

I think, 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 a greater breadth as well in terms of physicians that haven't traditionally used liquid biopsy 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 smart app side as well as the longitudinal testing.

We're still not testing at every progression, still very underpenetrated. That's the exciting part is that we're very confident in the growth continuing not only in the short term, but the medium to long term as well.

Operator

Thank you for your question. Next question is from the line of Patrick Donnelly with Citi.

Your line is now open.

Patrick Donnelly

Hey guys, thank you for taking the questions. 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?

Then I know you mentioned you submitted a few data packages to MolDx on breast cancer surveillance, 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? Thank you.

Helmy Eltoukhy

We're very excited with how fast Reveal is growing, how much depth we're seeing there. Part of the drivers are we're still continuing to see really good growth with CRC, breast, and lung cancers in the surveillance setting.

Therapy monitoring has also been a great addition to the portfolio and we're seeing I think great traction there. I think what that shows is really this brand that we've built over the last 12 years in oncology.

When we launch something new, we tend to see, I think, outsized traction, maybe versus, let's say, a new competitor in the market. Then we're making progress with our MolDx submissions.

I think the nice thing is the volume is a sort of leading indicator. You can't generate revenue without the volume, and hopefully when we get over the finish line with some of these 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.

Operator

Thank you for your question. Next question is from the line of Doug Schenkel with Wolfe Research.

Your line is now open.

Colleen Babington

Hi, thanks for the question. This is Colleen on for Doug.

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 '26 Shield ASPs a bit north of $800 per test. If possible, could you share what percentage of Shield volumes came from CMS in the quarter and how you expect that to evolve over the year?

Mike Bell

I can take that. Q1 was pretty consistent with what we saw towards the back end of last year with a pretty high proportion of Shield tests being either Medicare fee-for-service or Medicare Advantage.

That's what's been driving that strong ASP over the last few quarters. 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, we're not covered yet on the commercial side. I think 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 commercial patient volume and getting ahead of when we start to get the reimbursement.

Today it's been strong. It's predominantly Medicare, Medicare Advantage, but that sort of mix is going to skew a little bit more to the under 65 throughout the year.

Operator

Thank you for your question. Next question is from the line of Casey Woodring with J.P.

Morgan. Your line is now open.

Sebastian Sandler

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. Then 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. Thanks.

Helmy Eltoukhy

Great questions. Obviously we're very pleased with the growth we're seeing in tissue, and 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, and we think that will really streamline the portfolio, allow simplified ordering between the two products, and really help move everything onto the smart platform.

We believe this growth is sustainable. Right now, sort of the trajectory is being led by Guardant360 Liquid in terms of just how advanced those capabilities are, but the nice thing is that 360 Tissue will also have a lot of the same smart apps over time, and so 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, I think the overall sort of trajectory or pathway we're seeing with 360 Tissue is that, obviously that will go through its own regulatory pathway. We will submit that to FDA at some point, and we believe we can qualify for essentially ADLT status there as well, which should improve ASP further substantially.

Operator

Thank you for your question. Next question is from the line of Puneet Souda with Leerink Partners.

Your line is now open.

Puneet Souda

Yeah. Hi, guys.

AmirAli and Helmy, thanks for taking my question, and Mike as well. First one on Shield, 90% adherence rate, that is impressive.

Something, AmirAli, you've been pointing out for some time just as you were pointing out FDA approval of Shield and both of those 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 three quarters just given the momentum you're seeing and the effort around the TV ads and the marketing and all of that D2C that you're putting behind Shield?

On the oncology side, Helmy, G360 repeat use is an important driver. Cami-ad Comm was resoundingly positive for G360 and ctDNA use, but the problem was the trial design, not the assay.

Going forward, how should we think about the repeat use from 1.3 average? How does that go higher in the future?

Thank you.

AmirAli Talasaz

Yes. Thank you, Puneet.

Our guide for this year now for Shield, when you do the calculation, kind of implies an average of about maybe a little bit over 10k sequential growth Q-over-Q. As I mentioned earlier, we feel very confident about this new guidance, and we'll see how it goes.

Again, we didn't want to get ahead of our skis, and we want to capture more data of how our D2C 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, we have that element, too, but 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.

Helmy Eltoukhy

In terms of the 1.3 average that you mentioned on 360, I think what we see is that there are multiple shots on goal for getting, I think, 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, dynamically. There are multiple shots on goal there.

I think the primary one is going to be using really the one-two punch of Guardant360 Liquid and Reveal for monitoring. Then as Reveal ebbs and flows, it'll be a much simpler way to reflex patients to essentially a 360 test if and when those patients progress.

We think 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 regardless of how camizestrant turns out, the future of oncology, the future of therapy switching will involve ctDNA.

Operator

Thank you for your question. Next question is from the line of Dan Arias with Stifel.

Your line is now open.

Dan Arias

Hi, guys. Thanks for the questions.

Helmy, on that point on the camizestrant AdCom, some of the folks on the committee seem to suggest that the vote for them would have been a yes if there was an overall survival benefit. From where you sit, are the trials that might be on deck here set up endpoint-wise to show that?

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?

Helmy Eltoukhy

Obviously we don't want to comment the specifics of any one trial, but yeah, we're very confident that over time there are other trials that I think are going to 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 for moving 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.

Operator

Thank you for your question. Next question is from the line of Kyle Mikson with Canaccord.

Your line is now open.

Kyle Mikson

Hey, guys. Thanks for the questions.

Congrats on the quarter. Mike, on the ASP for Shield, this was touched on earlier, but it looks like the rest of the year ASP implied in the new guide is high $500s.

I'm just curious what you're assuming in terms of mix and why would it be that low? That's quite low, obviously.

Then secondly, on maybe just a broader question perhaps Helmy can answer this, we have this acquisition today of an AI-based kind of diagnostics company. I know it's one example, but are you guys thinking about ways to kind of step up your AI game and offer AI-based companion diagnostics or anything of that sort?

Thanks.

Mike Bell

Kyle, I'll take the Shield ASP question first. No, actually, if you look at our guide on 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. As I mentioned before, what's driving that tick down from Q1, which is very strong, is going to be just the mix of Medicare, Medicare Advantage versus commercial patients where we're not getting paid now.

Helmy Eltoukhy

In terms of the AI question, I feel like we've been leading the pack frankly in terms of real AI that has actionable insights. There's a lot of talk about AI in this 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.

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 Infinity AI.

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've built an architecture that's purpose-built from the ground up to be really deployed and utilized and worked with the AI in a I think very quick way. You're going to 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 the enormous treasury of data that we have inside the company.

Operator

Thank you for your question. Next question is from the line of Tycho Peterson with Jefferies.

Your line is now open.

Tycho Peterson

Hey, thanks. A couple quick ones, I guess.

You've had a couple on SERENA-6, just a different angle, though. How does this change your timelines for establishing therapy monitoring as a standard billable event versus just therapy selection?

Does this kind of extend the adoption curve? Are there lessons learned from this trial as we think about other high-volume areas like lung and CRC surveillance?

That's one question. Second is consolidation.

It came up in an earlier question. There's been a lot.

How are you thinking about competitive landscape? Now you've got Roche with Saga, obviously Abbott with Exact.

Just curious if that changes your thoughts on size of sales channel, go-to-market strategy at all. Then from Mike, was there any weather impact?

I've had a few people asking if there's going to be any catch-up in 2Q. Obviously, you grew through it, but was there any headwind from PCP visit cancellations?

Thanks.

Helmy Eltoukhy

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 therapies in 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 really to that with a primary pathway. In terms of consolidation, we look at almost, I think every company in the space, always thinking about balancing organic growth with inorganic growth, but as you can see, the bar is very high in terms of what we've 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've built here. I think it'll happen at some point.

Mike Bell

Yeah. Then with respect to the weather impact, yeah, in Q1, we saw the normal seasonal impact related to sort of PCP footfall as well as weather.

That was expected. That was in our original guide.

The 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.

Operator

Thank you for your question. Next question is from the line of Bill Bonello with Craig-Hallum.

Your line is now open.

Bill Bonello

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 the percentage of customers that are ordering multiple products, say 360 Liquid and Tissue and Reveal.

Then 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?

Helmy Eltoukhy

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, but really the number of essentially linked products we have where 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 really is the power of the platform, really this idea that all these products are all linked. I think that is why having such a comprehensive portfolio is so important because essentially any one of those products if they're best-in-class can help convert those users and those physicians to Guardant evangelists.

I would say that for the de novo versus the sort of users, we have something like, I think, 10, 11,000 oncologists who order from us, certainly on a quarterly kind of basis. It's very hard to sort of gain shares in terms of de novo positions at this point.

It's mostly depth, I would say it's a balance of greater depth in terms of percentage of patients where Guardant360 or Guardant products are being utilized and then certainly share gains as well. Then I think the exciting part is obviously there's a longitudinal aspect that we're barely penetrated in and which I think will lead to I think growth for the coming years across the portfolio.

Operator

Thank you for your question. Next question is from the line of Michael Ryskin with Bank of America.

Your line is now open.

Michael Ryskin

Great. Thanks for the question.

Congrats on the quarter again. Maybe sort of a big picture one.

There's been a little bit of a land grab among some of your competitors, other market entrants in terms of expanding sales force, build it out as they launch new products and as they try to scale their existing products. Just curious what your internal plans are for commercial sales force, where you're expanding, where you're investing, just sort of across the portfolio, if you could walk us through the rest of the year, where you see some of that incremental OpEx going.

Thanks.

Helmy Eltoukhy

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 as long as there's no saturation in that territory, when they 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.

I would say that I think we've prided ourselves on fairly high and maybe industry-best sales efficiency, and so we'll always try to do it in the most efficient way, but yeah, we're not going to sort of skimp on sales and marketing where there's positive ROI there.

AmirAli Talasaz

On screening side, 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. Very very good fraction of it goes into hiring additional sales force, some is going toward this marketing campaigns like D2C campaign that we talked about earlier.

It's kind of very interesting, in fact, I heard from our head of sales, 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.

Operator

Thank you for your question. Next question is from the line of Dan Brennan with TD Cowen.

Your line is now open.

Dan Brennan

Great. Thank you.

Maybe one on G360 and just one on multicancer. On G360, really nice quarter, 30% volume growth, well above expectations.

I know there was a question or two earlier, but just can you speak to a little bit again what was better than you thought to drive that kind of volume growth and then implicit within the new 35% oncology volume growth, how are you thinking about G360? Then just on multicancer, could you just remind us of the strategy there, when we'll learn more?

You're obviously having the ability to have patients opt in. What's the timetable at which 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 how we think about the path forward there. Thank you.

Helmy Eltoukhy

In terms of G360, I don't think there was anything that kind of completely surprised us. I think we know that the test is really best-in-class, offers 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, I think beginning we said, something like 20% year-over-year growth for 360, that's obviously with this strong quarter inching up and we're going to continue, yeah, pushing G360 out there. The FDA approval of 360 should be another major catalyst that hopefully will be even upside to this current forecast.

AmirAli Talasaz

On the MCD front, this opt-in rate is going strong and with this strategy that we have, we are on track to have the biggest clinical database of MCD testing and the value on the patient from US patient population in near future. Still we have a couple milestones to hit to build that database, let us get there, and then we will set the right expectation for the timing of the regulatory milestones, but we are pleased with what we are seeing today.

Operator

Thank you for your question. Next question is from the line of Brandon Couillard with Wells Fargo.

Your line is now open. Hey,

Brandon Couillard

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 two, do you expect only needing two blood tubes to be a volume driver?

Number three, 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.

AmirAli Talasaz

We entered this year with the 300 reps that we talked about, and as I mentioned, this incremental gross profit that we're going to have this year is going get reinvested back. We are not planning to just give bite-by-bite kind of updates on the size of the sales team as this field is becoming competitive and that's commercially sensitive information.

Based on this high-level guide, I think you guys are well-positioned to have some estimation of how many people we're going to have by end of, let's say, 2026. In terms of two tubes, on one side we didn't hear any kind of issue with four tube, but we always want to have the best-in-class, easiest customer experience with Guardant products.

As a result, we worked on studies to reduce the four tubes even to two tube, and we are very pleased that we got the approval from FDA, and we are going live with that updated kit in very near future. In terms of ACS guideline, I know you guys are hearing from me, it's coming now probably for over a year, and my answer is the same.

I think it's going to come any day, but 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're just waiting for the finalized guideline to be published.

It should be any day, but we'll see.

Helmy Eltoukhy

Matt, last question, please.

Operator

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

Bradley Bowers

Hey there, thanks for getting me in. Just wanted to maybe double-click on where you're kind of seeing the Reveal volume growth.

The pricing doesn't lend itself to be in Medicare CRC, but maybe I'm wrong, just based on KOL checks, that area maybe preferring tissue. Just wanted to see where you're kind of seeing some of the volume growth ahead of expectation, maybe what the expectations for volume and price lift should be post-breast.

Thank you.

Helmy Eltoukhy

I would say we're seeing growth frankly across the board. 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.

I think the market really has I would say sort of two parts to it. There 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, and obviously we'll be excited when we dip our toes into tumor-informed with Reveal Ultra coming later this year. I'll let maybe Mike speak about ASP.

Mike Bell

No, ASP continues to be in this range, $600 to $700. I think 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, getting Medicare coverage for each of those is going to have a nice positive impact. Definitely breast is a large portion of the volume now, and so if we get that, it'll definitely take us beyond the current range that we're in and sort of move us step-by-step closer to the $1,000 target that we set for 2028.

I think getting that coverage is going to be very positive for us.

Operator

Thank you for your question. No additional questions waiting at this time, I'll pass the call back to management for any closing remarks.

Helmy Eltoukhy

No, that's it. Thank you, Matt.

Operator

That concludes the conference call. Thank you for your participation.

You may now disconnect your lines.