Guardant Health delivered $302 million of first quarter revenue, up 48% year-over-year - its fastest growth in five years - with broad-based strength across oncology, biopharma and data, and screening, surpassing the $1 billion trailing-twelve-month revenue milestone. Shield screening revenue surged to $42 million from $6 million a year earlier, accelerating sharply in March on DTC campaigns and the Quest partnership, prompting a raised full-year guide; adjusted EBITDA loss was flat at $59 million. The main risks flagged were an adverse ODAC vote on camizestrant affecting a potential ESR1 monitoring launch and an expected Shield ASP decline as mix shifts toward not-yet-covered under-65 commercial patients.
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.
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 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 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 InfinityAI powering a steady cadence of new clinical applications that are driving deeper adoption among oncologists. We have a strong pipeline of additional Smart Apps in development, and we look forward to continuing that cadence. Reveal remained our fastest-growing product, with volumes up over 100% year-over-year, reflecting strong adoption of Reveal 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 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 epigenetic profiles across more than 100 tumor types, and each new sample helps compound the breadth and uniqueness of what we can deliver over time.
By applying our InfinityAI learning engine to this expanding data moat, we uncover novel biological signatures, power new Smart Apps 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 the MolDX submission for CDK 4/6 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. 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 Apps 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+, HER2-, 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, 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 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 two 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-$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 Smart Apps 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+, HER2- 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.