Guardant Health (NASDAQ:GH) reported what executives described as a “breakout year” in 2025, driven by expanding capabilities across its oncology, screening, and biopharma/data businesses and continued progress toward profitability.
On the company’s fourth-quarter 2025 earnings call, management highlighted strong revenue growth, improving non-GAAP margins, and accelerating adoption of key products including Guardant360, Reveal, and Shield. The company also issued 2026 revenue guidance of $1.25 billion to $1.28 billion and reiterated a longer-term focus on reaching company-wide cash flow breakeven by the end of 2027.
Q4 and full-year 2025 results
Management attributed the performance to “broad-based growth” across oncology, screening, and the biopharma and data segment. The company reported non-GAAP gross margin of 66% in Q4, up from 63% a year earlier, and 66% for the full year, up from 62% in 2024.
Adjusted EBITDA loss narrowed to $64.9 million in Q4 from $78.4 million in the prior-year quarter. For the full year, adjusted EBITDA loss improved to $220.9 million versus $257.5 million in 2024.
Chief Financial Officer Mike Bell said free cash flow burn was $233 million in 2025, an improvement of $42 million and in line with guidance. Excluding screening, the “core business” generated positive free cash flow in both Q3 and Q4, and the company expects the core business to be free cash flow positive for the full year 2026.
Oncology growth driven by Smart Platform and Reveal expansion
Guardant reported oncology revenue of $189.9 million in Q4, up 30% year over year, with oncology test volumes rising 38% to approximately 79,000. For the full year, oncology revenue increased 26% to $683.6 million, and volumes grew 34% to approximately 276,000 tests.
Executives pointed to increasing adoption of the company’s Smart Platform applications as a key driver for Guardant360 Liquid volumes, alongside traction for Guardant360 Tissue following a product upgrade introduced in the second quarter of 2025. Bell said average selling prices were stable sequentially in Q4, with Guardant360 Liquid in the range of $3,000 to $3,100, Guardant360 Tissue at approximately $2,000, and Reveal between $600 and $700.
Reveal remained the company’s “fastest-growing” oncology product, with management citing Medicare reimbursement for colorectal cancer (CRC) surveillance received in the first quarter of 2025 and ongoing strength in breast and lung cancer. In the fourth quarter, Guardant launched Reveal for therapy monitoring, expanding the test beyond minimal residual disease (MRD) surveillance into late-stage therapeutic response monitoring. Co-CEO Helmy Eltoukhy said the opportunity is “synergistic” with Guardant360 because therapy monitoring could bridge patients to subsequent Guardant360 testing when treatment decisions change.
Guardant also discussed its reimbursement efforts for additional Reveal use cases, noting submissions to MolDX to support coverage in breast cancer surveillance, immuno-oncology monitoring, and chemotherapy monitoring. Eltoukhy said reimbursement wins for immunotherapy and chemotherapy monitoring could become “a very important driver for growth over the next few years” for oncology.
Looking ahead, management said it expects Reveal Ultra to launch in 2026, with Eltoukhy saying the company believes the test’s “true clinical sensitivity” will be best in class in the tumor-informed MRD space, though he did not provide details beyond saying to “stay tuned” for more information later in the year.
Screening: Shield ramps, partnerships expand reach
In screening, Guardant reported $35.1 million of Shield revenue in Q4, generated from approximately 38,000 tests, up from 24,000 tests in Q3. For the full year 2025—Shield’s first full calendar year since launch—screening revenue was $79.7 million on approximately 87,000 tests.
Co-CEO AmirAli Talasaz said Shield’s launch has exceeded expectations and described it as “the most successful diagnostic launch in history outside of COVID testing.” The company emphasized real-world adherence, reporting a 93% completion rate across the first 100,000 Shield tests ordered, which management contrasted with typical adherence ranges of 25% to 71% for other screening modalities.
The company said Shield benefited from ADLT status and a $1,495 reimbursement rate, and Talasaz noted that rate has been incorporated into the clinical lab fee schedule and is secured through December 2027.
Guardant also highlighted commercialization initiatives and partnerships intended to broaden access:
- TRICARE coverage for eligible average-risk individuals aged 45 and older, with no copay for active duty service members and their families.
- Health system integrations in West Virginia and Georgia, which management said include full EMR integration and workflow deployment.
- Quest Diagnostics collaboration intended to provide access to Quest’s national sales organization and allow ordering and results through the Quest Connectivity System; the company said it expects to launch later in the quarter.
- PathGroup collaboration that went live in Q4 and expands Shield’s reach to more than 250 health systems across 25 states.
Talasaz said Guardant exited 2025 with approximately 300 sales reps and plans to continue investing incremental screening gross profit into additional sales and marketing buildout in 2026, though management did not provide a year-end headcount target.
On demand mix, Talasaz said the company remains focused on “unscreened” patients and cited internal analysis indicating about 90% of Shield-tested patients had not been screened in at least the prior five years based on available medical records and claims. He added that care-gap closure programs are not currently part of Shield’s growth, noting Shield is not yet qualified for quality scores such as HEDIS and that achieving that could be a “huge additional growth driver.”
2026 outlook: revenue growth, improving cash flow, and product catalysts
For 2026, Guardant guided to total revenue of $1.25 billion to $1.28 billion, representing 27% to 30% growth. The company expects:
- Oncology revenue growth of 25% to 27%, supported by approximately 30% volume growth. Management said guidance excludes potential upside from SERENA-6 ESR1 monitoring, potential FDA approval of Guardant360 Liquid CDx, and the launch of Reveal Ultra.
- Screening revenue of $162 million to $174 million on 210,000 to 225,000 tests, with sequential volume increases expected each quarter and larger increases toward the back half of the year due to seasonality, sales ramp, and EMR expansion through Quest and PathGroup.
- Non-GAAP gross margin of 64% to 65%, reflecting operational improvements and product mix.
- Non-GAAP operating expenses of $1.03 billion to $1.05 billion, up 14% to 16%, with incremental investment primarily directed to screening sales and marketing.
- Free cash flow burn of $185 million to $195 million, with the business excluding screening expected to be free cash flow positive for the full year.
Bell also discussed cost initiatives, including a transition of Guardant360 Liquid to NovaSeq X, which he said should be fully implemented by around mid-2026. He suggested the move could improve Guardant360 gross margin by roughly 200 basis points, from the high 60% range into the low 70% range.
Guardant ended 2025 with approximately $1.3 billion in cash following the MetaSyte Diagnostics acquisition and a November equity and convertible debt financing. The company acquired MetaSyte for $59 million in upfront cash plus up to $90 million in contingent consideration tied to future commercial and regulatory milestones, with management describing it as a complementary technology that could enhance CRC screening, multi-cancer detection, and broader oncology efforts.
About Guardant Health (NASDAQ:GH)
Guardant Health, Inc is a precision oncology company specializing in blood-based cancer diagnostics. Founded in 2012 and headquartered in Redwood City, California, the company develops non-invasive tests that use circulating tumor DNA (ctDNA) to profile genomic alterations in patients with solid tumors. Guardant Health’s mission is to advance cancer care by providing actionable data to clinicians, pharmaceutical partners and researchers worldwide.
The company’s flagship product, Guardant360, is a next-generation sequencing (NGS) assay designed to detect mutations, copy number variations and select fusions in more than 70 cancer-related genes.
