Starting on slide three, Q3 was an exceptional quarter for Guardant Health, with broad-based growth across our business. Technology volumes grew 40% as year-over-year volume growth continued to accelerate, driven by Guardant360 Liquid, Guardant360 Tissue, and Reveal. Our biopharma business grew nicely year over year with positive CDx momentum, and screening volume accelerated with a sequential increase of 8,000 Shield tests. Importantly, screening has started to generate meaningful revenue, tracking at an annual run rate of approximately $100 million, roughly one year into the commercial launch of the FDA-approved product.
Overall, we are very pleased with our performance this quarter, delivering 39% year-over-year revenue growth and crossing over $1 billion in annualized revenue for the first time. Excluding screening, we reached a major milestone, with the rest of the business becoming cash flow positive one quarter earlier than expected. Now turning to top-line performance in slide four, Q3 revenue grew 39% year over year to $265 million, with strong performance again across our oncology, screening, and biopharma and data businesses. Taking a closer look at our oncology business on slide five, oncology revenue increased 31% to $184 million, and oncology volumes increased 40% year over year to approximately 74,000 tests in the third quarter.
In addition to Guardant360 Liquid, Guardant360 Tissue and Reveal volumes also experience strong year-over-year growth. Looking more closely at some of the recent highlights within our oncology business on slide nine, Guardant360 volume grew exceptionally, with more than 30% year-over-year growth. Turning to slide 10 to take a closer look at our Reveal data pipeline. Turning now to slide 11, I'm proud of the progress we have made over the last few years in both driving demand and revenue growth across our portfolio.
| Metric | Period | Current guidance |
|---|---|---|
| Full year 2025 total revenue | FY2025 | $965M-$970M (~31% growth) (Raised for the third time this year) |
| Oncology revenue growth | FY2025 | ~25% (Raised) |
| Total oncology test volume growth | FY2025 | >30% (Raised) |
| Shield revenue | FY2025 | $71M-$73M (Raised) |
| Shield test volume | FY2025 | 80,000-82,000 tests (Raised) |
| Biopharma and data revenue growth | FY2025 | mid-teens (Unchanged (on track)) |
| Non-GAAP gross margin | FY2025 | 64%-65% (Raised) |
| Non-GAAP operating expenses | FY2025 | $865M-$875M (14%-16% increase vs 2024) |
| Free cash flow burn | FY2025 | $225M-$235M (improvement from $275M in 2024) (Reaffirmed) |
| Company-wide cash flow breakeven | By end of 2027 | Committed to breakeven by end of 2027 (Reaffirmed) |
| Metric | YoY | Note |
|---|---|---|
| Total revenue | +39% to $265.2M | Strong performance across oncology, biopharma and data, and screening businesses. |
| Oncology revenue | +31% to $184.4M | Another quarter of accelerated test volume growth, with approximately 74,000 oncology tests (+40%). |
| Guardant360 Liquid volume | +more than 30% | Expanding clinical utility enabled by smart apps launched over the past year; fifth consecutive quarter of accelerating growth. |
| Biopharma and data revenue | +18% to $54.7M | Continued strong performance including milestone revenue from two companion diagnostic approvals achieved during the quarter. |
| Screening (Shield) revenue | $24.1M from 24,000 tests | ASP of approximately $880, above expectations, reflecting continued focus on Medicare-covered patients, plus ~$3M out-of-period revenue from better-than-expected Medicare Advantage reimbursement. |
| Non-GAAP gross margin | 66% vs 63% | Significant reduction in Reveal COGS (from over $1,000 to under $500 per test) and strong progress in Shield gross margin. |
| Adjusted EBITDA loss | $45.5M loss, improved $10.7M from $56.2M loss | Operating leverage despite continued investment in screening commercial infrastructure. |
| Free cash flow burn | $45.8M, improved $9.5M | Disciplined cash management; core business excluding screening turned free cash flow positive. |
| Topic | Previous mention | Current period | Trend |
|---|---|---|---|
| Shield commercial infrastructure scale-up | Original plan | Accelerated build-out beyond original plan, plus partnerships with Quest Diagnostics (650,000 clinician/hospital accounts, available Q1 2026) and Path Group (250+ health systems across 25 states) | Expanding |
| Smart apps platform on Guardant360 Liquid | Introduced July last year | 15 smart apps launched to date with dozens more in development across Liquid, Tissue, and Reveal | Expanding |
| Reveal MRD franchise | CRC surveillance Medicare coverage achieved early this year | Submitted dossiers for breast surveillance and IO therapy monitoring; planning chemo and CDK4/6 submissions; introducing Reveal Ultra tumor-informed assay | Expanding |
| Shield Multicancer Detection (MCD) | Investor day data (9,251 individuals, 99% specificity, 41% PPV) | Now available nationwide through clinical data collection initiative, expected to reach hundreds of thousands of participants | Expanding |
| Companion diagnostic (CDx) momentum | — | Two additional CDx approvals in Q3 (Guardant360 CDx for ESR1 breast cancer; Japan approval for HER2 NSCLC), reaching 23 total CDx approvals | Expanding |
| American Cancer Society guideline inclusion for Shield | — | Research team appears nearly done; company optimistic about near-future inclusion but not counting on it in guidance | Pending |
| Tests per patient / longitudinal testing | One test per patient per lifetime | Estimated at maturation 4-5 tests per patient per year (more than 10x current market) | Growing |