We continued to build momentum across Oncology, Biopharma, and Screening business lines, including accelerating therapy selection and MRD volume growth, record Biopharma sales, and quickly scaling Shield volumes and revenues. Q2 revenue grew 31% year-over-year to $232 million, with strong performance across our Oncology, Screening, and Biopharma & Data businesses. Roughly 1/2 of the overall year-over-year revenue growth in Q2 came from the Oncology business, with revenue increasing 22% to $159 million. Oncology volumes increased 30% year-over-year to approximately 64,000 tests in the second quarter, with the majority of growth driven by Guardant360 Liquid, again closely followed by strong contribution from Reveal.
We saw continued volume growth across all oncology tests this quarter, with particularly strong performance from Guardant360 Liquid, where year-over-year growth accelerated for the fourth consecutive quarter and was over 20% in Q2. We continue to believe that the steady cadence of new app introductions powered by Smart Liquid Biopsy has been instrumental to the accelerating growth profile of Guardant360 Liquid. With a prevalent pool of approximately 40,000 patients in the U.S., this new application of Guardant360 has the potential to drive significant incremental Guardant360 revenue in 2026 and beyond. Since July of last year, Guardant360 has delivered accelerating growth each quarter, fueled by our Guardant Infinity Smart Liquid Biopsy platform.
Our Oncology business is well-positioned for durable growth, supported by continued CGP penetration, favorable ASP dynamics, and international expansion. With our redoubled commercial focus on Reveal following major COGS improvements in Medicare CRC surveillance reimbursement earlier this year, the business is primed for strong growth in MRD. We delivered a record quarter for our Biopharma business, achieving all-time highs in both volume and revenue, with second quarter revenue growing 28% year-over-year. We continue to have a robust and growing pipeline of partnerships, and near-term revenue visibility remains high.
| Metric | Period | Current guidance |
|---|---|---|
| Total revenue | FY2025 | $915M-$925M (approximately 24%-25% growth) (Raised (+$35M)) |
| Oncology revenue growth | FY2025 | approximately 20% (Raised) |
| Total Oncology volume growth | FY2025 | >27% (Raised) |
| Biopharma & Data revenue growth | FY2025 | Mid-teens (Raised) |
| Shield revenue | FY2025 | $55M-$60M (Raised) |
| Shield tests | FY2025 | 68,000-73,000 (Raised) |
| Non-GAAP gross margin | FY2025 | 63%-64% (Raised) |
| Non-GAAP operating expenses | FY2025 | $840M-$850M (11%-12% increase) (Updated) |
| Free cash flow burn | FY2025 | $225M-$235M (improvement from $275M in 2024) (Reaffirmed) |
| Shield ASP | H2 2025 | approximately $800 (slightly below Q2's $900+) (New) |
| Metric | YoY | Note |
|---|---|---|
| Total revenue | +31% to $232.1M | Strong performance across Oncology, Biopharma & Data, and Screening. |
| Oncology revenue | +22% to $158.7M | Accelerated volume growth led by Guardant360 Liquid, closely followed by Reveal. |
| Biopharma & Data revenue | +28% to $56M | Guardant Infinity and additional companion diagnostic partnerships signed in the quarter. |
| Non-GAAP gross margin | +6 pts to 66% | Improved Oncology ASP and turnaround in Reveal and Shield gross margins, both of which moved from negative to positive. |
| Shield gross margin | 48% (vs 2% in Q4 2024) | ADLT-driven Medicare rate increase to $1,495, strong Medicare Advantage reimbursement, and cost per test below $500. |
| Guardant360 Tissue ASP | approximately $2,000 | Medicare pricing increase from $3,140 to $3,500, commercial payer progress, and incremental reimbursement from the new tissue RNA feature. |
| Topic | Previous mention | Current period | Trend |
|---|---|---|---|
| Smart Liquid Biopsy / Infinity platform | Driving accelerating Guardant360 growth since mid-2024 | Nearly a dozen new apps launched at ASCO 2025, expanding clinical utility and driving share gains; over 100,000 genomic profiles across 50+ cancer types | Expanding |
| SERENA-6 / breast cancer monitoring | — | Guardant360 was the exclusive companion liquid biopsy in the trial; a prevalent pool of ~40,000 U.S. patients represents significant incremental revenue opportunity in 2026 and beyond | Emerging tailwind |
| Shield CRC screening | Earlier commercial launch quarters | ~16,000 tests, adherence over 90%, NCCN Category 2A inclusion, sales force to surpass 250 reps by year-end | Scaling |
| Shield multi-cancer detection (MCD) | Clinical validation presented at AACR/ASCO | FDA breakthrough device designation received; NCI Vanguard Study commenced with MCD results being delivered to physicians | Advancing |
| Reveal MRD | Cost per test over $1,000 in 2024 | Fastest-growing oncology product; cost per test below $500; breast reimbursement submitted to MolDX; ASP $600-$700; ADLT submitted and pending | Accelerating |
| Path to profitability | 2028 breakeven target set at prior Investor Day | Reaffirmed 2028 company-wide breakeven; non-Screening business to reach free cash flow breakeven in Q4 2025; ~$200M annual Screening burn | On track |