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Guardant Health, Inc. (GH): Business Model Canvas [Dec-2025 Updated] |
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Guardant Health, Inc. (GH) Bundle
You're digging into Guardant Health, Inc.'s strategy as they push hard on the Shield launch, and frankly, understanding the nuts and bolts of their business model is key to seeing where the next dollar comes from. As someone who's spent two decades mapping out these complex biotechs, I can tell you the 2025 picture is tight: they are guiding total revenue toward $965 million to $970 million while spending heavily on scaling, with non-GAAP operating expenses hitting $865 million to $875 million. This canvas cuts through the noise, showing exactly how their core liquid biopsy tests, like Guardant360 and the new Shield screening product, connect with biopharma partners and drive that projected 64% to 65% gross margin. Dive in below to see the nine blocks that define their current fight for market position.
Guardant Health, Inc. (GH) - Canvas Business Model: Key Partnerships
You're looking at how Guardant Health, Inc. scales its complex diagnostics and data platforms. The key partnerships aren't just nice-to-haves; they are the essential infrastructure for getting Shield into the hands of patients and integrating their data into drug development pipelines. Honestly, without these anchors, the growth projections just don't hold up.
Diagnostic Lab Networks for Shield Distribution
Getting the Shield test, which is the first and only blood test to receive full FDA approval as a primary screening option for colorectal cancer in average-risk adults aged 45 and older, into the market requires massive logistical support. Guardant Health, Inc. has secured major agreements to leverage existing diagnostic infrastructure.
The collaboration with Quest Diagnostics is pivotal. Through a multi-year agreement announced in September 2025, Quest's provider clients can order Shield directly through their existing accounts, with availability expected in the first quarter of 2026. Quest's scale is significant: they provided healthcare connectivity solutions to approximately 650,000 clinician and hospital accounts last year. Furthermore, patients can access blood draws via Quest's 2,000 patient service centers and 6,000 in-office phlebotomists nationwide. At the time of this agreement, Quest Diagnostics held a market capitalization of $20.9 billion and reported a 12.6% revenue growth over the last twelve months on $10.5 billion in annual revenues.
Also supporting distribution, Guardant Health, Inc. announced a partnership with PathGroup in September 2025 to bring the Shield blood test to over 250+ hospitals and health systems across 25 states. This shows a clear strategy to embed the test within established regional and national lab ecosystems.
Biopharma Collaborations for Companion Diagnostics and Trials
For the advanced diagnostic and therapeutic selection side of the business, Guardant Health, Inc. partners with major pharmaceutical players to use their liquid biopsy technology in clinical settings. This validates the tests and drives Biopharma & Data revenue, which was reported at $54.7 million, an 18% increase in Q3 2025.
A notable agreement is the multi-year global collaboration with Pfizer, Inc., announced in April 2025. This partnership specifically aims to:
- Utilize Guardant Health, Inc.'s portfolio of liquid biopsy tests in Pfizer's global clinical studies.
- Evaluate circulating tumor DNA (ctDNA) level as a surrogate endpoint for monitoring therapy response.
- Provide Pfizer access to Guardant tests in China for their global clinical trials cohorts.
Guardant Health, Inc. also entered an exploratory collaboration with Taiho Pharmaceutical in September 2025. This leverages the GuardantINFORM™ platform to discover new biomarker signatures for early-stage recurrent cancer, focusing on minimal residual disease (MRD) testing cohorts.
AI/Data Analytics Firms for Enhanced Insights
The value proposition for biopharma partners is heavily reliant on data integration and predictive analytics. Guardant Health, Inc. is actively integrating its molecular data with leading AI platforms. As of October 2025, Guardant Health, Inc. had a market capitalization of about $9 billion.
The collaboration with ConcertAI, announced in January 2025, created a Data-As-A-Service offering integrating clinical and tumor profiling data. This joint RWD (real-world data) solution provides access to ConcertAI's national database of 5.5 million clinical records alongside Guardant profiling data across 60+ tumor types.
Also in October 2025, a strategic partnership was announced with Zephyr AI. This links Guardant's multimodal molecular data with Zephyr AI's analytics platform to develop novel cancer biomarkers and generate predictions of targeted cancer therapy responses. This integration is designed to work with Guardant's existing Infinity AI capabilities.
Public Health and Research Organizations
To address screening gaps and health equity, Guardant Health, Inc. engages with non-profit and governmental bodies. In Q3 2025, the company established a partnership with the American Cancer Society to specifically expand cancer screening access and advance health equity.
The involvement with the National Cancer Institute (NCI) is critical for validating the multi-cancer detection (MCD) technology. Guardant Health, Inc.'s Shield MCD test was selected for the NCI's Vanguard Study, a four-year pilot study aiming to enroll up to 24,000 participants to evaluate MCD tests in future randomized controlled trials. The Shield MCD test data, presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated an overall specificity of 98.6% and a cancer sensitivity of 75% across 10 cancer types, with per-cancer sensitivity ranging from 62% to 96%.
Here's a quick look at the scale of these key relationships as of late 2025:
| Partner Type | Partner Example | Key Metric / Scale | Relevance to Guardant Health, Inc. |
|---|---|---|---|
| Diagnostic Lab Network | Quest Diagnostics | Access to 650,000 clinician/hospital accounts; 2,000 PSCs. | Accelerated, nationwide access for Shield CRC screening, available Q1 2026. |
| AI/Data Analytics | ConcertAI | Integration with 5.5 million clinical records across 60+ tumor types. | Creates multi-modal RWD for biopharma to accelerate therapy R&D. |
| Biopharma | Pfizer, Inc. | Multi-year global collaboration utilizing Guardant Infinity platform. | Supports development/commercialization of Pfizer's oncology portfolio; includes China access. |
| Public Health/Research | National Cancer Institute (NCI) | Shield MCD selected for Vanguard Study; aims to enroll up to 24,000 participants over 4 years. | Critical validation for MCD technology in large-scale clinical trial design. |
The overall financial impact is seen in the full-year 2025 revenue guidance, which Guardant Health, Inc. increased to a range of $965 to $970 million, representing approximately 31% growth compared to 2024. The screening revenue component specifically grew to $24.1 million in Q3 2025 from just $1.0 million in the prior year period, largely due to Shield adoption.
Guardant Health, Inc. (GH) - Canvas Business Model: Key Activities
You're looking at the core engine driving Guardant Health, Inc.'s growth as of late 2025. The key activities revolve around the continuous development, validation, and aggressive commercial rollout of their liquid biopsy portfolio, heavily supported by their proprietary technology platform.
Developing and Commercializing Liquid Biopsy Tests (Guardant360, Shield, Reveal)
The commercialization efforts are segmented, with Oncology being the largest driver, but Screening is accelerating rapidly. In the third quarter of 2025, Guardant Health, Inc. reported significant volume increases across the board.
Oncology test volume, which includes Guardant360 Liquid, Guardant360 Tissue, and Reveal, grew 40% year-over-year in Q3 2025, reaching approximately 74,000 tests performed. This segment generated $184.4 million in revenue for the quarter. Guardant360 Liquid, specifically, achieved its fifth consecutive quarter of accelerating growth, with volumes up more than 30%. For the full year 2025, Oncology revenue is now expected to grow approximately 25% year-over-year.
The Shield test, for early detection, is scaling quickly. In Q3 2025, Screening revenue was $24.11 million, generated from approximately 24,000 Shield tests. Management noted that screening has started generating meaningful revenue tracking at an annual run rate of approximately $100 million roughly one year into the commercial launch of the FDA-approved product. Furthermore, Guardant Health, Inc. received new Guardant360 companion diagnostic approvals for breast cancer and non-small cell lung cancer in Q3 2025.
| Product/Segment | Q3 2025 Volume (Tests) | Q3 2025 Revenue (USD) | Key Metric/Status |
|---|---|---|---|
| Oncology (Total) | ~74,000 | $184.4 million | Volume up 40% year-over-year |
| Screening (Shield) | ~24,000 | $24.1 million | Annual run rate tracking at ~$100 million |
| Biopharma & Data | N/A | $54.73 million | Revenue up 18% year-over-year |
Conducting Extensive Clinical Studies and Generating Real-World Data for Regulatory Submissions
A critical activity is generating the data needed to secure regulatory clearances and expand reimbursement, which directly impacts commercial adoption. Guardant Health, Inc. expanded Shield to include multi-cancer detection (MCD) and initiated a large-scale real-world data initiative for Shield MCD, which showed strong performance utilizing the InfinityAI learning engine.
Key regulatory milestones in late 2025 include:
- Reached a major milestone with the submission of the Guardant360 Liquid PMA application to the FDA.
- Submitted Reveal immuno-oncology monitoring data package to MolDx for Medicare reimbursement.
- Presented data across multiple major conferences, including ASCO 2025, ESMO 2025, and SABCS 2025, showcasing utility in areas like MRD detection and therapy selection.
- Data presented at ASCO GI 2025 supported the cost-effectiveness of blood-based colorectal cancer screening.
Scaling the Commercial Sales and Marketing Infrastructure for the Shield Launch
The company is actively investing to support the growth of its portfolio, especially Shield. Total non-GAAP operating expenses for Q3 2025 were $270.6 million, rising primarily due to the expansion of the commercial team and marketing efforts for the Shield product launch. This investment is strategic; management indicated in Q2 that they were accelerating the build-out of commercial infrastructure and expected to surpass 250 sales reps by the end of 2025. The overall 2025 revenue guidance was raised to a range of $965 to $970 million, representing 31% year-over-year growth.
Advancing Proprietary Smart Liquid Biopsy (SLB) and Infinity AI Technology
The technological backbone is the Guardant Infinity platform, which is described as the first and only platform combining genomic, epigenomic, and RNA-based profiling to deliver multiomic insights. The proprietary methylation technology within Infinity offers up to a 1300% increase in molecule recovery compared with bisulfite methods, boosting sensitivity for circulating tumor DNA (ctDNA) detection.
Development and application advancement included:
- Launching 11 new Smart Liquid Biopsy applications for Guardant360 Liquid in Q2 2025.
- Utilizing the InfinityAI learning engine to support Shield MCD data.
- Establishing a multi-year global collaboration with Pfizer to support development utilizing the Infinity smart liquid biopsy platform.
The non-GAAP gross margin for the company improved to 66% in Q3 2025, up from 63% the previous year, showing operational leverage is starting to take hold. Excluding screening, the rest of the business became cash flow positive one quarter earlier than expected. Finance: draft 13-week cash view by Friday.
Guardant Health, Inc. (GH) - Canvas Business Model: Key Resources
You're looking at the core assets that make Guardant Health, Inc. (GH) tick, the things they own or control that are essential to delivering their value proposition. These aren't just line items on a balance sheet; they are the engine for their growth in precision oncology and screening.
The foundation rests heavily on their proprietary liquid biopsy technology and intellectual property. This is the science that lets them detect cancer signals from a simple blood draw, which is a massive differentiator. While the exact patent count isn't public-facing data I can cite here, the company's entire valuation and product pipeline are built upon this protected technology base.
Next up is the extensive real-world genomic and clinical data repository, which they commercialize through GuardantINFORM. This database is built from their testing volume and integrates information from next-generation sequencing, demographics, diagnoses, treatment, and pharmacy prescription data across 60+ solid tumor cancer types. This longitudinal data is crucial for drug development partners and for refining their own algorithms. For instance, a study on the Shield test used an expanded cohort of 20,000 patients to confirm performance.
The commercial viability is cemented by their FDA-approved and NCCN-included products. The Shield blood test is the prime example here. It is the first and only blood test to receive full FDA approval as a primary screening option for colorectal cancer in average-risk adults aged 45 and older. The latest algorithm, Shield V2, shows a sensitivity of 84% for colorectal cancer and a specificity of 90%, with stage I sensitivity at 62%. Furthermore, the National Comprehensive Cancer Network (NCCN) updated its guidelines to include Shield as the first blood test approved for primary screening. For Medicare patients, the test secured Advanced Diagnostic Laboratory Test (ADLT) status, initiating an initial reimbursement rate of $1,495 for a nine-month period starting April 1, 2025.
To drive adoption of these key products, Guardant Health, Inc. is heavily investing in its commercial reach. The plan is to have a growing commercial sales force, expected to surpass 250 representatives by year-end 2025. This expansion is supported by the strong financial outlook, with full-year 2025 revenue guidance raised to the range of $965 to $970 million as of Q3 2025.
Here's a quick look at some of the scale and financial context surrounding these resources as of late 2025:
| Key Metric | Value / Status | Date/Period |
| Market Capitalization | $12.6B | As of November 7, 2025 |
| Total Assets (TTM) | $1,276,786 thousand | As of September 30, 2025 |
| Q3 2025 Total Revenue | $265.2 million | Quarter ended September 30, 2025 |
| Non-GAAP Gross Margin | 66% | Q3 2025 |
| Shield Test Adherence Rate | Over 90% | Reported |
| Data Repository Cancer Types | 60+ solid tumor types | GuardantINFORM |
The operational strength is also reflected in their growing test volumes, which is a direct measure of the utilization of their core technology. For example, oncology test volume grew 40% year-over-year in Q3 2025, reaching approximately 74,000 tests.
You should keep an eye on how they manage the ongoing investment in commercial infrastructure, as Q3 2025 non-GAAP operating expenses were guided to be in the range of $865 to $875 million for the full year, reflecting this build-out. Finance: draft 13-week cash view by Friday.
Guardant Health, Inc. (GH) - Canvas Business Model: Value Propositions
You're looking at the core reasons why oncologists, patients, and biopharma partners choose Guardant Health, Inc. over alternatives as of late 2025. It boils down to timing, convenience, and comprehensive data across the entire cancer journey.
Non-invasive, convenient blood test for early cancer screening (Shield)
The value here is moving cancer detection from invasive procedures to a simple blood draw. For colorectal cancer (CRC) screening in average-risk adults aged 45 and older, Shield is the first and only blood test to receive full FDA approval as a primary screening option. The adherence rate in a study of the first 20,000 patients reached 95%, significantly surpassing the 25-71% reported adherence for traditional stool-based tests. In specific low-screening areas like Appalachia, adding Shield increased overall CRC screening rates from 45% to 90%, with Shield itself showing an adherence rate of 98.5% in that setting. The latest algorithm, Shield V2, demonstrated a sensitivity of 84% for CRC detection with 90% specificity, including 62% sensitivity for stage I disease. When it received ADLT status from CMS in Q1 2025, the Medicare pricing was set at $1,495. The Screening segment generated $24.1 million in revenue in the third quarter of 2025, primarily from approximately 24,000 Shield tests.
Comprehensive genomic profiling for advanced cancer treatment selection (Guardant360)
For patients with advanced cancer, the value proposition is getting the most comprehensive actionable information quickly to select the right therapy. Guardant Health, Inc. is pushing the utility of its liquid biopsy tests, with Guardant360 Liquid volume showing accelerated year-over-year growth for the fourth consecutive quarter as of Q2 2025. In Q2 2025, the company's Oncology segment, driven by Guardant360 and Reveal, processed approximately 64,000 tests, a 30% increase in volume year-over-year, contributing $158.7 million in revenue. The average selling price (ASP) for the Guardant360 Tissue test improved to approximately $2,000 in Q2 2025, hitting a 2028 target three years early. For Guardant360 Liquid, the ASP in Q1 2025 was reported in the range of $3,000 to $3,100. The clinical utility is enhanced by the introduction of 11 new Smart Liquid Biopsy applications in Q2 2025.
Minimal Residual Disease (MRD) monitoring for recurrence in early-stage cancer (Reveal)
Reveal offers the ability to detect recurrence earlier than imaging, providing clarity for adjuvant therapy decisions. This tissue-free test tracks changes in circulating tumor DNA (ctDNA) using epigenomic signals. In one study, Guardant Reveal was shown to predict long-term patient benefit up to 18 months earlier than standard clinical measures. For Medicare reimbursement in CRC, Guardant Reveal is covered to guide adjuvant therapy decisions and for longitudinal recurrence surveillance every 3 to 6 months. The company announced that Reveal became gross margin positive in the first quarter of 2025. The expanded offering for late-stage therapy response monitoring can provide actionable insights in just seven days.
Accelerating biopharma drug development via real-world data and AI-driven insights
The value for biopharma partners is access to a growing, high-quality dataset that informs drug development and commercial strategy. The Biopharma & Data segment generated $56.0 million in revenue in Q2 2025, marking a 28% increase year-over-year, and then $54.7 million in Q3 2025, an 18% increase year-over-year. The full-year 2025 revenue guidance for Biopharma and Data was raised to the mid-teens percentage growth in Q2. The company ended Q3 2025 with $689.5 million in cash, cash equivalents, and restricted cash.
Here's a quick look at the segment performance driving this value:
- Total 2025 Revenue Guidance (as of Q3): $965 to $970 million
- Q3 2025 Oncology Test Volume Growth YoY: 40%
- Q2 2025 Non-GAAP Gross Margin: 66%
- Expected Full Year 2025 Free Cash Flow Burn: $225 to $235 million
Guardant Health, Inc. (GH) - Canvas Business Model: Customer Relationships
You're looking at how Guardant Health, Inc. (GH) manages its relationships with the key groups it serves. It's a multi-pronged approach, balancing deep clinical support with broad data partnerships.
Dedicated, high-touch sales and clinical support for oncologists and health systems.
Guardant Health, Inc. (GH) is scaling its commercial team to support this high-touch model. The company plans for a steady-state sales force of approximately 700 reps. For 2025, an accelerated deployment target was set for around 200 fully trained reps by the end of the year. This field presence is supported by clinical oncology specialists providing molecular information support. Investment in this area is reflected in the operating expenses; Non-GAAP operating expenses for the third quarter of 2025 reached $228.9 million, up from $187.3 million in the third quarter of 2024, due in part to commercial team expansion. Full-year 2025 non-GAAP operating expense guidance is set in the range of $865 to $875 million. The core Oncology business generated $184.4 million in revenue in Q3 2025, driven by approximately 74,000 oncology tests for the quarter. This segment is expected to see approximately 25% growth in volume for the full year 2025. It's clear they are putting significant resources behind direct engagement with clinicians.
Strategic, long-term collaboration model with biopharma partners for data and co-development.
The Biopharma & Data segment is a key relationship area, focusing on providing real-world clinicogenomic data to accelerate drug development. This segment's revenue growth has been strong:
| Metric | Q1 2025 Revenue ($M) | Q2 2025 Revenue ($M) | Q3 2025 Revenue ($M) |
| Biopharma & Data Revenue | 45.4 | 56.0 | 54.73 |
| Year-over-Year Growth | 21% | 28% | 18% |
Guardant Health, Inc. (GH) has established significant collaborations, including a multi-year global collaboration with Pfizer for the Infinity platform and a partnership with COTA to combine clinicogenomic data with real-world EHR data. Furthermore, a strategic partnership with Boehringer Ingelheim is in place for Zongertinib companion diagnostics.
Educational and awareness campaigns targeting primary care physicians and consumers.
Awareness and adoption campaigns are heavily focused on the Shield screening platform. Shield screening revenue saw massive growth, moving from $1.00 million in Q3 2024 to $24.11 million in Q3 2025, representing a year-over-year growth of over 1000%. Shield test volume reached approximately 16,000 tests in Q2 2025 and is projected to generate between $71 and $73 million in revenue for the full year 2025. To expand access and awareness, Guardant Health, Inc. (GH) established a partnership with the American Cancer Society to advance health equity. The company also expanded Shield to include multi-cancer detection (MCD).
Seamless integration of ordering and results into Electronic Medical Records (EMR).
Guardant Health, Inc. (GH) focuses on digital solutions to optimize clinical workflows. The company states it collaborates closely with several major EMR platforms. This collaboration is designed to provide tangible benefits to providers by enabling convenient access to test ordering and results directly within the patient chart. The goal is to simplify and standardize test ordering with EMR-integrated tools designed for speed and consistency. The company receives all customer requests for potential integrations and will create customized solutions for other EMR systems.
- Integrate Guardant Health, Inc. (GH) data directly into the patient chart.
- Support timely, guideline-based testing through automated workflows built into the EMR.
- Simplify and standardize test ordering with EMR-integrated tools.
Finance: review Q3 2025 commercial spend vs. sales force deployment targets by end of next week.
Guardant Health, Inc. (GH) - Canvas Business Model: Channels
Direct sales force targeting oncologists, hospitals, and health systems deployment plan for late 2025 included reaching approximately 200 fully trained reps by the end of 2025, with a steady-state target of approximately 700 reps.
Third-party laboratory and distribution partners are utilized for broader access, evidenced by strategic collaborations established with Quest Diagnostics and PathGroup to further accelerate nationwide access to Shield.
Direct-to-biopharma/pharmaceutical companies for data and development services generated the following revenue figures in 2025:
- Q3 2025 Biopharma & Data revenue: $54.7 million.
- Q3 2025 Biopharma & Data year-over-year growth: 18%.
- Q2 2025 Biopharma & Data revenue: $56.0 million.
- Q2 2025 Biopharma & Data year-over-year growth: 28%.
- Q1 2025 Biopharma & Data revenue: $45.4 million.
- Q1 2025 Biopharma & Data year-over-year growth: 21%.
- Full year 2025 expected Biopharma & Data revenue growth: mid-teens range.
Centralized CLIA-certified and CAP-accredited testing laboratories processed the following volumes in 2025:
| Metric | Q3 2025 | Q2 2025 | Q1 2025 |
| Oncology Tests Performed | Approximately 74,000 | Approximately 64,000 | Approximately 59,000 |
| Oncology Test Volume Y/Y Growth | 40% | 30% | 25% |
| Shield Tests Performed | Approximately 24,000 | Approximately 16,000 | Not specified (Revenue: $5.7 million) |
The potential annual sample processing capacity, based on Shield adoption assumptions, is estimated at more than 16 million samples annually.
Revenue generated through the Screening channel (Shield) in 2025 included:
- Q3 2025 Screening revenue: $24.1 million.
- Q2 2025 Screening revenue: $14.8 million.
- Full year 2025 expected Screening revenue range: $71 million to $73 million.
Guardant Health, Inc. (GH) - Canvas Business Model: Customer Segments
You're looking at the core groups driving Guardant Health, Inc.'s growth as of late 2025, based on their latest reported financials. The business model clearly targets distinct needs across the cancer care continuum, from diagnosis to treatment selection and early detection.
Oncologists and hospitals treating patients with advanced-stage cancer.
This group drives the core Oncology segment, relying on tests like Guardant360 Liquid, Guardant360 Tissue, and Reveal for therapy selection and recurrence monitoring. The momentum here is strong; in the third quarter of 2025, this segment generated $184.4 million in revenue, which is a 31% year-over-year increase. Test volume was approximately 74,000 tests, marking a 40% year-over-year jump. Management is guiding for the full-year 2025 Oncology revenue to grow by roughly 25%. The Reveal test, specifically, is noted as the fastest-growing oncology product.
Here's a look at the recent performance metrics for the Oncology customer base:
| Metric (Q3 2025) | Value | Year-over-Year Change |
| Oncology Revenue | $184.4 million | 31% increase |
| Oncology Test Volume | Approx. 74,000 tests | 40% increase |
| Guardant360 Liquid Volume Growth | N/A | Fifth consecutive quarter of accelerating growth (more than 30% YoY) |
Biopharmaceutical companies seeking genomic data and companion diagnostic development.
This segment, reported as Biopharma & Data, is crucial for driving research and development partnerships. In the third quarter of 2025, this revenue stream brought in $54.7 million, an 18% year-over-year increase. This growth included milestone revenue from two companion diagnostic (CDx) approvals. A key example of this customer relationship is the multi-year global collaboration announced in April 2025 with Pfizer, Inc. (NYSE: PFE), utilizing the Guardant Infinity smart liquid biopsy platform. Full-year 2025 guidance suggests this revenue will continue to grow in the mid-teens range.
Primary care and OBGYN physicians for colorectal cancer screening.
Physicians ordering the Shield test for routine colorectal cancer screening form the Screening segment. This segment is seeing explosive growth. In Q3 2025, Shield revenue reached $24.1 million from approximately 24,000 tests. This puts the annualized run rate for Screening revenue at roughly $100 million, only about one year into the commercial launch of the FDA-approved Shield test. The Average Selling Price (ASP) for Shield in Q3 2025 was approximately $880. Furthermore, due to Accelerated Approval Pathway (ADLT) status, the Medicare price for Shield increased from $920 to $1,495 effective April 1, 2025.
The full-year 2025 revenue guidance for Screening was significantly raised to the range of $71 million to $73 million, expecting volumes between 80,000 to 82,000 tests.
Patients eligible for routine cancer screening who prefer a non-invasive option.
These are the end-users for the Shield test, representing a massive addressable market. The sequential adoption shows clear traction among this group, with volumes growing from 9,000 tests in Q1 2025 to 16,000 tests in Q2 2025. The Shield test is being made more accessible through strategic alliances with major labs like Quest Diagnostics and PathGroup. Additionally, access was expanded to individuals age 45 and older through the VA Community Care Network, covering over 9 million beneficiaries.
The Shield Multi-Cancer Detection (MCD) capabilities, which showed 60% overall sensitivity and 89% accuracy for cancer site of origin in validation data, broadens the appeal beyond just colorectal cancer screening.
You should track the Shield adoption numbers closely; they are a key driver for the raised full-year 2025 total revenue guidance to $965 million to $970 million.
Guardant Health, Inc. (GH) - Canvas Business Model: Cost Structure
You're looking at the spending profile for Guardant Health, Inc. (GH) as they push for scale, especially with the Shield test. The cost structure is heavily weighted toward getting the commercial engine running and continuing to build out the pipeline. Honestly, it's a classic growth-stage investment pattern where operating expenses are high relative to current revenue, but the goal is to drive future volume and margin expansion.
The company has been consistently raising its full-year spending outlook to fund this growth. For the full-year 2025, Guardant Health, Inc. (GH) is guiding total non-GAAP operating expenses to be in the range of $865 million to $875 million. This reflects a deliberate step-up from earlier guidance, which was $840 million to $850 million as of Q2 2025, and $815 million to $825 million at the start of the year. This increase is directly tied to the commercial ramp for Shield.
When you break down those operating costs, research and development (R&D) remains a significant fixed investment area for the new product pipeline. For the twelve months ending September 30, 2025, Guardant Health, Inc. (GH)'s research and development expenses totaled $0.359B. To give you a sense of the quarterly spend, the Sales and Marketing expense for the second quarter of 2025 was $119,588 thousand, and the R&D expense for that same quarter was $87,449 thousand.
On the flip side of the cost equation, the Cost of Goods Sold (COGS) related to testing is showing improvement, which is key to long-term profitability. The company has guided the full-year 2025 non-GAAP gross margin to be in the range of 64% to 65%. This is an improvement from the 62% to 63% range guided earlier in the year. For context, the non-GAAP gross margin achieved in the third quarter of 2025 was 66%, up from 63% in the prior year period. This margin expansion is helped by operational efficiencies, such as the 50% reduction in COGS achieved for the Reveal test in 2024, and favorable pricing for Shield, which saw its Medicare rate rise to $1,495 starting April 1, 2025, due to its Advanced Diagnostic Laboratory Test (ADLT) status.
Here's a quick look at the most recently reported quarterly operating expense breakdown from Q3 2025, which shows where that investment is going:
| Expense Category (Non-GAAP) | Q3 2025 Amount (in millions) | Year-over-Year Change |
|---|---|---|
| Non-GAAP Operating Expenses Total | $228.9 million | Increased 22% |
| Sales and Marketing (Implied from GAAP OpEx context) | Significant driver of OpEx increase | Driven by Shield commercial team expansion |
| Research and Development (TTM ending Sep 30, 2025) | $359 million | Increased 4.48% YoY |
The high investment in commercial infrastructure and marketing for Shield's launch is evident in the operating expense structure. The company is prioritizing market penetration now, which means absorbing higher costs in the near term to secure future revenue streams. The key cost drivers you need to watch are:
- High spending on commercial team expansion for Shield.
- Marketing activities supporting the Shield product launch.
- Ongoing Research and Development for the product pipeline.
- Cost of Revenue for testing, though improving with scale.
Finance: draft 13-week cash view by Friday.
Guardant Health, Inc. (GH) - Canvas Business Model: Revenue Streams
You're looking at the core ways Guardant Health, Inc. brings in money as of late 2025. It's a mix of established diagnostic services and a rapidly scaling early detection product. Honestly, the momentum in Q3 2025 suggests they are hitting their stride on the guidance they just raised.
The primary driver remains the Oncology test revenue, which includes flagship products like Guardant360 and Reveal. Management now expects this segment to grow approximately 25% year over year for the full 2025 fiscal year, up from prior expectations. This acceleration is supported by strong volume, with oncology test volume accelerating to greater than 30% growth in 2025 compared to 20% growth in 2024. To be fair, the third quarter saw a 31% year-over-year increase in Oncology revenue, hitting $184.4 million on approximately 74,000 tests.
Next up is the Screening test revenue from Shield. This is the growth story of the year, with guidance for the full year 2025 now set between $71 million to $73 million. That's a significant jump, reflecting strong adoption; in Q3 2025 alone, Shield brought in $24.1 million from about 24,000 tests. If onboarding takes 14+ days, churn risk rises, but the volume numbers suggest they are managing the process well enough to hit these targets.
The third stream is Biopharma and Data revenue, which comes from partnerships and data licensing activities. This segment is expected to see continued growth in the mid-teens range. In the third quarter of 2025, this revenue component was $54.7 million, marking an 18% year-over-year increase.
Here's the quick math on how these streams combine for the full-year outlook:
| Revenue Stream Component | Full-Year 2025 Guidance/Projection | Q3 2025 Actual Revenue ($M) |
| Oncology Test Revenue (Guardant360, Reveal) | Expected growth ~25% Y/Y | $184.4 |
| Screening Test Revenue (Shield) | $71 million to $73 million | $24.11 |
| Biopharma and Data Revenue | Expected growth mid-teens | $54.73 |
| Total Full-Year 2025 Revenue Guidance | $965 million to $970 million | $265.2 (Total Q3 2025) |
You can see the breakdown of the key revenue-generating activities that feed these streams:
- Guardant360 Liquid, Tissue, and Reveal volumes are accelerating.
- Oncology test volume growth was 40% year-over-year in Q3 2025.
- Shield volume reached approximately 24,000 tests in Q3 2025.
- Two additional companion diagnostic approvals were secured in Q3.
The overall confidence in these streams led Guardant Health, Inc. to raise its total full-year 2025 revenue guidance to a range of $965 million to $970 million, representing approximately 31% year-over-year growth. Finance: draft 13-week cash view by Friday.
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