Guardant360
Overview
Guardant360 is a clinically validated liquid biopsy test developed by Guardant Health, a leader in precision oncology. It leverages advanced AI-enhanced genomic and epigenomic insights derived from a simple blood sample to provide comprehensive tumor mutation profiling. This innovative diagnostic tool assists oncologists in making informed therapy decisions, identifying suitable clinical trials, and monitoring tumor evolution for patients with advanced solid malignant cancers. By analyzing circulating tumor DNA (ctDNA), Guardant360 offers a non-invasive alternative to traditional tissue biopsies, providing rapid and actionable genomic results to personalize cancer care across various solid tumor types, including lung, breast, colorectal, and prostate cancers. The test is designed to overcome the challenges of tissue biopsy, allowing for faster and easier comprehensive genomic profiling.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Clinically validated comprehensive liquid biopsy for advanced solid tumors
- AI-enhanced genomic and epigenomic insights from cell-free DNA (cfDNA)
- Detects single nucleotide variants, copy number amplifications, fusions/rearrangements, and indels across a panel of 73-74 genes (Guardant360 CDx) or 739 genes (Guardant360)
- FDA-approved as a companion diagnostic for specific targeted therapies
- Provides rapid turnaround time for results (approximately 7 days from sample receipt)
- Offers molecular subtyping (e.g., breast, lung) and pharmacogenomic insights
- Facilitates identification of patient-specific treatment recommendations and clinical trial eligibility
- Accessible via a HIPAA-secure online provider portal and iPhone app for result access and clinical support
- Supported by mobile phlebotomy services for convenient sample collection
- Integrates with EMR systems for streamlined ordering and result management
Use Cases
- Guiding therapy decisions for oncologists in advanced solid tumors
- Identifying clinical trials for cancer patients
- Assessing response to cancer treatment and monitoring tumor evolution
- Comprehensive genomic profiling for solid malignant neoplasms
- Molecular breast and lung subtyping for refined diagnosis
- Pharmacogenomics to optimize treatment and reduce toxicity
What Physicians Need to Know
Guardant360 offers comprehensive genomic profiling from a simple blood draw, with results typically available in 7 days, enabling timely, personalized treatment decisions for patients with advanced solid tumors. It is particularly valuable when tissue biopsy is challenging, insufficient, or inconclusive, or for monitoring treatment response and detecting molecular changes earlier than traditional imaging. Guardant360 CDx is FDA-approved as a companion diagnostic for several targeted therapies across various cancer types. Utilize the Guardant Portal and client services for streamlined access to results and support.
Guardant Health provides robust integration capabilities with major Electronic Medical Record (EMR) platforms, including Epic. These integrations streamline workflows by enabling direct test ordering and automated delivery of results into the patient chart. They also offer digital solutions for patient cohort analysis and support guideline-complete testing pathways, with customizable options for various EMR systems.
Details
| Category | Drug Discovery & Research, Lab & Diagnostics, Oncology AI |
| Pricing |
Contact for pricing
|
| Deployment | Lab-based service (blood samples sent to Guardant Health's CLIA-certified and CAP-accredited laboratory) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling in patients with any solid malignant cancer. It is also approved as a companion diagnostic for specific targeted therapies in non-small cell lung cancer, breast cancer, and colorectal cancer. |
| Integrations | |
| EHR | Not specified |
| Specialties | Laboratory Medicine, Oncology, Pathology |
What the Web Says
Guardant360 is a liquid biopsy test that helps guide treatment decisions for patients with advanced solid-tumor cancers by identifying genomic alterations from a blood sample. It offers a less invasive alternative to traditional tissue biopsies and provides results typically within seven days. Many physicians and patients report that the test has been instrumental in identifying targeted therapies and informing treatment plans, potentially prolonging life and improving quality of life.
Overall: PositiveStrengths
- Less invasive than traditional tissue biopsies, requiring only a blood draw.
- Faster turnaround time for results (around 7 days), enabling quicker treatment decisions.
- Helps identify specific genomic alterations and actionable biomarkers, guiding targeted therapy options.
- Can be used when tissue biopsy is not feasible due to health risks, tumor location, or insufficient material.
- Covered by insurance in many cases, and Guardant Health offers co-pay assistance programs.
- Useful for monitoring treatment response and detecting recurrence.
Limitations
- Some oncologists may be skeptical of its reliability or prefer tissue biopsies.
- May not detect all existing mutations, and results can sometimes differ from tissue biopsies or other liquid biopsy tests like Tempus.
- A single test might not definitively determine if a mutation is from a tumor, especially with low cfDNA percentages; subsequent tests may be needed for confirmation.
- Can be expensive if not covered by insurance, with out-of-pocket costs potentially reaching thousands of dollars.
- Some employee reviews of Guardant Health (the company) mention a toxic work culture and issues with compensation.
- Not intended to be used as the sole means for clinical diagnosis or patient management decisions.
Based on reviews from: Reddit, YouTube, DOH Health Technology Review, Clinicsoncall.com, Inspire, PMC, Comparably
Last updated: 2026-07-22
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Frequently Asked Questions
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Funded through the company that built this tool.
