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FDA-approved companion diagnostic

Guardant360® Liquid CDx

A comprehensive genomic profiling assay used as a companion diagnostic to select patients for targeted therapies across multiple solid tumors.

Lab-developed CDxMethod: NGSSpecimen: Whole bloodBiomarker: 741 genes
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Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P250027
Supplements
Manufacturer
Guardant Health, Inc.
Approval date
May 19, 2026
Test specifications
Methodology
NGS
Specimen
Whole blood
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
What this test is

Guardant360® Liquid CDx is an in vitro diagnostic test that uses next-generation sequencing to identify genomic alterations in solid tumors. It is approved by the FDA as a companion diagnostic for multiple targeted therapies across tumor types.

Results from this assay help determine whether a patient is eligible for specific therapies based on the genomic profile of their tumor.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Breast CancerESR1ESR1 E380, V422del, S463, L469, L536, Y537, and D538 mutationsINLURIYO
ESR1 missense mutations between codons 310 and 547ORSERDU
Colorectal Cancer (CRC)BRAFV600EBRAFTOVI + ERBITUX
Non-Small Cell Lung Cancer (NSCLC)EGFR (HER1)Exon 19 deletions or exon 21 L858R, and T790MTAGRISSO
Exon 20 insertionsRYBREVANT
ERBB2 (HER2)Activating Mutations (SNVs And Exon 20 Insertions)ENHERTU
KRASG12CLUMAKRAS

Performing lab

Guardant Health, Inc.

Penobscot Drive Lab (05D2070300)

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Order this test

If your organization is connected to Casandra, you can place an electronic order for Guardant360® Liquid CDx directly from your existing workflow.

Order via Casandra

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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