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FDA-approved companion diagnostic

Guardant360 CDx

FDA-approved liquid biopsy NGS assay that profiles ctDNA from plasma to detect genomic alterations in solid tumors and support selection of targeted therapies.

Lab-developed CDxMethod: NGSSpecimen: PlasmaBiomarker: 74 genes
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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
P200010
Supplements
S001, S002, S008, S010
Manufacturer
Guardant Health, Inc.
Approval date
August 7, 2020
Test specifications
Methodology
NGS
Specimen
Plasma
Report format
Comprehensive report PDF
Turnaround (typical)
5 Days
Biomarker(s)
What this test is

Guardant360 CDx is an FDA-approved, single-site next-generation sequencing assay that analyzes circulating tumor DNA from peripheral blood to detect substitutions, indels, copy number changes, and select fusions across a broad panel of cancer-related genes. As a plasma-based companion diagnostic, it provides a comprehensive genomic profile of solid tumors to help identify patients who may be candidates for targeted treatment strategies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Breast CancerESR1ESR1 missense mutations between codons 310 and 547ORSERDU
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 forGuardant360 CDx directly from your existing workflow.

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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