Guardant360 CDx

The comprehensive tumor mutation profiling test for guiding treatment decisions


Guardant360® is a next-generation sequencing (NGS) liquid biopsy test that analyzes circulating tumor DNA (ctDNA) from blood samples. The test provides guideline-recommended genomic results to oncologists in just 7 days from sample receipt at the laboratory, for timely assigning targeted therapy to patients with advanced solid tumors.


Guardant360® detects somatic variants in a targeted panel of 74 genes (Guardant360® CDx) or 739 genes (Guardant360®) and high microsatellite instability (MSI-High). The Guardant360® CDx test is approved by FDA as a companion diagnostic for non-small cell lung cancer (NSCLC) treatments – TAGRISSO® (osimertinib), RYBREVANTTM(amivantamabvmjw), and LUMAKRASTM(sotorasib).


Contact us for any enquiries
Guardant Reveal Box

Liquid biopsy is a quick and feasible alternative to traditional tissue biopsy


With liquid biopsies, you can avoid the complications and delays of invasive tissue biopsies. The quick turnaround time of liquid biopsy test results which is approximately seven days upon sample receipt in the laboratory makes quick and accurate treatment decisions a reality. Comprehensive liquid biopsies are a feasible alternative to pick up actionable tumor mutations missed during tissue biopsies.

Key Features for Guardant360® CDX

FDA approved

First FDA-approved comprehensive liquid biopsy.1,2

7 DAYS TAT

Actionable results in 7 days.1,2†

<10 DAYS

Only requires 2 tubes of blood.3

Alterations covered

Guardant360 covers alterations in over 70 genes relevant to multiple solid tumors including MSI-High.

alterations covered

Key Features for Guardant360®

739 GENES

with variants detected at as low as 0.001% MAF.2

TUMOR FRACTION

based on methylation to accurately quantify disease burden.2-4

<10 DAYS

turnaround time for fast treatment decisions.2*

Alterations covered

Guardant360 covers alterations in over 70 genes relevant to multiple solid tumors including MSI-High.

alterations covered
+ Sample requirement

Two 10ml streck tubes.

+ Who and when to get tested

Patients with advanced solid-tumor cancers before first-line therapy or at progression.

+ Storage and shipping conditions

Ship same or next day at room temperature. Do not freeze or refrigerate.

Remark: When no biomarker is identified with Guardant360®, Guardant360 TissueNextTM is an alternative assessment when initially requested by the ordering provider.

Enabled more complete biomarker assessment than standard-of-care tissue testing

alterations covered

Guardant360® CDx liquid biopsy result available for 95% of patients for the 4 biomarkers with FDA-approves therapies vs 31% with tissue.1

Reference:
  1. Leighl NB et al. Clinical Utility of Comprehensive Cell-Free DNA Analysis to Identify Genomic Biomarkers in Patients with Newly Diagnosed Metastatic Non-Small Cell Lung Cancer, Clin Cancer Res. 2019

The process

1

Place an order with Guardant Health's designated local partner - Codex Genetics.

2

Provide blood samples of patients.

3

Samples will be sent to Guardant Health laboratary in the United States.

4

Complete genomic result in 7 days upon sample receipt in the US laboratory.

For any enquiry, please contact us.

Download Resources

Guardant360 Patient Brochure Guardant360 Specification Sheet
Are the tests available in Hong Kong?

Guardant Health precision oncology products – Guardant RevealTM, Guardant360® CDx, Guardant360 TissueNextTM are available in Hong Kong through the designated local partner, Codex Genetics.

Where will the tests perform?

The retrieved liquid or tumor biopsy will be performed at Guardant Health laboratory in California, the United States.

As a patient, can I order the tests by myself?

Patients are encouraged to discuss genetic testing options with their healthcare provider. For questions about how to access the tests, please feel free to contact us.

When will the report be ready?

Sample shipment will be arranged on the same or the next day upon sample retrieval. Upon sample received in Guardant Health laboratory in the US, the test report will be ready in around 7 days.

Guardant Health

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum.

Codex Genetics

About Codex Genetics

Codex Genetics enables precision medicine through AI-powered analytics on both genetic and clinical data. We aim to provide holistic, clinically actionable disease management solutions for medical professionals and individuals. We provide services to accelerate diagnostic processes and help disease treatment and disease management.