Guardant360®
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Searching for
guideline-recommended
genomic information?

Get results fast.

Guide treatment decisions in 7 days*
with Liquid Biopsy.

*Upon sample receipt in the laboratory

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The Guardant360® test is Guardant Health’s comprehensive liquid biopsy test which helps guide treatment decisions for patients with advanced stage cancer. The Guardant360® assay provides fast, accurate and comprehensive genomic results from a simple blood draw in approximately seven days upon receipt in the laboratory. This test can be used by physicians for tumor mutation profiling in patients across all solid cancers and provides doctors with guideline-recommended genomic results to make informed treatment decisions.

A blood test does not require tissue testing, enabling more patients to benefit from the growing number of FDA-approved targeted therapies. It is a leading next generation sequencing test that analyzes circulating tumor DNA (ctDNA). ctDNA is produced when tumors shed small pieces of their genetic material into the bloodstream. Traces of this ctDNA can be detected in the blood using digital sequencing technology.

Guardant360_KV_update

First US FDA approved liquid biopsy

Since it was first introduced, the Guardant360 liquid biopsy test has become widely accepted for blood-based comprehensive genomic profiling (CGP) with more than 300 peer-reviewed publications. It has been trusted by more than 12,000 oncologists with more than 300,000 tests performed to date. In August 2020, the Guardant360® CDx test became the first US FDA-approved liquid biopsy for comprehensive tumor mutation profiling across all solid cancers.

This US FDA approval validates the technology behind the Guardant360® assay that we offer to patients with advanced stage cancer. The Guardant360® CDx test has also been approved by the US FDA as a companion diagnostic to identify patients with non-small cell lung cancer who may benefit from treatment with TAGRISSO® (osimertinib), RYBREVANT™ (amivantamab-vmjw), LUMAKRAS™ (sotorasib) and ENHERTU® (amivantamab-vmjw).

Treatment Selection: For patients with advanced cancer

Targeted cancer therapies provide better patient outcomes and fewer side effects than broad-based chemotherapy. But an individual’s response to a given treatment often depends on the tumor’s genomic profile. Guardant360® detects all four classes of genomic variations in 74 genes most relevant to multiple solid tumors including microsatellite instability-high (MSI-high).

If you are a healthcare provider looking for information about Guardant360®, please visit our product website.  If you are located in Asia, Middle East or Africa and would like to request a Guardant360® kit for your patient, click here.

Clinical Experience of using the Guardant360® Test Video

Hear from Prof. Nir Peled, a leading medical oncologist from Israel, as he shares his clinical experience of using the Guardant360® liquid biopsy test.

High Concordance with Tissue1

concordanse

for targetable alterations*
before first-line therapy (n=81)
*EGFR, ALK, MET, BRCA1, ROS1, RET, ERBB2, or BRAF

High Concordance with Tissue1

concordanse

for targetable alterations*
before first-line therapy (n=81)
*EGFR, ALK, MET, BRCA1, ROS1, RET, ERBB2, or BRAF

Tissue has limitations beyond your control

Tissue has limitations beyond your control

Treatment delays


Results may be unpredictable
and incomplete

Patient burden


Repeated tissue biopsies
may expose patients to
potential adverse events

Finite resource


Tissue exhausted by histopathology stains and PD-L1 testing

Practice/staff burden


Coordination involving
multiple care team members

Relying solely on tissue leads to undergenotyping

~1 in 2 NSCLC patients are unable to get complete genomic results from tissue1

EGFR
ALK
ROSI
BRAF
MET
RET
ERBB2 (HER2)
NTRK

When to use Guardant360®

When to use Guardant360®

Before 1st Line Treatment

Get ahead of the challenges of tissue testing in
advanced NSCLC by utilizing Guardant360 to guide 1L
treatment decisions

At Disease Progression

Get genomic information on over 70+ genes relevant across
multiple solid tumors including MSI-High to help find pan cancer
therapies and clinical trials.

Published Data

Prospective study of 323 NSCLC patients found
Guardant360 improved alteration detection1

Published Data

Prospective study of 323 NSCLC patients found
Guardant360 improved alteration detection1

44_patients_agree_tissue_testing

were unable to get genomic results
from tissue biopsy

1.7x_as_many_patients

had targetable alterations* detected
by Guardant360® and tissue testing (n=82) versus tissue testing alone (n=47)
*EGFR, ALK, MET, BRCA1, ROS1, RET, ERBB2, or BRAF.

853.7_percentage

had an objective tumor response or stable disease based on RECIST

44_patients_agree_tissue_testing

were unable to get genomic results
from tissue biopsy

1.7x_as_many_patients

had targetable alterations* detected
by Guardant360® and tissue testing (n=82) versus tissue testing alone (n=47)
*EGFR, ALK, MET, BRCA1, ROS1, RET, ERBB2, or BRAF.

853.7_percentage

had an objective tumor response or stable disease based on RECIST

NSCLC comprehensive results in 7 days from sample receipt at the laboratory

Test

with Guardant360® when patient is diagnosed with advanced NSCLC

Get results in 7 days

from sample receipt
at the laboratory to guide treatment decisions

Take action

with first-line
treatment

Guardant 360 image
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Clinical Samples Reported
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Biopharma Partners
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Ordering Oncologists
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Peer-reviewed publications

Reference:
1. Aggarwal C, Thompson JC, Black TA, et al. Clinical implications of plasma-based genotyping with the delivery of personalized therapy in metastatic non-small cell lung cancer. JAMA Oncol. 2019;5(2):173-180.
MKTAMEA112020_015

NSCLC comprehensive results in 7 days from sample receipt at the laboratory

Test

with Guardant360® when patient is diagnosed with advanced NSCLC

Get results in 7 days

from sample receipt at the laboratory to guide treatment decisions

Take action

with first-line treatment

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