Guardant360® - Guardant Health AMEA

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guideline-recommended
genomic information?

Get results fast.

Guide treatment decisions in 7 days^*
with Liquid Biopsy.

*Upon sample receipt in the laboratory

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.

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 400 peer-reviewed publications. It has been trusted by more than 12,000 oncologists with more than 500,000 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.¹

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).²

The Guardant360^®CDx test has also been approved by the US FDA as a companion diagnostic to identify patients with breast cancer who may benefit from treatment with ORSERDU™ (elacestrant).²

Reference:

FDA. (2020, August 11). FDA approves first liquid biopsy next-generation sequencing companion Diagnostic Test. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test
Guardant Health Data on File

Treatment Selection: For patients with advanced-stage 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.