Tuesday, 13 April 2021

First liquid biopsy to receive FDA approval for profiling tumor mutations

11 August 2020 | News

This FDA approval represents a major turning point for the Guardant360 test

Image Credit: shutterstock.com

Image Credit: shutterstock.com

The Food and Drug Administration (FDA) of the United States approved the liquid biopsy by Guardant Health, the companion diagnostic Guardant360 ®, for profiling of tumor mutations in patients of all kind’s solid cancers.

For Singapore-based Guardant Health Asia, Middle East and Africa (AMEA), this FDA approval represents a major turning point for the Guardant360 test. Currently, liquid biopsy is marketed in 41 countries in the AMEA region. 

For patients with advanced cancer, this FDA approval lends even more credibility to the test and its ability to provide comprehensive genomic profiling information that is critical to the treatment of their cancer.

Mr. Simranjit Singh, Managing Director of Guardant Health AMEA, said that, “This FDA approval is an important step for us and it will certainly strengthen our efforts to offer Guardant360 as the best liquid biopsy option in the AMEA region. We remain committed to making the Guardant360 test available to as many patients with advanced cancer as possible so that they can benefit from full genotyping and have every chance of receiving the right treatment for their cancer.”

Guardant Health AMEA hopes to accelerate the wider adoption of guideline-recommended genomic profiling in clinical practice among medical oncologists so that patients with advanced cancer in the AMEA region can benefit from reliable and complete liquid biopsies such as Guardant360 and be processed quickly and accurately.

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