First liquid biopsy to receive FDA Approval for comprehensive tumor mutation profiling across all solid cancers, Guardant Health’s Guardant360® CDx, advancing precision oncology in Asia, Middle East and Africa

August 7, 2020

SINGAPORE — The U.S. Food and Drug Administration (FDA) has approved Guardant Health’s liquid biopsy, Guardant360 CDx, for tumor mutation profiling in patients across all solid cancers.

For Guardant Health Asia, Middle East and Africa (AMEA), this FDA approval represents a landmark achievement for the Guardant360® test. Currently, the liquid biopsy is commercially available in 41 countries in AMEA. For advanced cancer patients, this FDA approval lends even greater credibility to the test and its ability to provide comprehensive genomic profiling information that is critical to their cancer treatment.

“This FDA approval is a significant milestone for us and it will certainly boost our efforts in offering Guardant360 as the preferred liquid biopsy option in AMEA. We remain committed to making the Guardant360 test available to as many advanced cancer patients as possible so that they can undergo complete genotyping and have the best opportunity to receive the right treatment for their cancer,” said Mr Simranjit Singh, Chief Executive Officer of Guardant Health AMEA.

“The US FDA approval validates the technology behind the Guardant360 assay that we offer to advanced stage cancer patients in AMEA. Treatment guidelines recommend testing for more than 20 different genomic biomarkers. Evaluating each mutation individually wastes time and delays treatment. With Guardant360, physicians and patients can feel confident that relevant genes are being assessed with a single blood test. Results are available within 7 days from receipt in the laboratory. This will help more patients start treatment sooner with appropriate precision cancer medicines,” said Dr. Steve Olsen, Chief Medical Officer of Guardant Health AMEA.

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