SINGAPORE, Aug. 8, 2020 /PRNewswire/ -- 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.
About Guardant Health AMEA
Guardant Health AMEA is a joint venture between SoftBank
and Guardant Health, 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 is designed to leverage its capabilities
in technology, clinical development, regulatory and reimbursement
to drive commercial adoption, improve patient clinical outcomes and
lower healthcare costs. In pursuit of its goal to manage cancer
across all stages of the disease, Guardant Health has
launched multiple liquid biopsy-based tests, Guardant360 and
GuardantOMNI, for advanced stage cancer patients, which fuel its
LUNAR development programs for recurrence and early detection.
Since its launch in 2014, Guardant360 has been ordered used by more
than 7,000 oncologists and over 60 biopharmaceutical companies.
Visit us online at www.guardanthealthamea.com.
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