- Guardant360® CDx is a comprehensive genomic
profiling blood test that provides critical information to help
inform personalized treatment decisions for patients with advanced
solid cancers
- The liquid biopsy test is also approved as a companion
diagnostic for TAGRISSO® (osimertinib) in non-small cell
lung cancer
- This is the first blood test to be approved by Singapore's Health Sciences Authority for
comprehensive genomic profiling for all solid
tumors
SINGAPORE, May 30, 2023 /PRNewswire/ -- Guardant Health,
Inc. (Nasdaq: GH) announced today that Singapore's Health Sciences Authority
(HSA) has granted regulatory approval of Guardant360®
CDx, a liquid biopsy test for tumor mutation profiling, also known
as comprehensive genomic profiling (CGP), in patients with advanced
solid cancers. The Guardant360 CDx test was also approved as a
companion diagnostic to identify patients with advanced non-small
cell lung cancer (NSCLC) with epidermal growth factor receptor
(EGFR) alterations who may benefit from treatment with
TAGRISSO® (osimertinib).
Guardant360 CDx is the first blood test to be approved by
Singapore's HSA for comprehensive
genomic profiling for all solid tumors. Since being introduced as a
laboratory developed test (LDT), the Guardant360 liquid biopsy has
become widely accepted for blood-based CGP with more than 400
peer-reviewed publications.
"We are delighted to receive regulatory approval from HSA for
our Guardant360 CDx test, as it supports the value liquid
biopsy brings to oncologists and the patients they treat," said
Simranjit Singh, CEO of Guardant
Health AMEA. "With a simple blood draw from the patient, the
Guardant360 CDx test provides CGP results in approximately seven
days from receipt of the blood sample in the laboratory, enabling
physicians to make faster treatment decisions compared to tissue
biopsies. Our hope is that this approval will drive clinical
adoption of liquid biopsy testing in Singapore and enable more patients to be
matched to potentially life-changing precision medicines."
In 2020, over 23,600 people in Singapore were diagnosed with cancer and there
were slightly over 12,000 cancer-related deaths. The most prevalent
cancer types among men and women in Singapore include breast (15.5%), colorectal
(15.1%) and lung (12.3%) cancer[1]. According to the
Singapore Cancer Registry Annual Report 2020, over 70% of all lung
cancer cases among men and women were diagnosed at the advanced
stage[2]. Pancreatic, stomach and colorectal cancer
cases among men and women were also diagnosed at the advanced stage
respectively (71.9%, 62.1%, 58.3%)[2]. To improve cancer
outcomes in Singapore, Guardant
Health AMEA is currently collaborating with National Cancer Centre
Singapore and National University
Cancer Institute, Singapore for
several clinical trials using the Guardant360 test in efforts to
accelerate clinical trial enrollment by identifying genomic
biomarkers in patients with cancer.
The Guardant360 CDx test was the first blood test to be approved
by the U.S. Food and Drug Administration (FDA) for comprehensive
genomic profiling for all solid tumors, and it is now FDA approved
as a companion diagnostic test for four targeted therapies in NSCLC
and one in advanced breast cancer. In March
2022, the test was also granted regulatory approval by
Japan's Ministry of Health, Labour
and Welfare for tumor mutation profiling in patients with advanced
solid cancers as well as a companion diagnostic to identify
patients with microsatellite instability-high (MSI-High) solid
tumors who may benefit from Keytruda® (pembrolizumab) and patients
with MSI-High advanced colorectal cancer who may benefit from
Opdivo® (nivolumab). In addition, Guardant Health is currently
involved in multiple studies with drug development companies to
develop Guardant360 CDx as a companion diagnostic for new
therapies.
About Guardant360® CDx
The Guardant360 CDx test provides comprehensive genomic results
from a simple blood draw in seven days, helping oncologists move
beyond the limitations of tissue biopsies to rapidly obtain
clinically relevant information in time to match patients to the
optimal personalized treatment.
The first FDA-approved blood test for complete genomic testing,
Guardant360 CDx is approved as a companion diagnostic to identify
patients with non-small cell lung cancer who may benefit from
treatment with TAGRISSO® (osimertinib),
RYBREVANT® (amivantamab-vmjw),
ENHERTU® (fam-trastuzumab deruxtecan-nxki) or
LUMAKRAS™ (sotorasib). It is also FDA approved to identify advanced
breast cancer patients with ESR1 mutations who may
benefit from treatment with ORSERDU™ (elacestrant). For more
information, visit guardant360cdx.com.
Since being introduced, the Guardant360 test has become widely
accepted for blood-based comprehensive genomic profiling, with more
than 400 peer-reviewed publications. It has been trusted by more
than 12,000 oncologists, with more than 300,000 tests performed to
date, and is broadly covered by Medicare and many private payers in
the U.S., representing over 300 million lives.
About Guardant Health AMEA
Guardant Health AMEA is a wholly owned subsidiary of Guardant
Health, Inc., a leading precision oncology company focused on
helping conquer cancer globally through use of its proprietary
tests, vast data sets and advanced analytics. The Guardant Health
oncology platform leverages capabilities to drive commercial
adoption, improve patient clinical outcomes and lower healthcare
costs across all stages of the cancer care continuum. Guardant
Health has commercially launched Guardant360®,
Guardant360® CDx, Guardant360 TissueNext™, Guardant360
Response™, and GuardantINFINITY™ tests for patients with
advanced-stage cancer, and Guardant Reveal™ for patients with
early-stage cancer. The Guardant Health screening portfolio,
including the commercially launched Shield™ test, aims to address
the needs of individuals eligible for cancer screening. For more
information, visit guardanthealthamea.com and follow the
company on LinkedIn, Twitter and Facebook.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of federal securities laws, including statements
regarding the potential utilities, values, benefits and advantages
of Guardant Health's liquid biopsy tests or assays, which involve
risks and uncertainties that could cause the actual results to
differ materially from the anticipated results and expectations
expressed in these forward-looking statements. These statements are
based on current expectations, forecasts and assumptions, and
actual outcomes and results could differ materially from these
statements due to a number of factors. These and additional risks
and uncertainties that could affect Guardant Health's financial and
operating results and cause actual results to differ materially
from those indicated by the forward-looking statements made in this
press release include those discussed under the captions "Risk
Factors" and "Management's Discussion and Analysis of Financial
Condition and Results of Operation" and elsewhere in its Annual
Report on Form 10-K for the year ended December 31, 2021, and any current and periodic
reports filed with the Securities and Exchange Commission
thereafter. The forward-looking statements in this press release
are based on information available to Guardant Health as of the
date hereof, and Guardant Health disclaims any obligation to update
any forward-looking statements provided to reflect any change in
its expectations or any change in events, conditions, or
circumstances on which any such statement is based, except as
required by law. These forward-looking statements should not be
relied upon as representing Guardant Health's views as of any date
subsequent to the date of this press release.
References
[1]. GLOBOCAN 2020 statistics available at
https://gco.iarc.fr/today/data/factsheets/populations/702-singapore-fact-sheets.pdf
accessed on 20 May 2023
[2]. Singapore Cancer Registry Annual Report
2020 statistics available at
https://nrdo.gov.sg/publications/cancer accessed on
20 May 2023
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