SINGAPORE, Nov. 13, 2023 /PRNewswire/ -- Guardant Health,
Inc. (Nasdaq: GH), a leading precision oncology company, announced
that it has launched its blood-based colorectal cancer screening
test, ShieldTM, in collaboration with Samsung Medical
Center in South Korea.
Colorectal cancer (CRC) is one of the most commonly diagnosed
cancers and the third-leading cause of cancer-related deaths in
South Korea.1,2
Guardant Health's Shield test, which can be used for regular CRC
screening in eligible individuals, is an innovative test that can
detect cancer in its early stages by analysing circulating tumour
DNA (ctDNA), which is produced when tumours shed small pieces of
their genetic material into the bloodstream. In the pivotal
ECLIPSE study, which enrolled over 20,000 patients, the Shield test
achieved 83% sensitivity for the detection of colorectal cancer in
average-risk adults in the U.S., with specificity of
90%.3
Early detection is essential to reduce colorectal cancer
mortality. Colonoscopy and faecal tests are generally used for
early detection, however, compliance rates for these screening
tests are low and have remained stagnant since 2014.4
The primary reasons for lack of compliance with CRC screening
recommendations include not having any symptoms of CRC, lack of
time for a colonoscopy procedure, which requires a few days of
preparation, and fear of an invasive colonoscopy
procedure.4 Since the launch of the lab-developed
version of the Shield test in May
2022, it has shown approximately 90% adherence in a
real-world clinical setting, demonstrating the value of blood-based
screening to increase adherence to recommended screening
protocols.5
"Colorectal cancer rarely has symptoms in its early stages, and
by the time symptoms appear, the disease has often progressed
considerably. Therefore, early detection through a screening test
is critical," said Health Promotion Center of Samsung Medical
Center. "The Shield blood test can broaden the range of choices for
colorectal cancer screening. We are confident that by introducing a
high-quality blood-based screening test, we can meet the needs of
both patients and healthcare providers and help improve screening
compliance."
"We are pleased to be able to help address the high rates of
colorectal cancer in South Korea
by introducing the Shield test at Samsung Medical Center," said
Simranjit Singh, Chief Executive
Officer of Guardant Health Asia, Middle
East & Africa. "We are
confident that this revolutionary screening test will help
healthcare professionals detect colorectal cancer early, when it's
most treatable, with a simple blood draw."
About the Shield Test
The Shield test detects
colorectal cancer signals in the bloodstream from DNA that is shed
by tumours, called ctDNA. Specifically, the test identifies certain
characteristics of the DNA that may indicate the presence of
cancer. The clinical performance of the Shield assay in detecting
colorectal cancer in average-risk individuals was validated in
ECLIPSE, a registrational study that enrolled over 20,000 patients
in the U.S. The test demonstrated 83% sensitivity for the detection
of colorectal cancer with specificity of 90%. The test also
demonstrated 13% sensitivity in detecting advanced adenomas.
Shield is commercially available for eligible individuals by
prescription only through healthcare professionals. This LDT
(Laboratory Developed Test) is intended to be complementary to, and
not a replacement for, current recommended CRC screening methods. A
negative result does not rule out the presence of cancer. Patients
with an abnormal blood-based screening result should be referred
for a diagnostic colonoscopic evaluation. More information about
the Shield test is available at bloodbasedscreening.com. For
more information about the ECLIPSE study (NCT04136002), visit
www.clinicaltrials.gov.
About Guardant Health
Guardant Health is 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 advanced stage cancer, and
Guardant Reveal™ for 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 guardanthealth.com or
guardanthealthamea.com.
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, 2022, and in
its other reports filed with or furnished to 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
- National Cancer Information Center (NCIC). Cancer in statistics
available at https://www.cancer.go.kr/ accessed on 12 October 2023.
- Statistics Korea (2023). 2022 Cause-of-death statistics
available
at https://www.kostat.go.kr/board.es?mid=a10301060200&bid=218&act=view&list_no=427216
accessed on 12 October 2023.
- Chung, et al. Digestive Diseases Week 2023. Abstract #913e
available at
https://guardanthealth.com/wp-content/uploads/ChungGrady_DDW_Abstract-913e_FINAL.pdf
accessed on 12 October 2023
- Park B, Lee YY, Song SY, Shin HY, Suh M, Choi KS, Jun
JK. Trends of Colorectal Cancer Screening Rates in Korea:
Korean National Cancer Screening Survey 2005–2020. Gut and
Liver 2022; 16:930-941.
https://doi.org/10.5009/gnl210419
- Shield LDT internal data on file. Guardant Health,
Inc.
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