Shield™ blood test achieved overall 83% sensitivity and 90%
specificity and demonstrated early-stage detection in range with
other guideline-recommended non-invasive CRC screening
modalities
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology
company, today presented additional data from the ECLIPSE study at
2023 Digestive Disease Week (DDW) titled, “Clinical Validation of a
Cell-Free DNA Blood-Based Test for Colorectal Cancer in an Average
Risk Population” (Abstract #913e) showcasing the performance of its
blood-based technology to accurately detect early-stage colorectal
cancer (CRC).
The ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average
Patient Screening Episode) study is an over 20,000 patient
registrational study evaluating the performance of the Shield blood
test for detecting CRC in average-risk adults. The data presented
at DDW elaborates on the top-line data the company announced in
December 2022. Data presented today include:
- 83% sensitivity in detecting individuals with CRC;
- 81% sensitivity in detecting Stages I-III;
- 72% sensitivity in detecting localized disease (Stage I-II);
and
- Sensitivity by stage of 55% for Stage I, 100% for Stage II,
100% for Stage III, and 100% for Stage IV.
These results are in range with other guideline recommended
non-invasive screening modalities, where overall sensitivity ranges
from 74-92%.
The ability to detect cancers in early stages is an important
test parameter as the five-year survival rate is higher when caught
early.1 Shield’s sensitivity of detecting stage I-III cases and
localized cases (stage I-II) is in range with other
guideline-recommended non-invasive screening modalities (FIT
sensitivity in Stage I-III is 73%, and in localized cases is
70%).2
“There is a need for a more convenient and less invasive method
to screen for colorectal cancer, and an accurate blood test has the
potential to overcome many barriers patients face with traditional
screening methods," said Daniel Chung, MD, gastroenterologist at
Massachusetts General Hospital and Professor of Medicine at Harvard
Medical School. "The data presented today at DDW highlight the
promising results for blood-based CRC screening and the potential
for blood tests to help close the gap in screening adherence."
Colorectal cancer is the third leading cause of cancer related
death, but it is highly preventable and treatable if caught early.3
Despite multiple screening modalities available for CRC, 49 million
Americans remain unscreened.4 Screening rates are even lower in
minority and underserved populations.5 This was a key consideration
when conducting the ECLIPSE study, which reflects the diverse
population of the U.S. Study data includes 13% Black, 15% Hispanic
and 7% Asian American populations. Enrollment among Black Americans
was above average for a clinical trial, which is important given
the disproportionate impact of CRC on the black community.6
“Colorectal cancer screening saves lives, and yet, millions of
people are still not getting it done. Blood tests have the
potential to change that,” said Michael Sapienza, chief executive
officer of the Colorectal Cancer Alliance. “Offering patients a
convenient and minimally invasive option for getting screened that
can reach them where they are is a great step forward in helping to
close the screening gap.”
Since the commercial launch of the laboratory developed version
of the Shield test in May 2022, it has shown an adherence rate
greater than 90% in the real-world clinical setting.7 Shield’s
performance in detecting CRCs, combined with this real-world
adherence, suggests that Shield has the potential to detect more
CRCs at a curable stage than traditional modalities.8,9,10
“There is an unmet need in CRC screening for a high-performance
screening test that gets completed. The Shield test is spearheading
a new patient-preferred category in CRC screening and has the
potential to significantly increase overall screening rates,” said
AmirAli Talasaz, Guardant Health co-CEO. “We believe that as a
longitudinal screening test, taken every three years, Shield would
detect nearly all CRCs at a curable stage and will save many
lives.”
To view the full presentation, please visit the “Clinical
Studies - Key Publications” page of our website at
https://guardanthealth.com/clinical-studies/key-publications/.
About the Shield™ Test
The Shield test detects colorectal cancer signals in the
bloodstream from DNA that is shed by tumors, called circulating
tumor DNA (ctDNA). Specifically, the test identifies specific
characteristics of the DNA that may indicate the presence of
cancer.
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.
About Digestive Disease Week®
Digestive Disease Week® (DDW) is the largest international
gathering of physicians, researchers and academics in the fields of
gastroenterology, hepatology, endoscopy and gastrointestinal
surgery. Jointly sponsored by the American Association for the
Study of Liver Diseases (AASLD), the American Gastroenterological
Association (AGA), the American Society for Gastrointestinal
Endoscopy (ASGE) and the Society for Surgery of the Alimentary
Tract (SSAT), DDW is an in-person and online meeting from May 6-9,
2023. The meeting showcases more than 3,100 abstracts and hundreds
of lectures on the latest advances in GI research, medicine and
technology. More information can be found at www.ddw.org.
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 patients, and
Guardant Reveal™ for early-stage cancer patients. 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
and follow the company on LinkedIn and Twitter.
Guardant Health Forward-Looking Statement
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 any
current and periodic 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
- Cancer.net. Colorectal Cancer: Statistics. Accessed online May
8. 2023.
https://www.cancer.net/cancer-types/colorectal-cancer/statistics
- Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget
stool DNA testing for colorectal-cancer screening. NEJM. 2014.
- American Cancer Society. Key Statistics for Colorectal Cancer.
Accessed online May 8, 2023.
https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html
- Colorectal Cancer Facts & Figures. American Cancer Society.
2020-2022.
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2020-2022.pdf
- Colorectal Cancer Facts & Figures. American Cancer Society.
2020-2022.
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2020-2022.pdf
- U.S. Food & Drug Administration. 2020 Drug Trials Snapshots
Summary Report. FDA.gov website. Accessed online May 8, 2023.
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots
- Shield LDT internal data.
- Bretthauer M, Løberg M, Wieszczy P, et al.; NordICC Study
Group. Effect of colonoscopy screening on risks of colorectal
cancer and related death. N Engl J Med. 2022;387:1547-1556.
- Knudsen AB, Rutter CM, Peterse EFP, et al. Colorectal cancer
screening: An updated decision analysis for the U.S. Preventive
Services Task Force. Rockville (MD): Agency for Healthcare Research
and Quality; 2021a. Report No.: 202s.
- Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget
stool DNA testing for colorectal-cancer screening. NEJM. 2014.
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version on businesswire.com: https://www.businesswire.com/news/home/20230509005555/en/
Investor Contact: Alex Kleban
investors@guardanthealth.com +1 657-254-5417
Media Contact: Breen Weir press@guardanthealth.com +1
843-384-0095
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