- Study shows blood-based cancer screening test detects 83% of
people with colorectal cancer with specificity of 90%
- Results pave the way for first potential FDA-approved blood
test for colorectal cancer screening to meet requirements for
Medicare coverage
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology
company, today announced that results from the ECLIPSE study
showing the effectiveness of its ShieldTM blood test for detecting
colorectal cancer (CRC) in average-risk adults will be published in
the March 14 issue of The New England Journal of Medicine.
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the full release here:
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Shield (TM) from Guardant Health is a
blood test for colorectal cancer screening for adults age 45-84 who
are at average risk. (Photo: Business Wire)
“Over 50 million eligible Americans do not get recommended
screenings for colorectal cancer, partly because current screening
methods are inconvenient or unpleasant,” said AmirAli Talasaz,
Guardant Health co-CEO. “We believe the publication of the ECLIPSE
study in The New England Journal of Medicine, one of the world’s
leading medical journals, is an endorsement of the quality of our
clinical data and the potential value of the Shield test. We are
confident that offering an accurate blood test has the potential to
significantly reduce preventable colorectal cancer deaths.”
One of the largest studies of its kind, ECLIPSE (Evaluation of
ctDNA LUNAR Assay In an Average Patient Screening Episode) is a
20,000+-patient registrational study to evaluate the performance of
Shield compared to a screening colonoscopy. The Shield test detects
colorectal cancer signals in the bloodstream from DNA that is shed
by tumors, called circulating tumor DNA (ctDNA).
Highlights of the study results to be published in The New
England Journal of Medicine* show that Shield demonstrated:
- 83% sensitivity in detecting individuals with CRC
- 88% sensitivity in detecting pathology-confirmed Stages
I-III
- Sensitivity by stage of:
- 65% for pathology-confirmed Stage I; 55% for clinical Stage
I
- 100% for Stage II
- 100% for Stage III
- 100% for Stage IV
These results are on par with the performance of other
guideline-recommended non-invasive screening modalities, where
overall sensitivity in detecting colorectal cancer ranges from 74%
to 92%.1
“More than 3 out of 4 Americans who die from colorectal cancer
are not up to date with their recommended screening,2 highlighting
the need for a more convenient and less invasive screening method
that can overcome barriers associated with traditional options,”
said Daniel Chung, MD, gastroenterologist at Massachusetts General
Hospital and Professor of Medicine at Harvard Medical School. “The
ECLIPSE study results published today support the use of a blood
test as a screening option that could help overcome these barriers
and improve CRC screening rates."
Publication of ECLIPSE follows Guardant Health’s submission of
its premarket approval (PMA) application to the U. S. Food and Drug
Administration (FDA) for Shield, which included key data points
from the study. Since the launch of the lab-developed version of
the Shield test in May 2022, it has been used by more than 20,000
people and more than 90% of patients who were prescribed the test
in the real-world clinical setting completed it. One recent study
showed that CRC screening rates tripled among adults who had
declined prior CRC screening when they were offered Shield. The
test’s sensitivity in detecting CRC, combined with this real-world
adherence, suggests that Shield has the potential to detect more
CRCs at a curable stage than traditional screening
methods.3,4,5,6
“Colorectal cancer is highly treatable if caught in the early
stages, yet more than 50 million people in the U.S. are still not
completing their recommended screening with the methods available
today,” said Chris Evans, president of the Colon Cancer Coalition.
“This publication gets us one step closer to having an additional
option to offer patients – one that is both convenient and
accessible—and will help us close the screening gap.”
Colorectal cancer is the second-leading cause of cancer deaths
in the U.S. The American Cancer Society estimates that more than
150,000 people will be diagnosed with CRC in 20247 and it is
expected to become the leading cause of cancer-related deaths by
2030 in adults aged 20-49.8 More than 75% of people who die from
CRC are not up to date with recommended screening,9 often due to
the perception that current methods such as colonoscopy or
stool-based tests are invasive, time-consuming and inconvenient.
Early detection, however, is crucial. When colon cancer is found at
an early stage before it has spread, the 5-year relative survival
rate is 91%. If the cancer has spread to distant parts of the body,
the 5-year survival rate is 13%.
“The results of the study are a promising step toward developing
more convenient tools to detect colorectal cancer early while it is
more easily treated,” said corresponding author William M. Grady,
MD, a gastroenterologist at Fred Hutchinson Cancer Center. “The
test, which has an accuracy rate for colon cancer detection similar
to stool tests used for early detection of cancer, could offer an
alternative for patients who may otherwise decline current
screening options."
* Representatives of the media who are not able to access the
article content can contact press@guardanthealth.com.
About the ECLIPSE study
ECLIPSE is a prospective registrational study to evaluate the
performance of Guardant Health’s blood test in detecting signs of
CRC compared to a screening colonoscopy in average-risk adults
between the ages of 45 and 84 from across the U.S. The ECLIPSE
study included more than 200 clinical trial sites in rural and
urban communities across 34 states. Study data includes 12% Black,
13% 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.10
About Shield
The Shield test for colorectal cancer screening 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 Guardant Health
Guardant Health is a leading precision medicine company focused
on guarding wellness and giving every person more time free from
cancer. Founded in 2012, Guardant is transforming patient care by
providing critical insights into what drives disease through its
advanced blood and tissue tests, real-world data and AI analytics.
Guardant tests help improve outcomes across all stages of care,
including screening to find cancer early, monitoring for recurrence
in early-stage cancer, and helping doctors select the best
treatment for patients with advanced cancer. For more information,
visit guardanthealth.com and follow the company on LinkedIn, X
(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, 2023, 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.
Disclosures
Dr. Chung and Dr. Grady are paid members of Guardant Health’s
ECLIPSE Steering Committee. Both advised on the design and
procedure of the clinical study and data analysis.
References
- Chung, D., et al. Clinical Validation of a Cell-Free DNA
Blood-Based Test for Colorectal Cancer in an Average Risk
Population. Abstract #3910067. Digestive Disease Week 2023; May
6-9, 2023; Chicago, IL.
- Gastroenterology. 2019 Jan; 156(1): 63–74.e6.
www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=30268788.
Accessed March 6, 2024.
- 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. N Eng J Med.
2014.
- Coronado GD, Jenkins CL, Shuster E, et al. Blood-based
colorectal cancer screening in an integrated health system: a
randomised trial of patient adherence. Gut. Epub ahead of print:23
January 2024. doi:10.1136/gutjnl-2023-330980.
- American Cancer Society: Colorectal Cancer Key Statistics.
www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html
Accessed online Feb 5, 2021.
- Colorectal Cancer Alliance.
https://colorectalcancer.org/resources-support/community-support/young-onset-support/young-onset-crc-facts.
Accessed March 13, 2024.
- Doubeni CA, Fedewa SA, Levin TR, et al. Modifiable Failures in
the Colorectal Cancer Screening Process and Their Association With
Risk of Death. Gastroenterology 2019;156:63–74.
- U.S. Food & Drug Administration. 2022 Drug Trials Snapshots
Summary Report.
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots.
Accessed December 18, 2023.
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Investor Contact: investors@guardanthealth.com
Media Contact: Michael Weist press@guardanthealth.com +1
650-647-3643
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