FDA Advisory Committee Panel Strongly Recommends Approval of Shield™ Blood Test for Colorectal Cancer Screening as a Primary Non-Invasive Screening Option
2024年5月24日 - 8:03AM
ビジネスワイヤ（英語）
- The advisory committee offers valuable non-binding
recommendations for the FDA
- Blood test offers a convenient non-invasive screening option
that overcomes barriers associated with current non-invasive
screening tests
- Shield remains on track to become the first FDA-approved blood
test that meets performance requirements for Medicare
coverage1
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology
company, today announced the Molecular and Clinical Genetics Panel
of the U.S. Food and Drug Administration (FDA)’s Medical Devices
Advisory Committee has strongly recommended FDA approval of the
company’s Shield™ blood test for colorectal cancer (CRC) screening
in adults age 45 and older who are at average risk for the
disease.
The recommendation signals the advisory committee panel's
consensus on Shield's safety and effectiveness with its proposed
intended use, and their conclusion that its benefits as a primary
non-invasive screening option outweigh any potential risks. The
committee offers valuable perspective and non-binding
recommendations for the FDA to factor in alongside other
considerations during approval decisions. The FDA is expected to
decide whether to approve Shield later this year.
“The advisory committee’s strong support for the approval of
Shield reinforces the crucial role that a blood test option can
have in improving CRC screening rates for those at average risk,”
said AmirAli Talasaz, co-CEO of Guardant Health. “Despite the
importance of detecting colorectal cancer early, there are notable
barriers that can deter average-risk Americans from completing
existing screening methods. Shield effectively detects cancer at an
early stage when it is most treatable. Providing people with this
blood test alongside other non-invasive stool tests can increase
the rate of colorectal screening and potentially reduce preventable
CRC deaths.”
The advisory committee panel members voted on three questions
regarding the use of Shield in patients who meet the criteria
specified in the proposed indication. They voted 8 to 1 favorably
that there is reasonable assurance Shield is safe, 6 to 3 favorably
that there is reasonable assurance Shield is effective, and 7 to 2
favorably that the benefits of Shield outweigh its risks.
Colorectal cancer is the second-leading cause of cancer-related
deaths in the U.S.2 yet has a 91% five-year survival rate when
caught at stage I (localized).3 Despite this, one out of three
eligible Americans – 50 million people – are not being screened for
CRC.4 Current primary non-invasive screening options include
stool-based tests which have proven efficacy in detecting CRC;
however, studies have consistently found that barriers such as
handling stool and challenges performing the test impact
adherence.5,6,7,8 Shield offers patients a choice that can be
completed with a simple blood draw during a routine office
visit.
“Sadly, 76% of deaths caused by colorectal cancer occur in
individuals who are not up to date with their screening,”9 said
Daniel Chung, MD, gastroenterologist at Massachusetts General
Hospital and Professor of Medicine at Harvard Medical School.
“Clinical evidence and CRC screening guidelines acknowledge the
value of offering choice to individuals at average risk for CRC and
highlight the role of patient preference in test selection and CRC
screening completion.”
The panel’s recommendation is based on Guardant’s premarket
approval (PMA) application for Shield, including the results of the
pivotal ECLIPSE study evaluating the performance of the test for
detecting CRC in average-risk adults. Results from the study,
published in the March 2024 issue of The New England Journal of
Medicine, showed that Shield demonstrated 83% sensitivity for the
detection of CRC, with 90% specificity for advanced neoplasia. This
performance is within range of existing stool-based tests used as
primary CRC screening options, in which overall sensitivity ranges
from 67% to 92%.10
For more information about Shield for CRC screening, visit
BloodBasedScreening.com.
About the Shield test
The Shield test is a qualitative in vitro diagnostic test
intended to detect colorectal cancer derived alterations in
cell-free DNA from blood collected in the Guardant Blood Collection
Kit. Shield is intended for colorectal cancer screening in
individuals at average risk of the disease, age 45 years or older.
Patients with an “Abnormal Signal Detected” may have colorectal
cancer or advanced adenomas and should be referred for colonoscopy
evaluation. Shield is not a replacement for diagnostic colonoscopy
or for surveillance colonoscopy in high-risk individuals. The test
is performed at Guardant Health, Inc.
About Guardant Health
Guardant Health is a leading precision oncology 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.
References
1. The Shield test meets performance requirements for Medicare
coverage under NCD 210.3. 2. American Cancer Society. Key
Statistics for Colorectal Cancer. Accessed online May 21, 2024.
https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html
3. American Cancer Society. Survival Rates for Colorectal Cancer.
Accessed online May 21, 2024.
https://www.cancer.org/cancer/types/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html
4. National Colorectal Cancer Roundtable. 80% in Every Community.
https://nccrt.org/our-impact/80-in-every-community. Accessed May
21, 2024. 5. Raymond V, Foster G, Hong Y et al. Implementation of
Blood-Based Colorectal Cancer Screening: Real-World Clinical
Experience. ACG 2023 Annual Scientific Meeting Abstracts.
Vancouver, BC, Canada: American College of Gastroenterology. 6.
Denberg TD, Melhado TV, Coombes JM, et al. Predictors of
Nonadherence to Screening Colonoscopy. J Gen Intern Med.
2005;20(11):989-995. 7. Gellad ZF, Stechuchak KM, Fisher DA, et al.
Longitudinal Adherence to Fecal Occult Blood Testing Impacts
Colorectal Cancer Screening Quality. Am J Gastroenterol.
2011;106(6):1125-1134. 8. Inadomi JM, Vijan S, Janz NK, et al.
Adherence to Colorectal Cancer Screening: A Randomized Clinical
Trial of Competing Strategies. Arch Intern Med.
2012;172(7):575-582. 9. Doubeni, CA, et al. Modifiable Failures in
the Colorectal Cancer Screening Process and Their Association with
Risk of Death. Gastroenterology. 2019 Jan; 156(1): 63–74.e6.
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version on businesswire.com: https://www.businesswire.com/news/home/20240523474425/en/
Investor Contact: Zarak Khurshid
investors@guardanthealth.com
Media Contact: Mike Weist press@guardanthealth.com +1
650-647-3643
Guardant Health (NASDAQ:GH)
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過去 株価チャート
から 6 2023 まで 6 2024
