- Shield is first blood test approved by FDA as a primary
screening option for colorectal cancer and that meets performance
requirements for Medicare coverage
- Blood test offers easy, convenient and pleasant screening
option with potential for improving colorectal cancer screening
rates
- Guardant Health to host investor conference call and webcast
Monday, July 29, at 8:30 a.m. ET / 5:30 a.m. PT
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology
company, today announced the U.S. Food and Drug Administration
(FDA) has approved 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. It is the first blood test to be
approved by the FDA as a primary screening option for CRC, meaning
healthcare providers can offer Shield in a manner similar to all
other non-invasive methods recommended in screening guidelines.
Shield is also the first blood test for CRC screening that meets
the requirements for Medicare coverage.1
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240725240089/en/
Shield is a blood test from Guardant
Health for colorectal cancer screening in average-risk individuals
45 and older. (Photo: Business Wire)
Colorectal cancer is the second-leading cause of cancer-related
death in the U.S., even though it is highly treatable if caught
early.2 The American Cancer Society estimates that more than
150,000 people will be diagnosed with CRC in 2024 and the disease
will be responsible for more than 53,000 deaths.3 More than three
out of four individuals who die from CRC are not up to date with
their screening.4 Early detection is critical. When colon cancer is
found at an early stage before it has spread, the five-year
relative survival rate is 91%. If the cancer has spread to distant
parts of the body, the five-year relative survival rate is
14%.5
The CRC screening rate in the U.S. is only about 59%, which
falls well below the National Colorectal Cancer Roundtable’s goal
of 80% for eligible individuals.6 More than one out of three
eligible Americans – over 50 million people – do not complete CRC
screening, often due to the perception that other available
options, such as colonoscopy or stool-based tests, are invasive,
unpleasant or inconvenient.7
“The persistent gap in colorectal cancer screening rates shows
that the existing screening options do not appeal to millions of
people,” said Daniel Chung, MD, gastroenterologist at Massachusetts
General Hospital and Professor of Medicine at Harvard Medical
School. “The FDA's approval of the Shield blood test marks a
tremendous leap forward, offering a compelling new solution to
close this gap. This decision will help make screening tests more
broadly accessible and propel blood-based testing and CRC screening
into a new era. With increased screening rates and early cancer
detection, many more lives can be saved.”
The Shield blood test is the result of over 10 years of research
and development, including collaboration between Guardant Health
and leading health organizations globally. Since the commercial
introduction of the LDT (laboratory developed test) version in May
2022, the overall adherence rate for the Shield test has been more
than 90%, meaning more than 90% of patients who were prescribed the
test in a real-world clinical setting completed it.8 In contrast,
studies show only 28-71% of patients who are prescribed other
screening methods, such as colonoscopy or a stool test, complete
them.9-12 Primary care physicians can have patients complete a
Shield test with a simple blood draw during a routine office visit,
providing a convenient and more pleasant alternative screening
method that doesn’t require the special preparation, dietary
changes, time and discomfort associated with colonoscopy or the
unpleasantness of handling stool.
“The FDA approval of the Shield test is a significant victory
for patients and an important milestone in Guardant Health’s
mission to conquer cancer with data. Shield can help improve
colorectal cancer screening rates so we can detect more cancers at
an early stage, when they are treatable,” said AmirAli Talasaz,
Guardant Health co-CEO. “We are now getting ready to launch this
test in the near future and are very excited to empower physicians
with a viable blood-based screening option to tailor the screening
regimen to the unique needs of their patients.”
The FDA decision follows a strong recommendation for approval by
an Advisory Committee panel in May 2024. The approval was based on
results of ECLIPSE, a 20,000+-patient registrational study
evaluating the performance of the test for detecting CRC in
average-risk adults. Designed to reflect the diverse population of
the U.S., the study was conducted at more than 200 clinical trial
sites in rural and urban communities across 37 states. Results from
the study, published in the March 14, 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 current
guideline-recommended non-invasive screening methods, in which
overall CRC sensitivity ranges from 74% to 92%.13
“In addition to performance, a screening test’s value should be
measured by how accessible it is, and how likely people are to use
it,” said Michael Sapienza, CEO of the Colorectal Cancer Alliance.
“Guardant Health’s Shield test checks all three of these boxes and
is truly a welcomed addition to the screening options currently
available. Giving people choice, and offering a blood test that can
reach those in harder-to-screen communities, will undoubtedly be a
huge step forward in our battle against colorectal cancer.”
“This is a promising step toward making more convenient tools
available to detect colorectal cancer early while it is more easily
treated,” said 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."
“Most people in my situation know we’re supposed to get screened
for colon cancer,” said Dennis Barnes, a 55-year-old attorney whose
physician had recommended a colonoscopy. But despite his best
intentions, he had never scheduled one. “It’s hard to find the time
to schedule it if you have a busy life and a demanding job,” he
said. When his doctor told him about Shield, he agreed to have the
blood test and was fortunate to have the result come back normal.
“I realized I had taken quite a risk by waiting so long to screen.
The Shield test is a much more pleasant way to screen, and the
convenience of it makes getting screened pretty much a
no-brainer.”
"I was in for a routine physical and my doctor asked when I had
my last colonoscopy," said John Gormly, a 77-year-old business
executive in Newport Beach, California. "I said it's been a long
time, so he offered to give me the Shield blood test. A few days
later the result came back positive, so he referred me for a
colonoscopy. It turned out I had stage II colon cancer. The tumor
was removed, and I recovered very quickly. Thank God I had taken
that blood test."
Shield is available for eligible individuals by prescription
through a doctor or other healthcare professional and is expected
to be covered for eligible Medicare beneficiaries. Commercial
insurance coverage for patients eligible for CRC screening will
continue to expand following anticipated future guideline inclusion
by the American Cancer Society and the U.S. Preventive Services
Task Force (USPSTF).
For complete product information about the Shield blood test for
CRC screening, including full safety information, visit
ShieldCancerScreen.com.
Webcast Details
Guardant Health will host an investor conference call and
webcast Monday, July 29, at 8:30 a.m. ET / 5:30 a.m. PT to discuss
the FDA approval for Shield. A link to live audio of the webcast
will be available on the “Investors” section of the company website
at investors.guardanthealth.com or directly at this link. The
webcast will be archived and available for replay after the
event.
About Shield
Shield is a non-invasive, blood-based screening test that
detects alterations associated with colorectal cancer in the blood.
It is intended as a screening test for individuals at average risk
for the disease, age 45 or older, and is not intended for
individuals at high risk for colorectal cancer. The Shield test can
be considered in a manner similar to guideline-recommended
non-invasive CRC screening options and can be completed during any
healthcare visit. A positive Shield result raises concern for the
presence of colorectal cancer or advanced adenoma and the patient
should be referred for colonoscopy evaluation.
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 and
accelerating new cancer therapies 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 treatment selection 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 8, 2023.
https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html
3. American Cancer Society. Cancer Facts & Figures 2024.
Atlanta: American Cancer Society; 2024. 4. Doubeni, C, 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. 5. American Society of Clinical Oncology.
Colorectal Cancer: Statistics.
https://www.cancer.net/cancer-types/colorectal-cancer/statistics#.
Accessed April 23, 2024. 6. American Cancer Society National
Colorectal Cancer Roundtable. 80% in Every Community.
https://nccrt.org/our-impact/80-in-every-community/. Accessed
February 15, 2024. 7. Rich T, Raymond V, Lang K. Where are we
today? Efforts to understand strategies and barriers to physician
issuance of a recommendation for colorectal cancer screening: a
systematic review. Gastroenterology. 2020;158(6 suppl 1):S-918.
doi:10.1016/S0016-5085(20)32981-4. 8. 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. 9. Denberg TD, Melhado TV, Coombes JM, et al.
Predictors of nonadherence to screening colonoscopy. J Gen Intern
Med. 2005;20(11):989-995. 10. 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. 11. 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. 12. Exact Sciences. Third quarter 2019 webcast
and conference call. Updated October 29, 2019. Accessed December
17, 2021.
https:/investor.exactsciences.com/investor-relations/events-and-presentations/event-details/2019/Third-Quarter-2019-Webcast-Conference-Call/default.aspx
13. Chung DC, Gray DM, Singh H et al. A Cell-free DNA Blood-Based
Test for Colorectal Cancer Screening. N Engl J Med
2024;390:973-83.
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version on businesswire.com: https://www.businesswire.com/news/home/20240725240089/en/
Investor Contact: Zarak Khurshid
investors@guardanthealth.com
Media Contact: Mike Weist press@guardanthealth.com +1
317-371-0035
Guardant Health (NASDAQ:GH)
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Guardant Health (NASDAQ:GH)
過去 株価チャート
から 7 2023 まで 7 2024
