Guardant Health Announces Tentative Date of FDA Advisory Panel Review of Shield™ Blood Test
19 Décembre 2023 - 10:05PM
Business Wire
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology
company, today announced that the U.S. Food and Drug
Administration’s Molecular and Clinical Genetics Panel of the
Medical Devices Advisory Committee is tentatively scheduled to
review the premarket approval application (PMA) for the company’s
Shield™ blood test to screen for colorectal cancer on March 28,
2024. The date and details of the meeting are subject to
confirmation by the FDA and publication in the Federal
Register.
Guardant Health submitted the final module of its PMA for Shield
on March 10, 2023. The submission includes data from the company’s
positive ECLIPSE study, an over 20,000-patient registrational study
evaluating the performance of its blood test for detecting
colorectal cancer in average-risk adults.
“We welcome the opportunity to engage in a discussion with key
opinion leaders about our study results and the power of Shield in
closing the screening gap once FDA approved,” said AmirAli Talasaz,
co-CEO of Guardant Health. “The proposed timing of the meeting is
in line with our expectation to complete the PMA process and launch
Shield IVD in 2024.”
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
relating to Guardant Health’s future results, or regarding the
potential benefits and advantages of Guardant Health’s platforms,
assays and tests, which involve risks and uncertainties that could
cause Guardant Health’s 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231219982476/en/
Investor Contact: investors@guardanthealth.com
Media Contact: Matt Burns press@guardanthealth.com +1
518-423-5907
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