FDA Advisory Panel Review of Guardant Health’s Shield™ Blood Test to Screen for Colorectal Cancer to Be Held on May 23
April 22 2024 - 8:52AM
Business Wire
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 Medical Devices Advisory
Committee is scheduled to review the premarket approval (PMA)
application for the company’s Shield™ blood test for colorectal
cancer (CRC) screening on Thursday, May 23, 2024.
“We look forward to discussing with the FDA Advisory Committee
and its panel of experts the clinical data from our ECLIPSE study
and the potential for the Shield blood test to overcome the
barriers of current screening methods and offer a new, more
convenient screening option that will detect colorectal cancer in
the early stages, when it is most treatable,” said AmirAli Talasaz,
co-CEO of Guardant Health.
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 in
its other 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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Investor Contact: Zarak Khurshid
investors@guardanthealth.com
Media Contact: Michael Weist press@guardanthealth.com +1
317 371 0035
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