Guardant Health Launches Real-World Clinical-Genomic Platform to Accelerate Precision Oncology Drug Development
June 23 2020 - 7:55AM
Guardant Health, Inc. (Nasdaq: GH), a leading precision
oncology company, addresses the challenges of developing new
precision oncology medicines by unveiling the GuardantINFORM™
platform featuring an extensive clinical-genomic liquid
biopsy dataset of advanced cancer patients.
The GuardantINFORM platform is intended to help accelerate
research and development of the next generation of cancer
therapeutics by offering biopharma partners an in-silico platform
that combines de-identified longitudinal clinical information and
genomic data collected from the Guardant360® liquid biopsy test
—over 100,000 tests to date. This robust dataset offers real-world
insights into anti-cancer therapy use in the clinic, tumor
evolution, and treatment resistance throughout each patient’s
treatment journey for many advanced solid tumor cancers including
non-small cell lung, breast, colon, and prostate. The most notable
applications for the GuardantINFORM platform include:
- Targeted drug development: Identify,
characterize, and prioritize cohorts of patients with
biomarker-defined cancers and in need of treatment options for
potential new drug development indications and label expansions.
- Clinical trial optimization: Incorporate
real-world clinical-genomic data into clinical trial design,
control arm simulation, clinical operations activities, and
clinical development decision-making.
- Post-marketing studies: Conduct health
outcomes and safety studies of on- and off-label use of marketed
therapies using real-world market insights and estimates of
progression-free and overall survival in biomarker-defined
cancers.
“The GuardantINFORM platform represents an important milestone
in our mission to conquer cancer with data, with liquid biopsy
samples from more than 100,000 patients accumulated over the past
five years,” said Helmy Eltoukhy, Guardant Health co-founder and
CEO. “The richness of this clinical-genomic platform, combined with
the complexity and diversity of all metastatic solid tumors, offers
researchers more immediate access to real-world drug resistance and
tumor evolution information which we believe will accelerate their
development of novel therapeutics and new indications for
patients.”
Recent data presented at the AACR Virtual Annual Meeting II
quantify1 the robustness of the GuardantINFORM real-world
clinical-genomic platform, and its potential to support drug
development using circulating tumor DNA (ctDNA) as a valuable
alternative to serial tissue testing. In a cohort of patients who
underwent Guardant360 serial ctDNA testing, test results were
linked to de-identified medical and pharmacy claims; a
robust longitudinal view of the diagnoses, treatments, and clinical
outcomes was accessible for the majority of patients.1 The
availability of clinical-genomic information following systemic
therapy confirms that this platform can serve as a valuable
resource for precision oncology drug development researchers to
evaluate drug resistance and tumor evolution in patients with
advanced cancer in a real-world setting.
About Guardant Health
Guardant Health is a leading precision
oncology company focused on helping conquer cancer globally through
use of its proprietary blood tests, vast data sets and advanced
analytics. The Guardant Health Oncology Platform leverages
capabilities to drive commercial adoption, improve patient clinical
outcomes and lower healthcare costs across all stages of the cancer
care continuum. Guardant Health has launched liquid
biopsy-based Guardant360 and GuardantOMNI tests for advanced stage
cancer patients. These tests fuel development of its LUNAR program,
which aims to address the needs of early stage cancer patients with
neoadjuvant and adjuvant treatment selection, cancer survivors with
surveillance, asymptomatic individuals eligible for cancer
screening and individuals at a higher risk for developing cancer
with early detection.
Forward-looking Statements
This press release contains forward-looking
statements within the meaning of federal securities laws, including
statements regarding the potential applications, benefits and
advantages of Guardant Health’s GuardantINFORM platform as well as
its clinical-genomic dataset, 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. Such risks and uncertainties include
those discussed under the caption “Risk Factors” in Guardant
Health’s Annual Report on Form 10-K for the year
ended December 31, 2019, its Quarterly Report on Form 10-Q for
the period ended March 31, 2020, and in its other reports filed
with the Securities and Exchange Commission. These
forward-looking statements are based on current expectations,
forecasts, assumptions and information available to Guardant
Health as of the date hereof, and actual outcomes and results
could differ materially from these statements due to a number of
factors, 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. Investors are urged
not to rely on any forward-looking statement in reaching any
conclusion or making any investment decision about any securities
of Guardant Health.
Investor Contact: Carrie
Mendivilinvestors@guardanthealth.com
Media Contact: Anna
Czenepress@guardanthealth.com
Becky Lauerbecky.lauer@uncappedcommunications.com
References
- Kumar N, Hanna D, Yu J, et al. Development of a
clinical-genomic database to study tumor evolution and molecular
biomarkers of drug resistance in a real-world setting. Poster
presented at: AACR Virtual Meeting II: June 22, 2020.
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