Guardant Health Partners with AstraZeneca to Develop Blood-Based Companion Diagnostic Tests for Tagrisso and Imfinzi
December 13 2018 - 12:15PM
FDA grants breakthrough device designation to
GuardantOMNI test usedfor plasma-based tumor mutational burden
analysis in AstraZeneca trial
Guardant Health (Nasdaq: GH) announced a multi-year agreement with
AstraZeneca (NYSE: AZN) to develop blood-based companion diagnostic
(CDx) tests supporting the commercialization of AstraZeneca’s
oncology portfolio based on Guardant’s industry-leading
comprehensive liquid biopsy platform.
Under the terms of the agreement, Guardant Health will develop
and pursue FDA approval for a Guardant360® CDx test for Tagrisso®
(osimertinib), AstraZeneca’s best-in-class, third-generation EGFR
inhibitor in advanced non small cell lung cancer (NSCLC). Use of
this assay will help identify patients that may respond to Tagrisso
via a minimally-invasive blood test.
Guardant Health will also develop a plasma-based tumor
mutational burden (TMB) score CDx test using GuardantOMNI™ to
predict response to AstraZeneca immunotherapy and targeted
therapies within its oncology portfolio. AstraZeneca today
presented TMB data using this device from the Phase III MYSTIC
trial at the European Society for Medical Oncology (ESMO)
Immuno-Oncology 2018 Congress. The US Food and Drug Administration
has granted breakthrough designation to the GuardantOMNI diagnostic
device for its proprietary plasma-based TMB score. The Guardant TMB
scoring methodology is optimized for plasma-based testing by
accounting for several factors, including tumor shedding, to
maximize sensitivity and specificity.
The agreement allows for development of further liquid biopsy
CDx tests for AstraZeneca’s other clinical development
programs.
“Precision medicine is at the heart of our ambition to eliminate
cancer as a cause of death,” said Ruth March, PhD, Senior Vice
President of Precision Medicine and Genomics for AstraZeneca’s
Innovative Medicines and Early Development (IMED) Biotech Unit. “We
are committed to matching life-changing medicines to patients most
likely to benefit, and we believe our partnership with Guardant
Health will help us achieve this.”
“AstraZeneca’s work in targeted therapy and immuno-oncology has
already benefited thousands of advanced cancer patients,” said
Guardant Health Co-Founder and COO AmirAli Talasaz, PhD. “The data
presented today at ESMO’s IO congress builds on other recent data
that show Guardant’s liquid biopsy technology can increase the
number of patients who are tested for important biomarkers relative
to tissue. We are proud to support these programs using the
Guardant platform and help more patients access these important
treatments.”
Since its introduction in 2014, the Guardant360 assay has been
ordered more than 70,000 times to help inform which therapy may be
effective for advanced-stage cancer patients with solid tumors.
More than 80 peer-reviewed studies have been published addressing
its analytical validity, clinical validity, and clinical utility in
multiple tumor types. For advanced NSCLC, Guardant360 is covered by
Medicare and by several private payers, including Cigna and several
Blue Cross Blue Shield plans. It was granted breakthrough device
status by the FDA in February 2018, making it the first
comprehensive liquid biopsy to receive a breakthrough device
designation.
The GuardantOMNI assay applies the industry-leading performance
of Guardant360 to a much broader genomic footprint. The test covers
biomarkers of interest across the oncology drug development
pipeline, including biomarkers for immuno-oncology applications
such as its proprietary TMB score.
About Guardant HealthGuardant 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. Its Guardant Health
Oncology Platform is designed to leverage its capabilities in
technology, clinical development, regulatory and reimbursement to
drive commercial adoption, improve patient clinical outcomes and
lower healthcare costs. In pursuit of its goal to manage
cancer across all stages of the disease, Guardant Health has
launched multiple liquid biopsy-based tests, Guardant360 and
GuardantOMNI, for advanced stage cancer patients, which fuel its
LUNAR development programs for recurrence and early
detection. Since its launch in 2014, Guardant360 has been
used by more than 5,000 oncologists, over 40 biopharmaceutical
companies and all 27 of the National Comprehensive Cancer Network
centers.
Investor Contact:Lynn Lewis or Carrie
Mendivilinvestors@guardanthealth.com
Media:Josh Wein or Ian
Stonepress@guardanthealth.com
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