AZN AstraZeneca PLC

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