Guardant Health to Develop Blood-Based Diagnostic Tests for AstraZeneca's Tagrisso

Guardant Health signed a multi-year agreement with AstraZeneca to develop blood-based companion diagnostic (CDx) tests supporting the commercialization of AstraZeneca’s oncology portfolio based on Guardant’s 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 third-generation epidermal growth factor receptor (EGFR) inhibitor in advanced non-small cell lung cancer (NSCLC). Use of the assay will help identify patients that may respond to Tagrisso via a minimally invasive blood test.

Guardant Health also will 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 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 U.S. 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, Ph.D., senior vicep resident of precision medicine and genomics for AstraZeneca’s Innovative Medicines and Early Development (IMED) biotech unit.

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 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.

(Source: Guardant Health)