NEW YORK (GenomeWeb) – Guardant Health announced today a multiyear agreement with AstraZeneca to develop blood-based companion diagnostic tests for drugs in the pharma firm's oncology portfolio.
Under the terms of the agreement, Guardant is developing and pursuing FDA approval for a companion test that will help identify non-small cell lung cancer patients likely to respond to Tagrisso (osimertinib), AstraZeneca’s third-generation EGFR inhibitor.
Currently, Roche's Cobas EGFR Mutation Test v2 is the only approved liquid biopsy companion test to Tagrisso.
Guardant will also develop a plasma-based tumor mutational burden (TMB) test using its broader GuardantOmni panel to predict response to AstraZeneca immunotherapy drugs including Imfinzi (durvalumab).
The agreement also provides for the potential development of further CDx for other therapies in AstraZeneca’s clinical development programs, both targeted and immune-focused.
According to Guardant, the US Food and Drug Administration has granted breakthrough designation to GuardantOmni diagnostic device for its proprietary plasma-based TMB score.
AstraZeneca presented TMB data from its use of GuardantOMNI in its Phase III MYSTIC trial at the European Society for Medical Oncology (ESMO) Immuno-Oncology 2018 Congress today.
"The data presented today … 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," Guardant Health Cofounder and COO AmirAli Talasaz said in a statement.