Precision oncology firm Guardant Health has entered into a multi-year agreement with AstraZeneca to develop companion diagnostic (CDx) tests for the pharmaceutical company’s oncology products.
Under the deal, the companies will develop blood-based CDx tests to support the commercialization of AstraZeneca’s oncology portfolio based on Guardant’s liquid biopsy platform.
AstraZeneca Innovative Medicines and Early Development (IMED) biotech unit’s precision medicine and genomics senior vice president Dr Ruth March said: “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.”
As per terms of the deal, Guardant Health will develop and secure approval from the US Food and Drug Administration (FDA) for a Guardant360 CDx test for Tagrisso (osimertinib), which is AstraZeneca’s third-generation EGFR inhibitor for advanced non small cell lung cancer (NSCLC).
Guardant360 CDx assay will help identify patients responding to Tagrisso through minimally-invasive blood test.
Guardant Health will also engage in the development of a plasma-based tumor mutational burden (TMB) score CDx test through using GuardantOMNI to anticipate response to AstraZeneca immunotherapy and targeted therapies within its oncology portfolio.
AstraZenec has already revealed the TMB data using GuardantOM device from the phase III Mystic trial.
Guardant Health secured breakthrough designation from the FDA for GuardantOMNI diagnostic device for itsplasma-based TMB score.
The Guardant TMB scoring methodology has been advanced to be used for plasma-based testing, as well as maximize sensitivity and specificity. It was optimized by considering various factors such as tumor shedding.
In addition, the deal will enable to further develop liquid biopsy CDx tests for AstraZeneca’s other clinical development programs.
Guardant Health co-founder and COO AmirAli Talasaz said: “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.”
Guardant Health provides multiple liquid biopsy-based tests for advanced stage cancer patients. Its Guardant360 has been used by over 5,000 oncologists, more than 40 biopharmaceutical firms and 27 of the National Comprehensive Cancer Network centers since its launch in 2014.