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GRAIL Announces Strategic Collaboration With AstraZeneca to Develop Companion Diagnostic Tests to Enable the Treatment of Early-Stage Cancer

Collaboration Will Leverage GRAIL’s Proprietary Methylation Platform to Identify Patients Across Multiple Tumor Types in Early Stages of Disease Who Could Benefit From Novel Therapy

GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, announced a broad strategic collaboration with AstraZeneca to develop and commercialize companion diagnostic (CDx) assays for use with AstraZeneca’s therapies. The collaboration will initially focus on developing companion diagnostic tests to identify patients with high-risk, early-stage disease, with plans to embark on numerous studies across multiple indications over the next several years. The parties are additionally planning to use GRAIL’s technology to enable recruitment of patients with early-stage cancer for AstraZeneca’s clinical studies.

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“We are excited to embark on this work with AstraZeneca to transform cancer outcomes through a broad, strategic collaboration,” said Sir Harpal Kumar, President, Biopharma Business and Europe at GRAIL.

“GRAIL has developed a novel approach to detect cancer signals in blood, regardless of whether or not the patient has clinical symptoms. We are excited to embark on this work with AstraZeneca to transform cancer outcomes through a broad, strategic collaboration,” said Sir Harpal Kumar, President, Biopharma Business and Europe at GRAIL. “Through our collaboration, we hope to provide critical information to improve the identification of patients who may be eligible for clinical trials and change clinical paradigms for the treatment of early-stage cancers.”

Across the projects within this collaboration, GRAIL will use its methylation platform to perform testing for patients enrolled in AstraZeneca’s clinical trials. GRAIL will seek regulatory approval in key markets for the liquid biopsy companion diagnostics.

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Susan Galbraith, Executive Vice President of Oncology R&D, AstraZeneca, said: “Identifying and treating cancer early is at the heart of this strategic collaboration. Combining GRAIL’s innovative blood-based methylation profiling platform with AstraZeneca’s leadership in Oncology, we hope to accelerate the adoption of circulating tumor DNA across clinical trials and make our cancer medicines available at an earlier stage of disease when there is greater potential to transform patient outcomes, and even cure.”

GRAIL is developing its proprietary methylation platform for use in multiple post-diagnostic settings to identify patients at high risk of future cancer recurrence, detect the presence or absence of residual disease, and to inform treatment decisions, including identifying patients with cancer who may be eligible for neoadjuvant or adjuvant therapy. GRAIL’s technology platform is designed to optimize circulating tumor DNA testing to enable detection of early stage disease and minimal residual disease (MRD).

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