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Guardant Health Announces Collaboration With AstraZeneca to Develop Companion Diagnostic to Identify Patients With ESR1-mutated Metastatic Breast Cancer

Excerpt from the Press Release:

Collaboration employing Guardant360 CDx assay is first to use ctDNA comprehensive genomic profiling blood test for early detection of resistance due to ESR1 mutation prior to first-line therapy progression

PALO ALTO, Calif.–(BUSINESS WIRE)–Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today it has entered into a collaboration with AstraZeneca to pursue the development, regulatory approval and commercialization of the Guardant360® CDx blood test as a companion diagnostic to identify patients with ESR1-mutated metastatic breast cancer. The initiative is part of a larger strategic collaboration investigating the use of liquid biopsy as a tool to inform early therapy intervention.

The collaboration is one of the first to explore the potential of a comprehensive genomic profiling ctDNA (circulating tumor DNA) assay to identify mutation-driven resistance to a prior line of therapy in metastatic breast cancer. The Guardant360 CDx liquid biopsy test is being used to identify patients with detectable ESR1mutations in the SERENA-6 phase III clinical trial, which is evaluating camizestrant, a next-generation oral selective estrogen receptor degrader (ngSERD) being developed by AstraZeneca, in combination with CDK4/6 inhibitors versus aromatase inhibitors in combination with CDK4/6 inhibitors in patients with HR-positive, HER2-negative metastatic breast cancer.

“We’re pleased to collaborate with AstraZeneca on this important study for breast cancer patients,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “We look forward to exploring the potential benefit of early comprehensive genomic profiling using a simple blood draw, which can provide faster results than a tissue biopsy and enable clinicians to consider earlier intervention with the goal of achieving improved patient outcomes.”

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