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FDA Approves Guardant’s Guardant360 CDX Comprehensive Genomic Profile

 
• By Reed Miller

The liquid-biopsy test is also a companion diagnostic for osimertinib, AstraZeneca’s drug for non-small cell lung cancer.

test-tube-DNA
• Source: shutterstock.com

The US Food and Drug Administration approved Guardant Health, Inc.’s Guardant360 CDx comprehensive genomic profiling test for patients with any solid malignant tumor, the company announced on 7 August.

The FDA also approved it as a companion diagnostic to identify non-small cell lung cancer patients with epidermal growth factor receptor alterations who may benefit from AstraZeneca PLC’s drug osimertinib, an epidermal growth factor receptor tyrosine kinase inhibitor marketed as Tagrisso

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