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Liquid Biopsy Companion Diagnostic Test Approved for Metastatic NSCLC

By: Jocelyn Solis-Moreira, MS
Posted: Thursday, August 27, 2020

The U.S. Food and Drug Administration (FDA) recently approved Guardant360 CDx Assay, a liquid biopsy companion diagnostic with next-generation sequencing technology, to be used to identify eligible patients for treatment with the FDA-approved drug osimertinib. The companion diagnostic will detect specific EGFR mutations in patients with nonsmall cell lung cancer (NSCLC).  

The test is the first to combine next-generation sequencing technology and liquid biopsy with the goal of providing more information on multiple solid tumor biomarkers to better guide treatment decisions. Liquid biopsy collects blood samples from patients to determine genetic information about a patient’s tumor. Next-generation sequencing technology uses high-throughput tumor profiling to better evaluate tumor composition, helping providers to evaluate problematic mutations. The next-generation sequencing technology allows the companion diagnostic to simultaneously detect mutations in 55 tumor genes, rather than gene at a time. 

In addition, on August 26, the FDA approved the FoundationOne®Liquid CDx companion diagnostic for three  EGFR tyrosine kinase inhibitors in the first-line setting for NSCLC. 



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