Bruna Pellini, MD, on the Approval of the Guardant360 CDx


The liquid biopsy was approved by the FDA for comprehensive genomic profiling in patients with any solid malignant neoplasm.

The Guardant360 CDx was approved by the FDA for comprehensive genomic profiling in patients with any solid malignant neoplasm, according to Guardant Health, the developer of the liquid biopsy.

Further, the tool is also approved as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with osimertinib (Tagrisso).

“Approval of a companion diagnostic that uses a liquid biopsy and leverages next-generation sequencing marks a new era for mutation testing,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a press release.2 “In addition to benefitting from less invasive testing, patients are provided with a simultaneous mapping of multiple biomarkers of genomic alterations, rather than one biomarker at a time, which can translate to decreased wait times for starting treatment and provide insight into possible resistance mechanisms.”

The approval was based on clinical and validation data observed from more than 5000 samples. Moreover, in a retrospective analysis of data from 2 pivotal phase 3 clinical trials, FLAURA and AURA3, patients with NSCLC identified for treatment with osimertinib using the liquid biopsy demonstrated progression-free survival (PFS) rates consistent with those identified using traditional biomarker testing.

In an interview with CancerNetwork®, Bruna Pellini, MD, assistant member in the Department of Thoracic Oncology at Moffitt Cancer Center, discussed the approval of the Guardant360 CDx and what the tool offers for patients.

This segment comes from the CancerNetwork® portion of the MJH Life Sciences Medical World News, airing daily on all MJH Life Sciences channels.

1. Guardant Health Guardant360® CDx First FDA-Approved Liquid Biopsy for Comprehensive Tumor Mutation Profiling Across All Solid Cancers [news release]. Redwood City, California. Published August 7, 2020. Accessed September 17, 2020.

2. FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test [news release]. Published August 7, 2020. Accessed September 17, 2020.

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