FDA Approves First Comprehensive Genomic Profiling Liquid Biopsy Test for All Solid Cancers

The liquid biopsy test was also approved as a companion diagnostic test to uncover EGFR mutations in patients with NSCLC who could benefit from treatment with Tagrisso.

The Food and Drug Administration (FDA) on Friday approved Guardant360 CDx for comprehensive genomic profiling in patients with any solid cancerous tumor, according to the liquid biopsy test’s manufacturer, Guardant Health.

Guardant360 CDx was also approved as a companion diagnostic test to uncover EGFR mutations in patients with non—small cell lung cancer (NSCLC) who could benefit from treatment with Tagrisso (osimertinib).

“The FDA approval of Guardant360 CDx is a landmark decision, demonstrating the value liquid biopsy delivers to oncologists and more importantly, the patients they treat,” said Guardant Health’s CEO Helmy Eltoukhy, in a company-issued press release. “Traditional tissue biopsy-based tumor profiling, which is often invasive and has longer turnaround times, can contribute to delays in starting treatment and possibly suboptimal therapy.”

The agency based its decision on data from more than 5,000 samples, which validated the liquid biopsy test. Additionally, the release states, that data from two phase 3 trials (FLAURA and AURA3) showed that patients with NSCLC who were identified as eligible for Tagrisso therapy using Guardant360 CDx demonstrated similar progression-free survival rates to what has been identified in previous traditional biomarker testing.

“We applaud the FDA for their collaborative review process and for approving the first comprehensive genomic profiling liquid biopsy test,” said Eltoukhy. “We are confident that our FDA approval will help accelerate wider adoption of guideline-recommended genomic profiling, increase the number of advanced cancer patients who receive potentially life-changing treatments, and pave the way for new companion diagnostic developments for the Guardant360 CDx.”