FDA Approves Guardant360 CDx for Comprehensive Genomic Profiling in All Solid Cancers

August 10, 2020

The FDA approved Guardant360 CDx, the first liquid biopsy companion diagnostic that also uses next-generation sequencing technology to identify patients with any solid malignant neoplasm.

The FDA has approved Guardant360 CDx for comprehensive genomic profiling in patients with any solid malignant neoplasm, according to Guardant Health, the developer of the liquid biopsy.1

The Guardant360 CDx 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). Notably, this is the first approval to combine both next-generation sequencing (NGS) and liquid biopsy technology in 1 diagnostic test in order to guide treatment decisions.

“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 of the Guardant360 CDx 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.

“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,” Helmy Eltoukhy, Guardant Health CEO, said in the 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.”

“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,” Eltoukhy continued.

According to Guardant, the Guardant360 liquid biopsy laboratory developed test has become widely accepted for blood-based comprehensive genomic profiling, with over 150 peer-reviewed publications since it was first introduced. Further, it has been used by more than 7000 oncologists nationwide, and more than 150,000 Guardant360 tests have been performed to date. Importantly, the company also indicated that the test is broadly covered by Medicare and many private payers.

Reference:

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 August 10, 2020. https://investors.guardanthealth.com/news-releases/news-release-details/guardant-health-guardant360r-cdx-first-fda-approved-liquid.

2. FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test [news release]. Published August 7, 2020. Accessed August 10, 2020.