FDA Approves First NGS-Based Liquid Biopsy Companion Diagnostic

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On Friday, the U.S. Food and Drug Administration (FDA) approved the first next-generation sequencing-based (NGS) liquid biopsy companion diagnostic (CDx) to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a form of metastatic non-small cell lung cancer (NSCLC). The approval of Guardant360 CDx is the first to combine both NGS and liquid biopsy in a single diagnostic test.

“Approval of a companion diagnostic that uses a liquid biopsy and leverages next-generation sequencing marks a new era for mutation testing,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health in a press release. “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 FDA has approved Guardant360 CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid cancerous tumor and has also approved it as a companion diagnostic to identify non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso (osimertinib). While many patients are expected to benefit from the non-invasive testing provided by the approved liquid biopsy, the FDA noted that if the specific NSCLC mutations associated with the CDx approval are not detected in the blood, then a tumor biopsy should be performed to determine if the NSCLC mutations are present.

“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. 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 applaud the FDA for their collaborative review process and for approving the first comprehensive genomic profiling liquid biopsy test,” said Helmy Eltoukhy, Guardant Health CEO in a company press release. “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.”

The Guardant360 CDx assay was previously granted a Breakthrough Device designation, in which the FDA provides intensive interaction and guidance to the company on efficient device development.

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