The US Food and Drug Administration (FDA) has approved Guardant Health’s Guardant360 CDx for tumour mutation profiling in patients with any solid malignant neoplasm (cancerous tumour).
The Guardant360 CDx is also approved as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso (osimertinib).
The liquid biopsy companion diagnostic uses next-generation sequencing (NGS) technology to detect specific types of mutations of the EGFR gene in metastatic NSCLC.
It is the first approval to combine two technologies – NGS and liquid biopsy – in one diagnostic test in order to guide treatment decisions, the US FDA noted in a statement.
FDA’s Centre for Devices and Radiological Health In Vitro Diagnostics and Radiological Health director Tim Stenzel said: “Approval of a companion diagnostic that uses a liquid biopsy and leverages next-generation sequencing marks a new era for mutation testing.
“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.”
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The test received FDA approval based on clinical and analytical validation data from over 5,000 samples. It was found that the NSCLC patients identified for treatment with Tagrisso (osimertinib) using the Guardant360 CDx showed progression-free survival rates consistent with those identified using traditional biomarker testing.
Guardant Health CEO Helmy Eltoukhy said: “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 tumour profiling, which is often invasive and has longer turnaround times, can contribute to delays in starting treatment and possibly suboptimal therapy.”
Earlier this year, Guardant Health initiated a randomised trial to investigate circulating tumour DNA-guided adjuvant therapy in stage II colon cancer in partnership with NRG Oncology.