FDA approves Guardant's liquid biopsy NGS test

2016 09 02 09 36 05 93 Fda Logo V2 400

The U.S. Food and Drug Administration (FDA) has approved the first liquid biopsy companion diagnostic (CDx) that also uses next-generation sequencing (NGS) to identify patients with specific types of EGFR mutations in a form of metastatic non-small cell lung cancer (NSCLC).

Guardant Health's Guardant360 CDx assay uses a blood sample to provide healthcare professionals with genetic information about the patient's tumor and also large-panel genetic sequencing, known as high-throughput tumor profiling, to detect mutations in 55 tumor genes, rather than one gene at a time.

Patients are provided with a simultaneous mapping of multiple biomarkers of genomic alterations, rather than one biomarker at a time, which can translate to faster treatment and more insight into possible resistance mechanisms, the FDA said in a release.

The FDA's approval is specific to the test's use in identifying EGFR mutations in patients who will benefit from treatment with Tagrisso (osimertinib), an FDA-approved therapy for a form of metastatic NSCLC. If the specific NSCLC mutations associated with the FDA's approval are not detected in the blood, a tumor biopsy should be performed to determine if the NSCLC mutations are present, the agency said.

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