FDA approves Guardant360 CDx to identify EGFR mutations in non-small cell lung cancer
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The FDA today approved Guardant360 CDx, a liquid biopsy companion diagnostic that uses next-generation sequencing, to identify EGFR mutations in patients with metastatic non-small cell lung cancer.
This is the first approval to combine next-generation sequencing and a liquid biopsy into one diagnostic test, according to a press release from the FDA.
“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 the press release. “In addition to benefiting 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.”
Guardant360 CDx (Guardant Health) uses next-generation sequencing to simultaneously detect mutations in 55 tumor genes instead of evaluating one gene at a time.
Although the test can provide information on multiple solid tumor biomarkers, the FDA approval applies only to identification of EGFR mutations in patients with metastatic NSCLC who may benefit from osimertinib (Tagrisso, AstraZeneca), a third-generation, irreversible EGFR-directed tyrosine kinase inhibitor. Osimertinib has been approved by the FDA for first-line treatment of patients with metastatic NSCLC whose tumors harbor EGFR mutations.
Genomic findings for other biomarkers are not validated for choosing a specific treatment for that disease based on this approval, according to the FDA.
If the specific EGFR mutations for NSCLC are not found in the blood, clinicians should perform a tumor biopsy to determine if the mutations are present.
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