medwireNews: The US FDA has granted approval for the first liquid biopsy next-generation sequencing (NGS) assay, including as a specific companion diagnostic test for targeting use of osimertinib.
The Guardant360 CDx assay (Guardant Health, Redwood City, California, USA) assesses for mutations in 55 tumor genes, and these include mutations in EGFR that can identify non-small-cell lung cancer patients who may benefit from osimertinib therapy.
The decision “marks a new era for mutation testing”, said Tim Stenzel, from the FDA’s Center for Devices and Radiological Health, in a press release.
He explained that the application both reduces the need for invasive testing and allows for “simultaneous mapping of multiple biomarkers of genomic alterations, […] which can translate to decreased wait times for starting treatment and provide insight into possible resistance mechanisms.”
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