FDA has approved Guardant Health’s upgraded Guardant360 Liquid CDx, extending the same companion-diagnostic indications from the earlier test to a broader genomic footprint. The new blood-based assay is positioned to improve sensitivity for circulating tumor DNA (ctDNA) and provide additional epigenomic context to guide treatment selection in advanced cancer. Guardant said the updated test analyzes a 100-fold larger genomic footprint than the previously approved Guardant360 CDx. Helmy Eltoukhy, chairman and co-CEO of Guardant, framed the approval as a step toward a more comprehensive “actionable view” from a single blood draw. For adoption, Guardant also suggested the approval could support an earlier Advanced Diagnostic Laboratory Tests (ADLT) listing timeline, with analysts pointing to potential pricing implications that could strengthen the company’s diagnostics revenues.
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