The FDA approved Guardant Health’s upgraded Guardant360 Liquid CDx, expanding blood-based tumor profiling to a much larger genomic footprint for cancer treatment decision-making. Guardant said the new test analyzes genomic and epigenomic information from a single blood draw and covers a 100-times wider genomic footprint than the prior Guardant360 Liquid CDx. The company also stated that seven companion diagnostic indications granted for the previous test version transfer to the upgraded assay, keeping label continuity while improving sensitivity. Analysts highlighted potential downstream impacts on reimbursement timing and pricing, as the upgraded assay may be positioned sooner for Advanced Diagnostic Laboratory test status. For oncology workflows, the move continues the shift toward broader ctDNA profiling in lieu of tissue when samples are limited, while regulatory clearance extends the footprint of actionable companion-diagnostic guidance.