Guardant Health’s upgraded Guardant360 Liquid CDx won FDA approval, expanding the blood-based, tumor-informed genomic/epigenomic test’s clinical reach. The new assay evaluates a 100-fold larger genomic footprint than the prior Guardant360 Liquid CDx version and transfers the seven existing companion-diagnostic indications to the updated platform. The test is intended to guide treatment decisions in advanced cancer, leveraging circulating tumor DNA (ctDNA) and epigenomics from a single blood draw. Guardant says the analytical sensitivity is severalfold higher, aiming to capture tumor signals that may be missed by genomics alone. Helmy Eltoukhy, chairman and co-CEO of Guardant, framed the approval as convergence of genomics, epigenomics, AI, and data from more than 1 million patients tested. The approval also has near-term commercial implications for Guardant’s Advanced Diagnostic Laboratory status and reimbursement dynamics.