Guardant Health secured FDA approval for its upgraded Guardant360 Liquid CDx, expanding the test’s clinical utility with a reported 100-fold larger genomic footprint compared with the prior Guardant360 CDx version. The assay is designed to deliver both genomic and epigenomic information from a single blood draw to guide treatment decisions in patients with advanced cancer. The FDA also transferred the seven existing companion diagnostic indications from earlier versions to the new assay, preserving label coverage while increasing analytical scope. Industry read-through centers on potential earlier and broader adoption in settings where liquid biopsy throughput and sensitivity drive clinical decisioning.
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