Guardant Health received FDA approval for its upgraded Guardant360 Liquid CDx test, providing broader genomic and epigenomic profiling from a single blood draw. The company said the test covers a 100-times wider genomic footprint than the previously approved Guardant360 CDx version, intended to improve sensitivity for circulating tumor DNA and deliver additional insights missed by genomics alone. The FDA approval transfers the seven previously approved companion diagnostic indications from the earlier test to the new upgraded assay. These uses include liquid biopsy CDx roles across non-small cell lung cancer and colorectal cancer and a targeted therapy CDx in advanced breast cancer for ESR1 mutations. Guardant framed the update as part of a shift toward using genomics and epigenomics for more actionable treatment guidance from blood-based testing. In the market reaction, analysts pointed to potential changes in pricing and listing pathways, including earlier Advanced Diagnostic Laboratory Test categorization. For clinicians and payers, the decision expands the available toolset for tumor profiling in advanced cancers, with label portability reducing the burden of switching between assay versions.
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