Guardant Health said the FDA has approved its upgraded Guardant360 Liquid CDx, a blood-based liquid biopsy intended to guide treatment decisions in advanced cancer. The company said the test incorporates both genomic and epigenomic analysis from a single blood draw, with a claimed several-fold sensitivity increase for circulating tumor DNA. Guardant’s new assay expands the genomic footprint 100-fold compared with previously approved Guardant360 CDx tests, while transferring the seven existing FDA-labeled companion-test indications to the upgraded version. Those indications include CDx use across therapies in non-small cell lung cancer, colorectal cancer and targeted therapy in advanced breast cancer for ESR1 mutations, per the company. Analysts highlighted potential commercial upside tied to earlier listing as an Advanced Diagnostic Laboratory Test and higher average sales pricing. Guardant’s stock rose in early trading following the announcement.
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