Tag Archives: Guardant Health

Aug. 23, 2022–Guardant Health announced that the FDA has approved its Guardant360 CDx liquid biopsy test as a companion diagnostic to select patients with unresectable or metastatic HER2 (ERBB2)-mutant non-small cell lung cancer whose tumors have activating HER2 mutations (single nucleotide variants and exon 20 insertions) for treatment with Enhertu

December 2020—The FDA approved the Guardant360 CDx assay (Guardant Health), a liquid biopsy companion diagnostic that also uses next-generation sequencing technology to identify patients with specific types of mutations of the epidermal growth factor receptor gene in a deadly form of metastatic non-small cell lung cancer. This is the first approval to combine NGS and liquid biopsy in one diagnostic test in order to guide treatment decisions.

Oct. 1, 2020—The FDA approved the Guardant360 CDx assay (Guardant Health), a liquid biopsy companion diagnostic that also uses next-generation sequencing technology to identify patients with specific types of mutations of the epidermal growth factor receptor gene in a deadly form of metastatic non-small cell lung cancer.

February 2019—The Lunar assay, a new blood-based assay intended to detect early-stage cancer and recurrence of disease, is available from Guardant Health for research use by biopharmaceutical and academic researchers.

December 2018—A prospective study in patients with advanced non-small cell lung cancer has demonstrated that the blood-based Guardant360 assay, developed by Guardant Health, identified clinically actionable mutations in nearly twice as many patients as tissue biopsy alone.