Guardant Health Inc. (GH) on Thursday said the U.S. Food and Drug Administration approved its Guardant360 CDx liquid biopsy test as a companion diagnostic for Boehringer Ingelheim's Hernexeos, the first targeted therapy for adults with HER2-mutant advanced non-small cell lung cancer.
Guardant360 CDx analyzes circulating tumor DNA from a blood sample, to identify patients with HER2 tyrosine kinase domain activating mutations who may be eligible for treatment with Hernexeos.
Guardant Health said the approval marks the 27th companion diagnostic indication for Guardant360 CDx across multiple tumor types globally.
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