Manufacturing and Marketing Approval Granted for Guardant360 CDx Genomic Profiling in Japan
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
On March 14, 2022, Guardant Health Japan Co., Ltd. announced that it had received manufacturing and marketing approval for Guardant360 CDx, a genomic profiling test used for genomic analysis of solid tumors.
Guardant360 CDx uses next-generation sequencing (NGS) to measure circulating tumor DNA (ctDNA) in the blood. Based on these measurements, it helps clinicians develop treatment plans for patients with solid tumors.
Unlike traditional biopsy methods that require tumor tissue, this test uses a simple blood sample. This liquid biopsy approach was approved by the U.S. Food and Drug Administration (FDA) in August 2020 for the detection of all solid tumors.
Guardant360 CDx has been approved for several specific diagnostic uses, including: identifying MSI-High solid tumor patients eligible for KEYTRUDA; diagnosing MSI-High colorectal cancer for treatment with OPDIVO; and identifying patients with KRAS G12C mutation-positive, unresectable recurrent small cell lung cancer whose disease has progressed after chemotherapy for treatment with LUMAKRAS.
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