On March 14, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of Guardant360 CDx, a liquid biopsy test for tumor mutation profiling, also known as comprehensive genomic profiling, in patients with advanced solid tumors (Press release, Guardant Health, MAR 14, 2022, View Source [SID1234610052]).
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MHLW also approved Guardant360 CDx as a companion diagnostic to identify patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda (pembrolizumab) and patients with MSI-High advanced colorectal cancer (CRC) who may benefit from Opdivo (nivolumab). In December 2021, MHLW granted regulatory approval of Guardant360 CDx as a companion diagnostic for identifying patients with metastatic non-small cell lung cancer (NSCLC) who may benefit from treatment with LUMAKRAS (sotorasib).
"The MHLW approval of Guardant360 CDx marks a significant milestone for Guardant Health and further reinforces the value blood-based testing brings to physicians and patients with advanced cancer. With a simple blood draw, a physician can conduct comprehensive genomic profiling of a patient’s tumor, then match that patient with the best available treatment option without the complications and delays of a tissue biopsy," said Helmy Eltoukhy, Guardant Health co-CEO. "Today’s approval further strengthens Guardant Health’s global commitment to transform cancer care by bringing innovative blood-based tests like Guardant360 CDx to physicians and advanced cancer patients in Japan."
About Guardant360 CDx
Guardant360 CDx is a liquid biopsy test that analyzes circulating tumor DNA (ctDNA) from the blood samples of patients with advanced solid tumors and identifies genetic alterations that may inform treatment decisions. On August 7, 2020, the U.S. Food and Drug Administration (FDA) approved the Guardant360 CDx for comprehensive genomic profiling across all solid cancers and as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso (osimertinib). This approval represented the first FDA-approved liquid biopsy test for comprehensive tumor mutation profiling across all solid cancers.