USA – Guardant Health, a leading precision oncology company in the US, has secured regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for Guardant360 CDx.
Guardant360 CDx is a liquid biopsy test for tumor mutation profiling in patients with advanced solid tumors.
Guardant360 CDx was also approved by the Japanese health ministry as a companion diagnostic to detect patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda (pembrolizumab) and those with MSI-High advanced colorectal cancer (CRC) who may benefit from Opdivo (nivolumab).
The liquid biopsy test was approved by the health ministry in December to be used as a companion diagnostic for detecting patients with metastatic non-small cell lung cancer (NSCLC) who may benefit from Lumakras (sotorasib) treatment.
This regulatory approval has taken on an added significance as CRC is the most commonly diagnosed cancer in Japan.
Guardant360 CDx is made available by Guardant Health Japan, a precision oncology company based in Tokyo and a wholly owned subsidiary of Guardant Health Asia, Middle East, and Africa (AMEA).
Guardant Health co-CEO Helmy Eltoukhy said: “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.
“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.”
Guardant360 CDx analyzes circulating tumor DNA (ctDNA) from blood samples of patients with advanced solid tumors to detect genetic changes that may inform treatment decisions.
Guardant360 CDx was approved by the US Food and Drug Administration (FDA) in August 2020 for comprehensive genomic profiling across all solid cancers.
As a companion diagnostic, it detects non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) alterations who may benefit from Tagrisso therapy (osimertinib).
This is the first FDA-approved liquid biopsy test for comprehensive tumor mutation profiling across all solid cancers.
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