US-based Guardant Health has secured regulatory approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for Guardant360 CDx, a liquid biopsy test for tumour mutation profiling in patients with advanced solid tumours.
The Japanese health ministry also gave approval to Guardant360 CDx as a companion diagnostic to detect patients with microsatellite instability-high (MSI-High) solid tumours who may stand to benefit from Keytruda (pembrolizumab) and also those with MSI-High advanced colorectal cancer (CRC) who may be benefitted from Opdivo (nivolumab).
Last December, the health ministry gave regulatory approval to the liquid biopsy test 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.
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 tumour, 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 analyses circulating tumour DNA (ctDNA) from the blood samples of patients with advanced solid tumours and detects genetic changes that may inform decisions on treatments.
In August 2020, the US Food and Drug Administration (FDA) gave approval to Guardant360 CDx for thorough genomic profiling across all solid cancers and as a companion diagnostic to detect non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) alterations who may stand to benefit from therapy with Tagrisso (osimertinib).
This approval marks the first FDA-approved liquid biopsy test for thorough tumour mutation profiling across all solid cancers.
