Guardant Health Asia, Middle East & Africa (AMEA) affiliate Guardant Health Japan has submitted an application to the Ministry of Health, Labour and Welfare (MHLW), seeking regulatory approval for a liquid biopsy test for tumour mutation profiling.
Guardant360 CDx is comprehensive genomic profiling (CGP) test, which uses blood samples from patients with advanced cancerous tumours.
Guardant Health AMEA CEO and Guardant Health Japan representative director Simranjit Singh said: “I am delighted to announce that we have submitted the regulatory application for Guardant360 CDx liquid biopsy test for approval by MHLW.
“Several clinical studies have shown that compared to invasive tissue-based testing, Guardant360 has a quicker turnaround time for reporting comprehensive genomic test results.
“For the patient, this means a shorter waiting time to get the most appropriate treatment while avoiding safety risks related to tissue biopsies.”
The test evaluates circulating tumour DNA (ctDNA) from the blood samples of advanced solid tumour patients and detects genetic alterations that could aid in treatment decisions.
Guardant Health has also filed an application for Companion Diagnostic (CDx) approval of Guardant360 CDx.
Last August, the US Food and Drug Administration (FDA) approved the Guardant360 CDx for comprehensive genomic profiling across all solid cancers.
It was also approved as a companion diagnostic for detecting non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) alterations who may benefit from Tagrisso (osimertinib) treatment.
Guardant Health Japan noted that it is the first FDA-approved liquid biopsy test for complete tumour mutation profiling across all solid cancers.
The company intends to contribute to precision oncology in the country by supporting research and development efforts and drive broad clinical adoption of its products.