Guardant Health has received regulatory approval from Singapore’s Health Sciences Authority (HSA) for its Guardant360 CDx test to identify patients with cancers.
Guardant360 CDx is a liquid biopsy test intended for tumour mutation profiling, also known as comprehensive genomic profiling (CGP) in patients with advanced solid cancers.
In addition, the test is approved as a companion diagnostic (CDx) to identify patients with advanced non-small cell lung cancer (NSCLC) with alterations in epidermal growth factor receptor (EGFR), who are eligible for treatment with Tagrisso (osimertinib).
Tagrisso is a third-generation, irreversible EGFR-TKI offered by AstraZeneca, which showed clinical activity in NSCLC, including against central nervous system metastases.
The Guardant360 CDx is the first blood test to be approved in Singapore, for comprehensive genomic profiling for all solid tumours, said the US-based precision oncology company.
Guardant Health AMEA CEO Simranjit Singh said: “We are delighted to receive regulatory approval from HSA for our Guardant360 CDx test, as it supports the value liquid biopsy brings to oncologists and the patients they treat.
“With a simple blood draw from the patient, the Guardant360 CDx test provides CGP results in approximately seven days from receipt of the blood sample in the laboratory, enabling physicians to make faster treatment decisions compared to tissue biopsies.
“Our hope is that this approval will drive clinical adoption of liquid biopsy testing in Singapore and enable more patients to be matched to potentially life-changing precision medicines.”
Guardant said that more than 23,600 people in Singapore were diagnosed with cancer, resulting in over 12,000 cancer-related deaths in 2020.
More than 70% of all lung cancer cases were diagnosed at the advanced stage, followed by pancreatic, stomach and colorectal cancer cases.
Guardant Health AMEA, a wholly owned subsidiary of Guardant Health, is currently working together with Singapore’s National Cancer Centre and National University Cancer Institute, to improve cancer outcomes.
Guardant Health AMEA is conducting several clinical trials using the Guardant360 test to rapidly identify genomic biomarkers in patients with cancer.
According to the US precision oncology company, its Guardant360 CDx is the first FDA-approved blood test for comprehensive genomic profiling for all solid tumours.
In addition, the test is currently approved as a companion diagnostic test for four targeted therapies in NSCLC and one in advanced breast cancer.
Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Guardant360 CDx in March last year, for tumour mutation profiling in patients with advanced solid cancers.
The test was also approved as a CDx to identify patients with microsatellite instability-high (MSI-High) solid tumours, eligible for treatment with Keytruda (pembrolizumab) and patients with MSI-High advanced colorectal cancer, eligible for treatment with Opdivo (nivolumab).
