30 May 2023 | News
This is the first blood test to be approved by Singapore's Health Sciences Authority for comprehensive genomic profiling for all solid tumours
US-based Guardant Health, Inc. has announced that Singapore's Health Sciences Authority (HSA) has granted regulatory approval of Guardant360 CDx, a liquid biopsy test for tumour mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with advanced solid cancers.
The Guardant360 CDx test was also approved as a companion diagnostic to identify patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with TAGRISSO (osimertinib).
Guardant360 CDx is the first blood test to be approved by Singapore's HSA for comprehensive genomic profiling for all solid tumours. Since being introduced as a laboratory developed test (LDT), the Guardant360 liquid biopsy has become widely accepted for blood-based CGP with more than 400 peer-reviewed publications.
In 2020, over 23,600 people in Singapore were diagnosed with cancer and there were slightly over 12,000 cancer-related deaths. The most prevalent cancer types among men and women in Singapore include breast (15.5%), colorectal (15.1%) and lung (12.3%) cancer.
To improve cancer outcomes in Singapore, Guardant Health AMEA is currently collaborating with National Cancer Centre Singapore and National University Cancer Institute, Singapore for several clinical trials using the Guardant360 test in efforts to accelerate clinical trial enrollment by identifying genomic biomarkers in patients with cancer.