Guardant Health Receives Regulatory Approval from Singapore’s Health Sciences Authority for Guardant360® CDx blood test for patients with advanced solid cancers
May 30, 2023
SINGAPORE — Guardant Health, Inc. (Nasdaq: GH) announced today that Singapore’s Health Sciences Authority (HSA) has granted regulatory approval of Guardant360® CDx, a liquid biopsy test for tumor 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 tumors. 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.
“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,” said Simranjit Singh, CEO of Guardant Health AMEA. “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.”
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.1 According to the Singapore Cancer Registry Annual Report 2020, over 70% of all lung cancer cases among men and women were diagnosed at the advanced stage.2 Pancreatic, stomach and colorectal cancer cases among men and women were also diagnosed at the advanced stage respectively (71.9%, 62.1%, 58.3%).2 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.
The Guardant360 CDx test was the first blood test to be approved by the U.S. Food and Drug Administration (FDA) for comprehensive genomic profiling for all solid tumors, and it is now FDA approved as a companion diagnostic test for four targeted therapies in NSCLC and one in advanced breast cancer. In March 2022, the test was also granted regulatory approval by Japan’s Ministry of Health, Labour and Welfare for tumor mutation profiling in patients with advanced solid cancers as well as a companion diagnostic to identify patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda® (pembrolizumab) and patients with MSI-High advanced colorectal cancer who may benefit from Opdivo® (nivolumab). In addition, Guardant Health is currently involved in multiple studies with drug development companies to develop Guardant360 CDx as a companion diagnostic for new therapies.