Guardant Health Announces Regulatory Approval from Singapore's Health Sciences Authority for Guardant360® CDx Blood Test

Tuesday, May 30, 2023

Guardant Health received regulatory approval from Singapore's Health Sciences Authority (HSA) for their liquid biopsy test called Guardant360® CDx. This test is designed to provide comprehensive genomic profiling (CGP) or tumour mutation profiling for patients who have advanced solid cancers.

The Guardant360 CDx test is a liquid biopsy test that provides comprehensive genomic profiling (CGP) results within approximately seven days from the receipt of a blood sample in the laboratory. This quick turnaround time allows physicians to make faster treatment decisions compared to traditional tissue biopsies, which can take longer to process and analyse.

This approval allows healthcare professionals to determine which patients may derive therapeutic benefits from treatment with TAGRISSO® (osimertinib).

Originally developed as a laboratory developed test (LDT), the Guardant360 liquid biopsy has gained extensive acceptance for its blood-based CGP approach, with over 400 peer-reviewed publications highlighting its effectiveness. This approval further solidifies the test's position as a trusted and widely adopted tool in the field of genomic profiling.

Singapore's Health Sciences Authority (HSA) has achieved a significant milestone by granting approval for comprehensive genomic profiling (CGP) of all solid tumours using Guardant360 CDx, making it the first blood test to receive such recognition.