Business
Guardant Health Receives Regulatory Approval from Singapore's Health Sciences Authority for Guardant360® CDx blood test for patients with advanced solid cancers
Guardant360® CDx is a comprehensive genomic profiling blood test that provides critical information to help inform personalized treatment decisions for
About this update from Guardant Health, Inc.
[{"type":"text","content":"Guardant360® CDx is a comprehensive genomic profiling blood test that provides critical information to help inform personalized treatment decisions for patients with advanced solid cancers The liquid biopsy test is also approved as a companion diagnostic for TAGRISSO® (osimertinib) in non-small cell lung cancer This is the first blood test to be approved by Singapore's Health Sciences Authority for comprehensive genomic profiling for all solid tumors SINGAPORE, May 29, 2023 /PRNewswire/ -- 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). \n\n \n \n \n \n \n \n\n \nGuardant360 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.\n\"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.\"\nIn 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 R...