The Guardant360 CDx blood test has received certification from TÜV SÜD Product Service under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746) for tumour mutation profiling in patients with solid tumours. This certification also includes Guardant360 CDx as a companion diagnostic to identify patients who may benefit from specific targeted therapies for advanced non-small cell lung cancer (NSCLC) and breast cancer.
Under the current IVDR framework, most manufacturers are required to obtain a conformity assessment and certificate from an accredited company such as TÜV SÜD. The IVDR certification for Guardant360 CDx ensures its broad accessibility across the EU, aiding oncologists in identifying patients suitable for clinical trials and matching them with appropriate precision therapies to effectively target their diseases.
Guardant360 CDx is a comprehensive genomic test that delivers detailed results from a simple blood draw using ctDNA analysis within seven days; the test encompasses all genes recommended by the National Comprehensive Cancer Network. This enables clinicians to identify somatic mutations in solid tumours and offer personalised treatment options to patients with advanced cancer. Since its inception, Guardant360 CDx has been featured in over 400 peer-reviewed publications, utilised by over 12,000 oncologists, with more than 500,000 tests performed.
In August 2020, the FDA approved Guardant360 CDx for comprehensive genomic profiling in patients with any solid malignancy. Additionally, the test was approved as a companion diagnostic to detect EGFR mutations in patients with NSCLC who could potentially benefit from osimertinib. This regulatory decision marked Guardant360 CDx as the first comprehensive genomic profiling liquid biopsy test to be approved by the FDA.
The decision certifies Guardant360 CDx for use in identifying patients with NSCLC who may benefit from therapy with osimertinib (Tagrisso), amivantamab-vmjw (Rybrevant), or sotorasib (Lumakras). The certification also includes identifying patients with advanced breast cancer harbouring ESR1 mutations who could benefit from treatment with elacestrant (Orserdu).
Dr. Helmy Eltoukhy, the Chairman and Co-Chief Executive Officer of Guardant Health, stated in a news release: “The IVDR certification for the Guardant360 CDx liquid biopsy is a significant milestone for cancer care in the EU, as the test provides faster access to comprehensive genomic profiling for oncologists and, more importantly, for the patients they treat. We are confident that this certification will help accelerate wider adoption of guideline-recommended genomic profiling, pave the way for the development of new targeted therapies, and increase the number of patients with advanced cancer who receive potentially life-changing treatments.”
Dr. Peter Fasching, Professor of Obstetrics and Gynaecology and Coordinator of the Breast Cancer Center and the Gynaecological Cancer Center at the Comprehensive Cancer Center Erlangen-EMN in Germany, commented in the press release: “I am pleased that the new IVDR framework provides strict and high-quality standards for diagnostic tools, as this will contribute to a better standard of care and clinical trial protocols. Using IVDR-certified liquid biopsy more broadly will allow us to find more biomarkers that can be targeted in the future and give clinicians confidence that they are using a highly validated tool to select the optimal individualized treatment plan for the patient.”
References:
- Guardant Health receives EU IVDR certification for Guardant360 CDx liquid biopsy for tumour mutation profiling across all solid cancers and companion diagnostic indications. News release. Guardant Health, Inc. May 21, 2024. Accessed May 22, 2024.
- Guardant Health Guardant360 CDx first FDA-approved liquid biopsy for comprehensive tumour mutation profiling across all solid cancers. News release. Guardant Health, Inc. August 7, 2020. Accessed May 22, 2024.
EDX Medical Group Plc (AQSE:EDX) is a global specialist in digital clinical diagnostics; developing and supporting high-performance products and services to provide cost-effective prediction of disease risk, inform clinical decision-making, enable personalised healthcare and accelerate the development of new medicines for cancer, neurology, heart disease and infectious diseases. EDX Medical entered into a strategic agreement with Guardant Health Inc., under which they distribute Guardant360® CDx and Guardant Reveal™.
