Guardant Health, Inc. (NASDAQ: GH), a precision oncology company, has received certification under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746) for its Guardant360® CDx blood test. This certification, granted by TÜV SÜD Product Service, permits the test to be used for tumour mutation profiling across all solid cancerous tumours and for identifying patients who may benefit from targeted therapies for advanced non-small cell lung cancer and breast cancer.
The IVDR certification represents a significant advancement in cancer care within the EU, likely facilitating the broader use of genomic profiling in clinical practice. The Guardant360 CDx test, a next-generation sequencing-based assay, utilises circulating tumour DNA from blood samples to detect genomic alterations. This liquid biopsy offers a less invasive alternative to traditional tissue biopsies, enabling faster and potentially more accessible comprehensive genomic profiling for patients with advanced cancer.
Helmy Eltoukhy, Guardant Health chairman and co-CEO, expressed confidence that this certification would expedite the adoption of genomic profiling and support the development of new targeted therapies. Ultimately, this will increase the number of patients receiving personalised treatments.
With the IVDR certification, Guardant360 CDx can now be used in the EU as a companion diagnostic tool. It can identify patients with non-small cell lung cancer who may benefit from specific treatments, such as TAGRISSO® (osimertinib), RYBREVANT® (amivantamab), or LUMYKRAS® (sotorasib). Additionally, it can identify those with advanced breast cancer with ESR1 mutations for treatment with ORSERDU™ (elacestrant).
The importance of Guardant360 CDx is underscored by its potential impact on clinical trials and treatment matching, as well as its use by over 12,000 oncologists to date and more than 400 peer-reviewed publications. The test first received U.S. FDA approval in August 2020 and a CE mark for tumour mutation profiling in March 2021. It provides genomic results from a blood draw in seven days, covering all genes recommended by the National Comprehensive Cancer Network, including those relevant to non-small cell lung cancer treatment guidelines.
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™.
