Precision oncology company Guardant Health has received the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR 2017/746) for its Guardant360 CDx liquid biopsy test.
The certification granted by TÜV SÜD Product Service is for profiling tumour mutation in individuals with any type of solid cancerous tumour.
Additionally, it covers companion diagnostic indications to detect patients who could potentially benefit from specific targeted therapies for advanced non-small cell lung cancer and breast cancer.
Under the IVDR, Guardant360 CDx is authorised as a companion diagnostic for identifying patients with non-small cell lung cancer who might benefit from treatment with Tagrisso, Rybrevant, or Lumykras.
Additionally, it is certified for advanced breast cancer patients with ESR1 mutations who may benefit from treatment with Orserdu.
Guardant Health chairman and co-CEO Helmy Eltoukhy said: “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 advanced cancer patients who receive potentially life-changing treatments.”
Guardant360 CDx uses next-generation sequencing (NGS) technology to identify genomic alterations by analysing circulating tumour DNA derived from the blood.
The test enables clinicians to conduct tumour mutation profiling, also referred to as comprehensive genomic profiling (CGP).
Guardant360 CDx aids in developing personalised treatment decisions for patients with advanced cancer by detecting somatic mutations in solid tumours through a simple blood draw.
The blood test secured the US Food and Drug Administration (FDA) approval in August 2020 and the CE mark for tumour mutation profiling in March 2021.
In a separate development, FDA’s staff reviewers voiced apprehensions regarding Guardant Health’s Shield blood test for cancer of the colon or rectum, reported Reuters.
According to the news agency, the reviewers cautioned that the test may fail to detect certain types of tumours that can develop into cancer. However, the test can boost compliance with screening for colorectal cancer and help identify it in earlier stages, said the reviewers.
