Medical Device Network

Guardant’s tumour mutation profiling test gains EU IVDR certification

Guardant Health’s liquid biopsy was the first FDA-approved blood test for genomic testing of solid tumours.

Guardant Health has received the green light to market its tumour mutation profiling blood test in the European Union (EU).

Certified under the EU’s In Vitro Diagnostic Regulation (IVDR) from notified body TÜV SÜD Product Service, the test – named Guardant360 CDx – is for use in patients with any solid cancerous tumour who need their mutation profile.

The test is also indicated for use as a companion diagnostic to identify patients who may benefit from targeted therapies for non-small cell lung cancer (NSCLC) and breast cancer. This includes Tagrisso (osimertinib), Rybrevant (amivantamab), or Lumykras (sotorasib) for NSCLC patients, as well as Orserdu (elacestrant) for advanced breast cancer patients with ESR1 mutation.

Guardant received US Food and Drug Administration (FDA) approval in 2020 and CE marking under the previous IVD Directive (IVDD) for tumour mutation profiling in 2021. Guardant Health’s liquid biopsy was the first to genetically profile tumours anywhere in the body from a single blood draw.

The company said that the test now “meets requirements under stricter EU In Vitro Diagnostic Regulation”.

Guardant’s blood test is a next-generation sequencing (NGS)-based assay that uses circulating tumour DNA to detect genomic alterations. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network. Tests that profile tumours are important as looking at specific mutations in solid tumours can help inform personalised treatment options for patients at an advanced stage of cancer.

Guardant Health’s co-CEO Helmy Eltoukhy said that the certification will help expand the test’s uptake and applications.

Eltoukhy said: “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.”

The liquid biopsy market is projected to reach $6.8bn by 2028 with a compound annual growth rate of 20.9%, according to analysis by GlobalData. Much of Guardant’s competition comes from FoundationOne’s, Liquid CDx diagnostic.

The space is seeing transformation with the application of technology such as AI. Exai Bio has emerged with its RNA and AI-based liquid biopsy platform while Microsoft and Cyted have co-developed their own tools to boost oesophageal cancer detection.