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Guardant Health Attains IVDR Certification for Guardant360 CDx Across Solid Tumors

NextEdge Admin

22 May 2024

1 min 40 sec

comprehensive genomic profiling,companion diagnostic test,Oncology

Guardant Health announced on Tuesday the certification of its liquid biopsy comprehensive genomic profiling and companion diagnostic test, Guardant360 CDx, under the European Union’s In Vitro Diagnostic Regulation by TÜV SÜD Product Service. This certification expands the assay’s adoption for guideline-recommended testing, aiding therapy selection for advanced cancer patients. Specific companion diagnostic indications include Tagrisso, Rybrevant, Lumykras in advanced non-small cell lung cancer, and Orserdu in breast cancer.

Nicola Normanno, from IRCCS Romagna Institute for the Study of Tumors, noted that targeted therapy adoption in the EU lags behind guidelines due to insufficient tissue samples for molecular profiling. The expanded availability of liquid biopsy testing is expected to address this gap.

Guardant co-CEO Helmy Eltoukhy expressed confidence in the certification’s potential to accelerate wider adoption of genomic profiling, facilitate new targeted therapy development, and increase access to life-changing treatments for advanced cancer patients.

Since its introduction, Guardant360 has been utilized by over 12,000 oncologists, with more than 500,000 tests conducted to date, marking significant strides in precision oncology.