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Guardant Health Receives IVDR Certification for Guardant360 CDx Across Solid Tumors

NEW YORK – Guardant Health said Tuesday that it has received certification for its liquid biopsy comprehensive genomic profiling and companion diagnostic test, Guardant360 CDx, under the European Union’s In Vitro Diagnostic Regulation.

The certification, from TÜV SÜD Product Service, allows for broader adoption of the assay for guideline-recommended testing to inform optimal therapy selection for patients with advanced cancer. It includes specific companion diagnostic indications for the targeted therapies Tagrisso (osimertinib), Rybrevant (amivantamab), and Lumykras (sotorasib) in advanced non-small cell lung cancer, as well as for Orserdu (elacestrant) in breast cancer.

According to Nicola Normanno, scientific director of IRCCS Romagna Institute for the Study of Tumors, clinical adoption of targeted therapies in the EU lags behind medical guidelines, in part due to insufficient samples for tissue-based molecular profiling. Expanded availability of liquid biopsy testing should help address this, he said in a statement.

"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," added Guardant co-CEO Helmy Eltoukhy.

Since being introduced, Guardant360 has been used by more than 12,000 oncologists, with more than 500,000 tests performed to date, the company said.