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Guardant360 CDx Receives CE Mark for Tumor Mutational Profiling and Tagrisso CDx Use

NEW YORK – Guardant Health said today that its Guardant360 CDx liquid biopsy test has received the CE mark for tumor mutation profiling in cancer patients with any solid tumor. The assay is also approved as a companion diagnostic to identify non-small cell lung cancer patients who may benefit from treatment with osimertinib (AstraZeneca's Tagrisso).

Guardant360 CDx is a targeted sequencing assay performed on blood samples, which detects alterations in a panel of 55 genes with established actionability in guiding the use of molecularly targeted cancer drugs.

The test received US Food and Drug Administration approval for these same indications in August 2020, and Guardant CEO Helmy Eltoukhy said in a statement that extending this to a CE mark is an important step in now making the assay internationally accessible.

"We are committed to helping cancer patients be comprehensively tested to see if they are appropriate for potentially life-changing personalized treatments," Eltoukhy said.

While the assay is only approved for the one companion diagnostic indication so far, Guardant is collaborating with several pharmaceutical companies including Amgen, Janssen Biotech, and Radius Health to establish Guardant360 as a response predictor for other drugs.