FDA Approves Expanded Liquid Biopsy Panel for Advanced Cancer Profiling

Timely, comprehensive tumor profiling helps clinicians make treatment selection decisions for patients with advanced cancer. Blood-based approaches can provide actionable insights from a simple draw and support decisions when tissue is limited. A newly FDA approved test now integrates genomic and epigenomic insights to expand the clinical footprint of liquid biopsy for treatment planning. 

Guardant360 Liquid CDx has been approved by the U.S. Food and Drug Administration (FDA) as the largest FDA‑approved liquid biopsy panel. The assay assesses a 100-fold wider genomic footprint than the previously approved Guardant360 CDx and delivers comprehensive tumor profiling results. With this approval, seven previously FDA‑approved companion diagnostic indications for Guardant360 CDx transfer to the new test. 

Powered by the Smart Platform, the assay integrates genomic and epigenomic profiling from a single blood sample and provides a several‑fold increase in sensitivity for circulating tumor DNA (ctDNA) detection versus the prior test, revealing clinically actionable insights that genomics alone may miss. Results are available in as little as seven days, enabling decisions regardless of tissue availability, line of therapy, or practice setting. The test is described as the first liquid biopsy to simultaneously define genotype and key phenotype information; this capability is delivered via a professional service report that is not reviewed or approved by the FDA. 

Guardant360 Liquid CDx is approved as a companion diagnostic for multiple therapies in non‑small cell lung cancer (NSCLC) and colorectal cancer, and it is the only FDA‑approved companion diagnostic for targeted therapy in advanced breast cancer patients with ESR1 mutations. The platform also supports a unified testing experience across liquid and tissue.

“Precision oncology is only as strong as the information clinicians have at the moment they need to make a decision. With FDA approval of the new Guardant360 Liquid CDx, cancer care enters a new era: one where genomics, epigenomics, advanced AI, and learnings from more than one million patients tested converge to deliver a more complete, actionable view of cancer from just a blood draw. This approval moves us closer to a future where every physician has the right information at the right time to make the right decision," said Helmy Eltoukhy, Guardant Health chairman and co‑CEO.

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