FDA approves New Guardant360 Liquid CDx, the largest FDA-approved liquid biopsy panel – Guardant Health
Guardant Health announced that the FDA has approved Guardant360 Liquid CDx, advancing blood-based comprehensive genomic testing by integrating genomic and epigenomic insights and helping clinicians make better-informed treatment selection decisions for patients with advanced cancer. Guardant360 Liquid CDx is the largest FDA-approved liquid biopsy panel, assessing a 100X wider genomic footprint than the previously approved Guardant360 CDx to deliver comprehensive tumor profiling results. The seven previously FDA-approved companion diagnostic indications for Guardant360 CDx transfer to the new test with the FDA approval of Guardant360 Liquid CDx.
Guardant360 Liquid CDx is powered by Guardant’s Smart Platform, which unlocks new dimensions of tumor biology by integrating genomic and epigenomic profiling from a single blood draw, providing a several-fold increase in sensitivity for circulating tumor DNA (ctDNA) detection from the previous Guardant360 CDx test and revealing clinically actionable insights that genomics alone may miss.
“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.” – Helmy Eltoukhy, Guardant Health chairman and co-CEO.
Guardant360 Liquid CDx builds on Guardant’s leadership pioneering the first FDA-approved comprehensive liquid biopsy. Building on this track record, the test also is the first liquid biopsy to simultaneously define both the genotype and key phenotype information, taking precision oncology to the next level. The updated test delivers fast results in as little as seven days, providing the information needed for clinical decisions regardless of tissue availability, line of therapy, or practice setting.
Guardant’s full product portfolio is now upgraded to its proprietary Smart Platform, an AI-enabled multiomic technology platform behind its next generation of cancer tests, supporting new clinical applications across the cancer care continuum from a single, scalable testing foundation.
About Guardant360 Liquid CDx
The largest FDA-approved liquid biopsy, Guardant360 Liquid CDx is the only FDA-approved liquid biopsy test integrating genomic and epigenomic data for comprehensive insights. Guardant360 Liquid CDx is approved as a companion diagnostic for multiple therapies in non-small cell lung cancer and colorectal cancer. It is also the only FDA-approved companion diagnostic for targeted therapy in advanced breast cancer patients with ESR1 mutations. The test is broadly covered by Medicare and commercial insurers, representing over 300 million lives.
