The updated liquid biopsy panel uses genomic and epigenomic insights to assist clinicians with treatment selection and tumor profiling.
The Food and Drug Administration (FDA) has approved Guardant360 Liquid CDx, a blood-based test that integrates genomic and epigenomic insights to help clinicians make treatment selection decisions for patients with advanced cancer.
The test evaluates a genomic footprint 100 times wider than the previously approved Guardant360 CDx to provide tumor profiling results, according to the company. The FDA approval also includes the transfer of seven previously approved companion diagnostic indications to the new test, according to a company release.
Powered by the company’s Smart Platform, the test combines genomic and epigenomic profiling from a single blood draw. This integration provides a several-fold increase in sensitivity for circulating tumor DNA detection over the previous version and reveals insights that genomics alone might miss, according to Guardant Health.
“Precision oncology is only as strong as the information clinicians have at the moment they need to make a decision,” says Helmy Eltoukhy, Guardant Health chairman and co-CEO, in a release. “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.”
The updated test provides results in as little as seven days, according to a release from the company. It is designed to provide information for clinical decisions regardless of tissue availability, line of therapy, or practice setting, according to the release.
The company’s full product portfolio is now upgraded to the Smart Platform, an AI-enabled multiomic technology designed to support clinical applications across the cancer care continuum from a single testing foundation.
