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# FDA Approves Guardant Health’s Next-Generation Guardant360 Liquid CDx
- URL: https://www.fdaweb.com/fda-approves-guardant-healths-next-generation-guardant360-liquid-cdx/
- Published: 2026-05-20T12:00:00.000Z
- Updated: 2026-09-14T13:39:34.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161180

FDA has approved Guardant Health’s next-generation Guardant360 Liquid CDx, a blood-based comprehensive genomic profiling test designed to provide both genomic and epigenomic insights for patients with advanced cancer. The company says the newly approved assay replaces the earlier Guardant360 CDx platform and transfers all seven previously approved companion diagnostic indications to the updated test.

According to Guardant, the new liquid biopsy panel is the largest FDA-approved liquid biopsy test currently available and evaluates a genomic footprint approximately 100 times larger than the prior Guardant360 CDx assay. The company says the platform combines genomic and epigenomic profiling from a single blood draw to improve circulating tumor DNA detection sensitivity and identify clinically actionable information that may not be captured through genomic analysis alone.

The company says Guardant360 Liquid CDx is powered by the company’s proprietary Smart Platform, an artificial intelligence-enabled multiomic technology platform that integrates data from genomic and epigenomic analyses. Guardant said the system was developed using insights from more than one million patient tests.

**Helmy Eltoukhy**, company chairman and co-CEO, says the approval represents a significant step toward broader adoption of precision oncology tools that can provide more comprehensive molecular profiling information through minimally invasive testing.

The company says the updated test can return results in as little as seven days and is intended to support treatment selection decisions regardless of tissue availability, line of therapy, or clinical setting.

Guardant360 Liquid CDx is approved as a companion diagnostic for multiple therapies in non-small cell lung cancer and colorectal cancer and is also approved as a companion diagnostic for targeted therapies in advanced breast cancer patients with ESR1 mutations, according to the company.