FDA OKs Updated Guardant360 Liquid CDx with Expanded Molecular Profiling

The FDA has approved the new Guardant360 Liquid CDx, an updated blood-based cancer test designed to support treatment selection in patients with advanced cancer, according to a press release from the developer, Guardant Health, Inc.¹ The molecular profiling assay expands on the previously approved Guardant360 CDx and retains its 7 FDA-approved companion diagnostic indications across multiple tumor types.

By incorporating advanced AI and data from more than 1 million patients who underwent testing, the platform offers a non-invasive, blood-based method to deliver results within 7 days regardless of tissue availability, practice setting, or line of therapy. Helmy Eltoukhy, chairman and co-chief executive officer of Guardant Health, emphasized the therapeutic role of the system, stating: “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 1 million patients tested converge to deliver a more complete, actionable view of cancer from just a blood draw.”¹

What dimensions of tumor biology are assessed by the updated Guardant360 Liquid CDx?

The newly approved version of the Guardant360 Liquid CDx panel evaluates a genomic footprint that is 100 times wider than the earlier Guardant360 CDx test. Powered by the developer's proprietary Smart Platform, the AI-enabled technology simultaneously tracks genotype and key phenotype information.

As a companion diagnostic tool, the system identifies actionable mutations that direct treatment options across several disease types, including non–small cell lung cancer (NSCLC) and colorectal cancer. Additionally, it stands as the only FDA-approved liquid biopsy companion diagnostic for targeted therapy selection in patients with advanced breast cancer harboring ESR1 mutations. Following this regulatory action, the 7 previously established companion diagnostic indications assigned to the original Guardant360 CDx system will officially transfer over to the new Guardant360 Liquid CDx assay.¹

They include identifying:

• Patients with breast cancer with ESR1 mutations for vepdegestrant (Veppanu) treatment.²
• Patients with BRAF V600E-mutant metastatic colorectal cancer for treatment with encorafenib (Braftovi), cetuximab (Erbitux), and chemotherapy.³
• Patients with NSCLC harboring EGFR exon 19 deletions, L8F8R, and T790M; EGFR exon 20 insertions; HER2-activating mutations; or KRAS G12C mutations who are eligible for treatment with osimertinib (Tagrisso), amivantamab-vmjw (Rybrevant), fam-trastuzumab deruxtecan-nxki (Enhertu), and sotorasib (Lumakras), respectively.⁴

How is the testing platform structured for clinical deployment?

The test evaluates genomic alterations across all solid tumors, sorting identified variants into strict clinical evidence categories. The multiomic platform incorporates data derived from more than 1 million patients and is designed for use across multiple stages of cancer care, including treatment selection, recurrence monitoring, and cancer screening. The diagnostic assay is broadly covered by Medicare and commercial insurers, representing over 300 million lives covered across the US.

“This approval moves us closer to a future where every physician has the right information at the right time to make the right decision,” Eltoukhy added.¹

References

1. FDA approves new Guardant360 Liquid CDx, the largest FDA-approved liquid biopsy panel with a 100x expanded footprint. News release. Guardant Health, Inc. May 20, 2026. Accessed May 22, 2026. https://tinyurl.com/yvf63uej
2. FDA approves vepdegestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. News release. FDA. May 1, 2026. Accessed May 22, 2026. https://tinyurl.com/yzf47dj2
3. Guardant Health receives FDA approval for Guardant360® CDx as companion diagnostic for BRAFTOVI® (encorafenib) combination in patients with BRAF V600E-mutant metastatic colorectal cancer. News release. Guardant Health, Inc. January 22, 2026. Accessed May 22, 2026. https://tinyurl.com/484bvk33
4. Guardant360 CDx technical information. Guardant Health, Inc. Accessed May 22, 2026. https://tinyurl.com/3hxn42n3