Guardant360 Tissue

Clinical Use

Use

Guardant360 Tissue is a next-generation sequencing (NGS)–based comprehensive genomic profiling assay for patients with advanced solid tumors that integrates DNA, RNA, and epigenomic analysis from tumor tissue. The test identifies clinically relevant genomic alterations and molecular signatures to support therapy selection, including targeted treatments and immunotherapy, and is intended for use in accordance with established oncology guidelines to inform treatment decisions across solid tumor types.

Special Instructions

Guardant360 Tissue is performed on tumor tissue specimens and is designed to maximize molecular insights from limited samples, requiring significantly less tissue surface area than traditional approaches. Testing is conducted in Guardant Health’s CLIA-certified laboratory, with results typically available in under two weeks, and orders can be placed through standard laboratory workflows including digital and integrated ordering systems.

Limitations

Guardant360 Tissue relies on adequate tumor tissue for analysis, and test performance may be impacted by insufficient tumor content or sample quality. As with all genomic profiling assays, a negative result does not exclude the presence of alterations below the limit of detection, and interpretation of findings should be considered in the context of clinical and pathological information. Multiomic features, including epigenomic signals, may provide additional insights but are not uniformly associated with established therapeutic guidelines.

Test Details

Methodology

NGS (CGP)

Biomarkers

2 components

DNA Sequencing • CGPRNA Sequencing • CGP

Result Turnaround Time

10-14 days

Specimen

Tissue (FFPE)

Volume

Not provided

Minimum Volume

Typically ≥5 unstained slides or equivalent FFPE tissue block

Container

Formalin-fixed paraffin-embedded (FFPE) slides or tissue block

Collection Instructions

Submit FFPE tumor tissue from a recent surgical resection or biopsy. Samples should meet minimum tumor content requirements and be prepared according to standard histopathology protocols. Pathology review may be required to confirm adequacy prior to testing.