A Medicare-covered tissue comprehensive genomic profiling (CGP) test with an AI-powered scoring algorithm that improves PD-L1 detection by >20% in non-small cell lung cancer (NSCLC), if ordered.1,2
Guardant360 TissueNext™ has the
CGP panel you need in a tissue test.1*
CGP test covering all guideline-recommended biomarkers.1
decisions in patients with advanced-stage cancer.3
2 to 3 weeks.1
This tissue CGP panel includes coverage of tumor mutation burden (TMB), microsatellite instability status (MSI), and PD-L1 IHC, if ordered.1
NSCLC guideline-recommended genes are shown in bold.
|Single Nucleotide Variants (SNVs) and Insertions and Deletions (Indels) (84 genes)|| Single Nucleotide Variants (SNVs) and Insertions and Deletions (Indels) |
| Copy Number Amplifications (CNAs) |
| Fusions |
|Mutations per megabase|
| PD-L1 Status |
|AI-powered PD-L1 for NSCLC from Guardant Galaxy. All other tumor types are evaluated using conventional methods.1,2|
Submit samples for processing with as low as 10% tumor fraction.
Testing specifications for Guardant360 TissueNext:
FFPE tissue block or
- 11 slides for tissue CGP only
- 15 slides for tissue CGP + PD-L1
Comprehensive support across the cancer continuum.
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For all advanced solid tumors.
Easy access to test ordering and management with simple order forms.
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Important Note: The Guardant360 TissueNext test was developed, and its performance characteristics determined, by the Guardant Health Clinical Laboratory in Redwood City, CA, USA, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. Guardant360 TissueNext refers to Guardant360 TissueNext Laboratory Developed Test (LDT). This test has not been cleared or approved by the US FDA.
*Non-small cell lung cancer patients who are negative from a plasma specimen for EGFR exon 19 deletions, L858R, T790M, EGFR exon 20 insertions, ERBB2/HER2 activating mutations, and KRAS G12C should be reflexed to tissue biopsy testing using an FDA approved tumor tissue test, if feasible.4 Note that “tissue CGP,” known as Guardant360 TissueNext, and “liquid CGP test," known as Guardant360, have not been cleared or approved by the FDA. For the complete intended use statement including companion diagnostic indications, please see Guardant360 CDx Technical Information.
†Includes TERT promoter region.
For a full list of diagnoses, download the Controlled Language for Diagnosis page.
For a full list of medical articles and drugs' Prescribing Information,
download the Gene Pocket Guide Reference List.