Unlock the most dynamic view of cancer
with our revolutionary precision oncology tests.
Unlock the most dynamic view of cancer with our revolutionary precision oncology tests.
Our liquid and tissue tests answer critical questions across the cancer care continuum—providing end-to-end insights with the convenience of a single testing partner.1-5
turnaround time6,8
solid tumors3
—
*Median turnaround time from sample receipt to results.
†For stage I-IV CRC patients being treated with curative intent, both for adjuvant decision-making after surgery and for longitudinal surveillance every 3 to 6 months.
‡For IO monitoring for all advanced solid tumors.
§As a professional service, Guardant360 CDx reports mutations in 74 genes. This report has not been reviewed or approved by the FDA.
||Guardant360 TissueNext can be ordered as a standalone or with Guardant360 CDx liquid biopsy. Liquid and tissue testing may be initiated at the same time, but sample processing does not occur concurrently. Once the Guardant360 CDx liquid results have been delivered, confirmation of medical necessity is required to proceed with Guardant360 TissueNext. Patients who have a negative Guardant360 CDx test result for an indicated companion diagnostic biomarker should be reflexed to tissue biopsy testing using an FDA-approved tumor tissue test, if feasible.
¶Excluding patients with central nervous system tumors.
AI, artificial intelligence; MRD, minimal residual disease; MSI, microsatellite instability; PD-L1, programmed death-ligand 1; TMB, tumor mutation burden.
Important note: Guardant Reveal, Guardant360 Response, Guardant360, and Guardant360 TissueNext were developed as Laboratory Developed Tests (LDTs), and their 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. These tests have not been cleared or approved by the US FDA.
References: 1. Guardant Health data on file. October 19, 2023. Guardant Health, Inc. Redwood City, CA. 2. Guardant360 ResponseTM: Guide to Ordering Guardant360 Response. Guardant Health, Inc. Redwood City, CA. 3. Guardant360® CDx Technical Information. Guardant Health, Inc. Redwood City, CA. February 2023. 4. Guardant360® Assay Specifications. October 14, 2024. Guardant Health, Inc. Redwood City, CA. 5. Guardant360 TissueNextTM Assay Specifications. Guardant Health, Inc. Redwood City, CA. 6. Guardant Health data on file. September 27, 2024. Guardant Health, Inc. Redwood City, CA. 7. Guardant360® Assay Specifications. 2019. Guardant Health, Inc. Redwood City, CA. 8. FDA News Release. FDA approves first liquid biopsy next-generation sequencing companion diagnostic test. August 7, 2020. Updated August 11, 2020. Accessed October 8, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test 9. Guardant360® CDx Assay Specifications. Guardant Health, Inc. Redwood City, CA. 10. Choi S, Cho SI, Ma M, et al. Artificial intelligence–powered programmed death ligand 1 analyser reduces interobserver variation in tumour proportion score for non–small cell lung cancer with better prediction of immunotherapy response. Eur J Cancer. 2022;170:17-26. doi:10.1016/j.ejca.2022.04.011 11. Guardant Health data on file. April 1, 2024. Guardant Health, Inc. Redwood City, CA.