Predict treatment response before standard imaging.1
Assess response to IO and targeted therapy with a single draw 4 - 10 weeks after starting therapy initiation.3
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Guardant360 Response™—the only tissue-free biopsy to measure treatment response.1
>50% reduction in ctDNA is associated with a significantly longer PFS.1,2
Overview
Key features for Guardant 360 Response
Assess changes in ctDNA to help clarify equivocal scans.1
Results in under 2 weeks.*
Predict response before standard imaging.1
Covered by Medicare for patients receiving immunotherapy.†
Guardant360 tests are covered across 300 million lives with all major insurers, including Aetna, Anthem, Cigna, United Healthcare, and others.
Important note: The Guardant360 Response and Guardant360 tests were developed, 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. Guardant360 Response refers to Guardant360 Response Laboratory Developed Test (LDT), and Guardant360 refers to the Guardant360 LDT. These tests have not been cleared or approved by the US FDA. Guardant360 CDx is not approved by the US FDA to assess treatment response or long-term survival.
*Turnaround time of under 2 weeks is from sample receipt to results.
†For patients with advanced solid tumor cancers, placed on immunotherapy. Testing must occur 4-10 weeks after therapy initiation.
‡Samples submitted >20 weeks after the baseline blood draw will not be accepted.
ctDNA, circulating tumor DNA; IO, immunotherapy; NSCLC, non-small cell lung cancer; PFS, progression-free survival.
References: 1. Zhang Q, Luo J, Wu S, et al. Prognostic and predictive impact of circulating tumor DNA in patients with advanced cancers treated with immune checkpoint blockade. Cancer Discov. 2020;10(12):1842-1853. doi:10.1158/2159-8290.CD-20-0047 2. Thompson JC, Carpenter EL, Silva BA, et al. Serial monitoring of circulating tumor DNA by next-generation gene sequencing as a biomarker of response and survival in patients with advanced NSCLC receiving pembrolizumab-based therapy. JCO Precis Oncol. 2021;5:510-524. doi:10.1200/PO.20.00321 3. Guardant360 ResponseTM: Guide to ordering Guardant360 Response. Guardant Health, Inc. Redwood City, CA.