Guardant Health and Collaborators to Present 38 Abstracts Highlighting Breadth and Expanded Clinical Utility of Guardant Liquid Biopsy Tests Powered by InfinityAI at 2026 ASCO Annual Meeting
- New performance data demonstrates validity of Guardant360 Liquid CDx as a comprehensive pan-cancer companion diagnostic
- Findings show how Guardant360 Liquid CDx can expand access to targeted therapies by identifying actionable biomarkers missed by genomic testing
- Presentations reinforce Guardant’s role advancing genomic and epigenomic profiling, characterizing tissue-free MRD and recurrence monitoring, and expanding biomarker-guided precision oncology
Key data that will be presented include:
- Abstract #3077 validating the use of Guardant360 Liquid CDx as a companion diagnostic for therapy selection and comprehensive pan-cancer tumor profiling in routine oncology practice. Findings led to recent FDA approval of the IVD assay, marking the world’s largest FDA-approved liquid biopsy panel, demonstrating how incorporating both genomic and epigenomic signals for variant detection produces strong analytical sensitivity, accuracy, and specificity across clinically relevant alterations.
- Abstract #3070 revealing the potential of Guardant360 Liquid in expanding access to targeted ALK inhibitor therapy and getting the right treatment to lung patients faster. Demonstrating advanced detection missed by standard genomic methods, the analysis demonstrated improved detection of actionable ALK fusions in non-small cell lung cancer (NSCLC) while maintaining high specificity by identifying additional ALK fusion-positive cases.
- Abstract #TPS10632 evaluating longitudinal performance of the Shield blood test for primary colorectal cancer screening in its intended use population, building off the strong performance in the prospective, observational ECLIPSE study that led to FDA approval.
“Our presence at this year’s ASCO reflects the power of liquid biopsy tests to provide oncologists with actionable insights to more effectively treat patients in a faster amount of time,” said
Key
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Presentation |
Title |
Time / Location |
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8502 |
Lorlatinib vs crizotinib as first-line treatment for advanced ALK+ non-small cell lung cancer: 7-year update from the phase 3 CROWN study |
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3525 / 279 |
A deep learning approach to quantify tumor microenvironment features associated with postoperative ctDNA status and outcomes in a phase III FOLFOX-based adjuvant colon cancer trial (N0147; Alliance) |
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3546 / 313 |
A multicenter single-arm phase II trial evaluating the safety and efficacy of panitumumab and irinotecan in NeoRAS wild-type metastatic colorectal cancer patients (C-PROWESS) |
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3572 / 339 |
Circulating tumor DNA (ctDNA) tumor fraction (TF) dynamics to refine progression-free survival and radiographic response during anti-EGFR rechallenge in metastatic colorectal cancer |
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3659 / 426 |
Evaluation of circulating tumor DNA (ctDNA) burden, detected mutations and clinical outcomes in metastatic colorectal cancer (mCRC) using real-world data (RWD) |
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4050 / 33 |
Molecular circulating tumor DNA (ctDNA) profiling from patients (pts) treated with zanidatamab + chemotherapy (CT) in first-line (1L) HER2-positive (HER2+) advanced or metastatic gastroesophageal adenocarcinoma (mGEA) |
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4159 / 142 |
First-line GemCis ± immunotherapy vs FGFR inhibition in ctDNA-detected FGFR2 fusion-positive advanced cholangiocarcinoma: a real-world analysis |
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4161 / 144 |
Real-world analysis of epigenomic molecular tumor-type prediction for biliary tract cancer in CUP |
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4238 / 221 |
Real-world outcomes in gastrointestinal cancer patients with targetable genomic alterations identified on serial liquid biopsy |
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3051 / 188 |
Tumor-of-origin prediction using methylation signals from plasma cell-free DNA (cfDNA): Real-world experience in |
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3052 / 189 |
Tissue-free minimal residual disease evaluation and clinical utility in early breast cancer: a real-world study |
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3070 / 207 |
Cell-free DNA methylation profile-based fusion epigenotyping to enhance ALK fusion detection in NSCLC patients |
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3077 / 214 |
Analytical validation of a plasma-based cfDNA NGS assay (Guardant360 Liquid CDx) for comprehensive solid tumor profiling |
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3105 / 242 |
Phase II basket trial of brigatinib for ALK fusion–positive solid tumors: ALLBREAK trial (WJOG15221M) |
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1031 / 145 |
Concordance between liquid and tissue biopsy in participants with newly diagnosed recurrent breast cancer |
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|
1095 / 209 |
Liquid-based methylation profiling of molecular breast cancer subtypes (MBS) in hormone receptor positive (HR+) metastatic breast cancer (MBC) treated with CDK4/6 inhibitor (CDK4/6i) |
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The full abstracts for
About Guardant360® Liquid CDx
The largest FDA-approved liquid biopsy, Guardant360 Liquid CDx is the only FDA-approved liquid biopsy test integrating genomic and epigenomic data for comprehensive insights. Guardant360 Liquid CDx is approved as a companion diagnostic for multiple therapies in non-small cell lung cancer and colorectal cancer. It is also the only FDA-approved companion diagnostic for targeted therapy in advanced breast cancer patients with ESR1 mutations. The test is broadly covered by Medicare and commercial insurers, representing over 300 million lives.
About Guardant360 Liquid
Guardant360 Liquid is a blood-based test that analyzes tumor DNA fragments circulating in the blood (cfDNA) to identify genetic mutations in advanced solid tumors, helping oncologists find targeted therapies. It offers an alternative to tissue biopsies, providing comprehensive genomic profiling (CGP) to guide personalized treatment for a wide range of solid cancers including lung, breast, colorectal, and prostate cancer. Guardant360 Liquid is guideline-complete across all advanced solid tumors, and has been clinically validated in more than 1,500 publications and research abstracts.
About Guardant Reveal
Guardant Reveal is a tissue-free liquid biopsy test that detects minimal residual disease (MRD) and monitors recurrence in early-stage colorectal, breast, and lung cancers, helping oncologists guide treatment decisions. In addition to MRD detection, Reveal can be used for late-stage therapy response monitoring for patients with solid tumors. Guardant Reveal therapy response monitoring can be initiated at any time during a patient’s treatment journey, offering clinicians flexibility and actionable insights.
The first clinical-validation study of pan-cancer chemotherapy monitoring published in
About Shield
Shield is a methylation partitioning cell-free DNA (mp-cfDNA) non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.
About
Guardant Health Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended
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