NILE Study: Large prospective head-to-head trial finds Guardant360 is as effective as tissue testing in detecting NSCLC biomarkers

Key Findings

  • Concordance between Guardant360 and tissue testing was greater than 90% for the four biomarkers with FDA-approved therapies
  • Guideline-recommended biomarker testing was completed for 95% of patients with Guardant360 vs 31% with standard-of-care tissue testing
  • Turnaround time was ~1 week faster with Guardant360 vs. SOC tissue testing

"In a landscape where a large fraction of our patients never get their tumor genotyped because of insufficient tissue or sequential tissue testing, it would make sense to adopt a strategy where blood is used first to detect alterations."


Dr. Vassiliki A. Papadimitrakopoulou
Department of Thoracic Head and Neck Medical Oncology MD Anderson Cancer Center

Study Overview

A head-to-head, prospective, multicenter trial compared Guardant360 vs standard-of-care tissue testing for biomarker detection in 282 newly diagnosed patients with advanced NSCLC

Points for your practice

Guardant360 performed similarly to tissue in the detection of guideline-recommended biomarkers

Guardant360 enabled more complete biomarker assessment than tissue testing

Faster test results and less time waiting to make treatment decisions

Guardant360 provides test results in 9 days vs 15 for tissue

Guardant360-first testing finds more patients than tissue-first testing

NILE Study Review

Dr. Vassiliki A. Papadimitrakopoulou,
MD Anderson Cancer Center

Clinical Utility of Comprehensive Cell-Free DNA Analysis to Identify Genomic Biomarkers in Patients with Newly Diagnosed Metastatic Non-Small Cell Lung Cancer

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