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NILE Study Results Demonstrating Guardant360’s High Concordance to Tissue Testing in Advanced NSCLC Published in Clinical Cancer Research

1132 Days ago

REDWOOD CITY, Calif., April 15, 2019 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq: GH), announced that the positive results from the NILE study, a head-to-head comparison of the Guardant360® assay to standard-of-care tissue testing for the identification of guideline-recommended biomarkers in first-line advanced non-small cell lung cancer (NSCLC) patients, have been published in Clinical Cancer Research1. The landmark study adds new data regarding Guardant360’s high concordance to tissue testing to the abstract that was highlighted before the AACR Annual Meeting and presented by the study’s senior author Vassiliki Papadimitrakopoulou, MD, Chief Section of Thoracic Medical Oncology, MD Anderson Cancer Center. The study adds to a growing body of literature2,3 demonstrating that using Guardant360 first for genomic biomarker detection in advanced NSCLC can increase the number of patients tested for guideline-recommended biomarkers.

Beyond meeting its primary endpoint of demonstrating that Guardant360 is as effective as standard-of-care tissue testing for the detection of guideline-recommended biomarkers in advanced NSCLC, investigators reported that using Guardant360 resulted in guideline- recommended testing for three times as many patients as standard-of-care tissue testing. Moreover, when results for Guardant360 and tissue testing were both available for a given patient, they were concordant in more than 90% of cases. Additionally, the median time to results for Guardant360 was 9 days versus 15 days for tissue testing. The study also showed that for EGFR L858R mutations, Guardant360’s clinical sensitivity was 90%.

“Not only do these results suggest that Guardant360 should be the first choice for obtaining genomic results for patients with advanced NSCLC, they demonstrate that standard-of-care tissue testing is failing to adequately genotype the vast majority of patients,” said Guardant Health Chief Executive Officer Helmy Eltoukhy, PhD. “For patients diagnosed with advanced lung cancer, each day spent waiting for test results is a day they are not treating their disease. By delivering results significantly faster than tissue, Guardant360 can reduce the time between testing and treatment.”

The NILE, or “Noninvasive versus Invasive Lung Evaluation” study is a prospective, multi-center study of 282 newly-diagnosed, advanced NSCLC patients. Each patient was tested with Guardant360 and the physician’s choice of tissue-based testing. Results of the tests were compared for the detection of the guideline-recommended biomarkers important for treatment selection in EGFR, ALK, BRAF, RET, ROS1, MET, and ERBB2. Knowing the status of these guideline-recommended biomarkers is important before beginning treatment for several reasons. Up to 30 percent of patients can be treated with targeted therapies that often have higher response rates than chemotherapy or immunotherapy. Moreover, patients who are eligible for these targeted drugs but are instead treated with immunotherapy may have worse outcomes.

Since its introduction in 2014, Guardant360 has been ordered by more than 6,000 oncologists for more than 100,000 patients with advanced cancer to help select treatment. The best-in-class performance of the assay is evidenced by more than 100 peer-reviewed publications, which address its analytical validity, clinical validity, and clinical utility in multiple tumor types.

About Guardant Health
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics.  Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs.  In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, such as statements about the expected impact of the NILE study data. Such statements reflect Guardant Health’s current expectations, forecasts and assumptions. Actual results may vary materially from forward-looking statements due to risks, uncertainties and other factors, known and unknown to Guardant Health as of the date hereof, such as those discussed in Guardant Health’s filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in its Quarterly Report for the period ended September 30, 2018 and in its subsequent filings with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release. Guardant Health disclaims any obligation to update any forward-looking statements, except as required by law.

Investor Contact:
Lynn Lewis or Carrie Mendivil

Media Contact:
Josh Wein or Ian Stone


1 Leighl NB, Page RD, Raymond, VM, et al. Clinical Utility of Comprehensive Cell-Free DNA Analysis to Identify Genomic Biomarkers in Patients with Newly Diagnosed Metastatic Non-Small Cell Lung Cancer, Clin Cancer Res. Published OnlineFirst April 15, 2019 doi: 10.1158/1078-0432.CCR-19-0624.

2 Aggarwal C, Thompson JC, Black TA, et al. Clinical Implications of Plasma-Based Genotyping With the Delivery of Personalized Therapy in Metastatic Non–Small Cell Lung Cancer. JAMA Oncol. 2019;5(2):173–180. doi:10.1001/jamaoncol.2018.4305

3 Gyawali B, West H Plasma vs Tissue Next-Generation Sequencing in Non–Small Cell Lung Cancer—Either, Both, or Neither? JAMA Oncol. 2019;5(2):148–149. doi:10.1001/jamaoncol.2018.4304

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