REDWOOD CITY, Calif., Oct. 20, 2015 /PRNewswire/ -- Guardant Health®, the leader in liquid biopsies, announced the publication of two peer-reviewed studies demonstrating the superior performance of its non-invasive Guardant360® test over highly invasive tissue-based genomic testing.
The first study, in the paper entitled "Analytical and Clinical Validation of a Digital Sequencing Panel for Quantitative, Highly Accurate Evaluation of Cell-free Circulating Tumor DNA," appears in the October issue of PLOS One. The eight-center, prospective validation study involved 165 patients with a variety of cancer types. It demonstrates Guardant360® to be highly accurate, with higher sensitivity and near-perfect specificity when compared to tissue-based next-generation sequencing.
"Before Guardant360®, highly-invasive tissue-based next-generation sequencing (NGS) biopsies were the only way oncologists and their patients with advanced cancers could match tumor genomic signatures to targeted therapies," said Helmy Eltoukhy, co-founder and CEO at Guardant Health. "This multi-center peer-reviewed study shows that there is a new paradigm in genomic-based comprehensive tumor testing that obviates the need for invasive tissue biopsies."
"Guardant360® is the only test that non-invasively and comprehensively interrogates evolving genomic signatures for advanced cancers, which is useful for both therapy selection and treatment response monitoring," said Dr. Richard Lanman, Chief Medical Officer at Guardant Health and lead author of the PLOS One study. "Our test poses none of the costs, complications and delays inherent in tissue biopsies. Furthermore, tissue biopsies struggle to capture tumor heterogeneity, which may be reflected in the limited sensitivity of tissue-based NGS seen in the PLOS One study. Our proprietary digital sequencing method has 99.9999% specificity, the highest of any NGS based test. These studies demonstrate that oncologists can confidently make treatment decisions when Guardant360® reports an actionable mutation."
The second paper, entitled "Prospective blinded study of somatic mutation detection in cell-free DNA utilizing a targeted 54-gene next generation sequencing panel in metastatic solid tumor patients," by Kim et al., appears in the October edition of Oncotarget. This 75-patient study of 61 pan-cancer metastatic patients and 14 stage II colorectal cancer patients demonstrated high concordance between Guardant360® and tissue-based sequencing methods.
The Oncotarget-published study also demonstrated encouraging results for using Guardant360® in treatment monitoring. In several post-operative stage II patients, Guardant360® detected new actionable mutations months before radiological progression. This study also demonstrated a correlation between patients who presented post-operative residual disease and poor clinical outcomes.
"Though this monitoring test was done on a modest scale, it is a promising indication that Guardant360® may be able to be used earlier in the cancer-care continuum to improve patient outcomes," Eltoukhy said.
The PLOS One and Oncotarget publications build on other recent publications, in Clinical Cancer Research (Aug 2015) and Cancer Discovery (June 2015), demonstrating a growing amount of evidence of the clinical utility of Guardant360® across many cancer types.
With two vials of blood, Guardant360® digitally sequences more than 10 billion genomic data points to identify tumor genomic alterations at greater than 99.9999 percent specificity. Actionable genomic alterations and associated treatments are identified in about half the time and with none of the risk of tissue biopsies. The Guardant360® platform gives oncologists and patients a simpler, faster, and more accurate perspective of their treatment options, and may identify targeted therapies for genomic alterations.
It is the only cfDNA test that includes all NCCN somatic genomic targets in a single test. Unlike hotspot tests, Guardant360® sequences complete exons so as not to miss uncommon or rare mutations in the 70 genes. The 70-gene comprehensive diagnostic test is used in advanced cancer patients with visceral solid tumor cancers or metastases, and includes all four major types of pertinent genomic alterations. Guardant Health's Molecular Tumor Board reports on actionable genomic alterations: those for which there is an FDA-approved on- or off-label treatment, or that imply eligibility for later phase clinical trials, and physicians may review these reports in their physician portal.
About Guardant Health
Guardant Health, headquartered in Redwood City, Calif., is developing breakthrough diagnostics to transform cancer from a silent killer into a manageable disease. The company is the liquid biopsy market leader and has raised $100 million from Sequoia Capital, Khosla Ventures, Lightspeed Venture Partners, and others. Guardant Health was founded in 2012 by a team of serial entrepreneurs with expertise in next-generation sequencing, single-cell genomics, and cancer diagnostics and its first product, Guardant360®, came to market in 2014. The team is committed to improving patient health through technology that addresses long-standing unmet needs in oncology. The World Economic Forum named Guardant Health a 2015 Technology Pioneer.
SOURCE Guardant Health