Guardant Health® and Collaborators Present Further Clinical Utility Data for Guardant360® at the AACR-NCI-EORTC International Conference On Molecular Targets and Cancer Therapeutics

Guardant360 is the world's most validated comprehensive liquid biopsy platform with more than 30 scientific presentations and peer-reviewed publications in 2015

Nov 09, 2015, 07:00 ET from Guardant Health

REDWOOD CITY, Calif., Nov. 9, 2015 /PRNewswire/ -- Guardant Health®, the leader in liquid biopsies, announced today the presentation of eight scientific posters by collaborators from leading cancer centers and Guardant Health that highlight the performance and clinical utility of Guardant360® at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. The presentations were made by researchers from Dana-Farber Cancer Institute, and Belfer Institute for Applied Cancer Science, Boston; Duke University, Durham, N.C.; Levine Cancer Center, Carolinas HealthCare System, Charlotte, N.C.; MD Anderson Cancer Center, Houston; Moores Cancer Center, University of California, San Diego; Pacific Medical Center of Hope, Fresno, Calif.; and Guardant Health.

These presentations add to the mounting clinical evidence of Guardant360's utility. With more than 30 presentations and publications in 2015, Guardant360 is the world's most validated comprehensive liquid biopsy platform.

"The increasing scientific and commercial adoption of Guardant360 has been unprecedented, and we attribute this to the unrivaled performance of our platform," said Helmy Eltoukhy, co-founder and CEO of Guardant Health. "The near-perfect specificity provided by our digital sequencing platform means that oncologists can confidently make treatment decisions when Guardant360 reports an actionable mutation. We expect the demand for Guardant360 to continue to grow rapidly because it provides comprehensive profiling of solid tumors with none of the costs, complications or delays inherent in tissue biopsies. Furthermore, tissue-based sequencing struggles to capture tumor heterogeneity, and it cannot capture evolving mutations upon disease progression without repeated invasive biopsies, as highlighted by some of the presentations."

For example, in work presented at the conference by Strickler from Duke University, MET amplifications were found to be an important and treatable resistance mechanism in metastatic colorectal carcinoma after progression on EGFR antibody therapy. MET copy number variations identified by Guardant360 were validated by response to treatment and/or concordance with CTC-based MET protein FISH assays. MET amplification is rare in primary tumors and hence will not be captured by tissue sequencing methods, without repeated invasive biopsies upon disease progression.

Guardant Health's proprietary digital sequencing method has greater than 99.9999% specificity, the highest of any NGS-based test. It provides full exon sequencing of 70 genes that captures all current NCCN recommended somatic genomic targets, and reporting of all four major classes of alterations including point mutations (SNVs), indels, copy number amplifications (CNV's) and fusions. To capture all guideline-recommended genotyping without an invasive biopsy, Guardant360 is the first choice for an increasing number of leading physicians globally, already serving more than 1,500 leading oncologists and tens of thousands of cancer patients per year across hundreds of cancer centers.

The presentations:

Subject: Genomic profiling of over 5,000 consecutive cancer patients with a CLIA-certified cell-free DNA NGS test: Analytic and clinical validity and utility
Lead Author: Kimberly C. Banks, MS, CGC, Guardant Health, Inc., Redwood City, CA

Subject: Next-generation sequencing of biopsy-free circulating tumor DNA revealed frequent actionable alterations in advanced hepatocellular carcinoma
Lead Author: Sadakatsu Ikeda, MD, University of California, San Diego, La Jolla, CA

Subject: Development of EGFR C797S mutation in serial liquid biopsy assessments in the clinical practice setting
Lead Author: Kathryn F. Mileham, MD, Levine Cancer Institute, Charlotte, NC

Subject: Circulating cell-free DNA as a marker for response and resistance to BRAF and EGFR inhibition in BRAF-mutated metastatic colorectal cancer
Lead Author: Van Morris, MD, MD Anderson Cancer Center, Houston, TX

Subject: Impact of multi targeted epigenetic therapy (MTET): a series of 100 consecutive advanced solid tumor cancers
Lead Author: M. A. Nezami, MD, Pacific Medical Center of Hope, Fresno, CA

Subject: Differentiating somatic and germline variants using targeted next-generation sequencing (NGS) of cell-free plasma DNA (cfDNA)
Lead Author: Geoffrey R. Oxnard, MD, Dana-Farber Cancer Institute, Boston, MA; 2Belfer Institute for Applied Cancer Science, Boston, MA; 3Guardant Health, Redwood City, CA

Subject: Use of liquid biopsies in clinical oncology: the UCSD Moores Cancer Center experience in 168 patients with diverse malignancies
Lead Author: Maria C. Schwaederle, PharmD, Center for Personalized Cancer Therapy, UCSD Moores Cancer Center, La Jolla, CA

Subject: Cell free DNA (cfDNA) to monitor clonal evolution in patients (pts) with KRAS wild-type (WT) metastatic colorectal cancer (mCRC): Preliminary results of a phase I/II clinical trial of the anti-MET multi-kinase inhibitor cabozantinib (C) plus the anti-EGFR monoclonal antibody panitumumab (P)
Lead Author: John H. Strickler, MD, Duke University, Durham, NC

About Guardant360
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.

Guardant360 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 focused on developing breakthrough diagnostics that can transform cancer from a silent killer into a manageable disease. Guardant Health was founded in 2012 by a team of serial entrepreneurs with expertise in next-generation sequencing, single-cell genomics, and cancer diagnostics. The company has raised $100 million in funding from leading venture capital firms and its first product, Guardant360, came to market in 2014. The team is committed to positively and significantly impacting patient health through technology that addresses long-standing unmet needs in oncology. The World Economic Forum named Guardant Health a 2015 Technology Pioneer.

Media Contact:
Mark de la Vina
Consort Partners for Guardant Health
Phone:  415-282-4795


SOURCE Guardant Health