Guardant Health Partners With National Cancer Institute On First Ever Prospective Study To Implement cfDNA Genomic Profiling For Non-Small Cell Lung Cancer

REDWOOD CITY, Calif., June 24, 2015 /PRNewswire/ -- Guardant Health®, the market leader in liquid biopsies, today announced that it has partnered with the National Cancer Institute (NCI)-funded SWOG on a study to use cell-free DNA testing to identify mechanisms of resistance and future treatment options in non-small cell lung cancer (NSCLC), one of the most pervasive forms of the disease. SWOG, a nationwide cancer research cooperative group that designs and conducts clinical trials, has chosen Guardant360® as the blood test for a tumor genomic profiling study of approximately 600 lung cancer patients, making it one of the largest scale prospective studies using liquid biopsy techniques. The study will test patients at the time of enrollment and upon progression with cell-free DNA. The cell-free DNA test will be used to adjust therapy as appropriate for those patients progressing after first line treatment.

"Using blood to test changes in the genomic makeup of cancer allows us to obtain multiple specimens over time, something that is challenging to do with tissue biopsy," said Dr. David Gandara, MD, a leading thoracic oncologist and Chair of the SWOG Lung Cancer Committee. "A blood test is also relatively non-invasive and inexpensive when compared with tissue biopsy. Both physicians and patients like the idea of a non-invasive test to monitor their cancer. NSCLC is an ideal tumor type to test this novel technology due to the known genomic complexity and evolution of this genomic landscape after therapy. In the case of patients with EGFR-mutated lung cancer, patients may fail first-line treatment due to the emergence of the T790M resistance mutation, which is one of the targets that Guardant360 will be used to detect."

"We are honored to have been selected by SWOG for this trial as it reaffirms our commitment to providing the highest level of quality and utility in tumor genomic profiling," said Guardant Health CEO and co-founder Helmy Eltoukhy. "Biopsy-free testing brings transformative new options to clinical trials and we look forward to working with our partners to demonstrate its impact on accelerating clinical research."

The SWOG trial, known as SWOG-1403, will examine the potential that combination EGFR blockade, with cetuximab and afatinib, will be superior to afatinib alone as a frontline treatment for 600 patients with newly diagnosed EGFR-mutant non-small cell lung cancer.  During the trial, blood samples will be taken at the time of enrollment and upon progression. Physicians will be blinded to results until the time of progression so that they can adjust treatment accordingly.

Today's announcement underscores Guardant Health's commitment to demonstrating clinical utility of Guardant360 in multiple cancer types. Last month, the company presented further clinical utility data in glioblastoma, pancreatobiliary carcinomas, and colorectal cancer in conjunction with collaborators at University of California, San Diego; University of California, San Francisco; and MD Anderson Cancer Center.  An earlier study at MD Anderson demonstrated higher quality of care for metastatic colorectal cancer patients using Guardant360.  The company also unveiled the Tumor Response Map, a new visual language for tumor genomics, making it easier for physicians to quickly identify changes over time in their patients.  Data on lung cancer generated in collaboration with Philip Mack, Ph.D., Director of Molecular Pharmacology at the UC Davis Comprehensive Cancer Center, will be presented at the upcoming World Conference on Lung Cancer in September.

About Guardant360
With only 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 turnaround-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, resulting in targeted therapies for genomic alterations.

About SWOG
SWOG Cancer Research is a consortium that designs and conducts multidisciplinary clinical trials to improve the practice of medicine in preventing, detecting, and treating cancer, and to enhance the quality of life for cancer survivors. The approximately 5,000 physician-researchers – along with 5,000 other research professionals – in the group's network practice at more than 900 institutions nationwide, including 32 of the National Cancer Institute (NCI)-designated cancer centers, as well as cancer centers in almost a dozen other countries. Formerly the Southwest Oncology Group, SWOG is part of the NCI's National Clinical Trials Network and is supported primarily through NCI research grant funding. The group is headquartered at the Knight Cancer Institute at the Oregon Health & Science University in Portland, Oregon, (503-494-5586), has an operations office in San Antonio, Texas, and has a statistical center in Seattle, Washington. Its non-profit arm, The Hope Foundation, operates in Ann Arbor, Michigan. Learn more at swog.org (@SWOG).

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. 

Media Contact:
Mark de la Vina
Consort Partners for Guardant Health
Email: [email protected]
Phone: 415-282-4795

SOURCE Guardant Health