First prospective clinical utility trial using comprehensive liquid biopsy to guide metastatic cancer patients to molecularly matched therapies demonstrates comparable results to tissue-based testing

REDWOOD CITY, Calif. and CHICAGO, June 6, 2016 /PRNewswire/ -- Guardant Health and Samsung Medical Center (Sungkyunkwan University School of Medicine, Korea) announced today the results of the first prospective clinical trial using a comprehensive liquid biopsy test as the sole diagnostic tool used by doctors to guide metastatic cancer patients to matched therapy across multiple cancers. The study used Guardant360®, the first and only comprehensive liquid biopsy that covers all guideline recommended biomarkers in a single test.

Liquid biopsies offer a promising approach for identifying druggable genomic alterations, without the need for costly and invasive tissue biopsies. NEXT-2 is the first prospective study to evaluate the response of advanced cancer patients to matched therapy based on ctDNA-detected alterations across different solid tumor cancers without tissue biopsies available for molecular testing. The study of 200 patients demonstrated high actionability in matching patients to targeted therapies, as well as statistically significant response rates in lung (88%) and gastric (60%) cancers. The data will be presented Monday June 6th in a scientific poster session at the American Society of Clinical Oncology Annual Meeting in Chicago, IL.

"We realized the importance of studying the clinical utility of such a novel test, and so shortly after the clinical validation of Guardant360 two years ago, we enrolled the first patient in NEXT-2," said Dr. Jeeyun Lee at Samsung Medical Center, the primary investigator on the study. "The results we have seen have been outstanding, and have certainly exceeded our expectations." Dr. Lee further added, "the genomic landscape of variants we found with Guardant360 were comparable to what we saw in NEXT-1, a tissue-based prospective clinical utility study. When these patients are then guided to matched therapy based on ctDNA profiling, the response rate was again comparable to what we see when selection is based on tumor specimens. This blood-based technology also overcomes tumor heterogeneity by providing a more global summary of all the aberrations in different metastatic sites. It also may reduce harm to patients by obviating the need for invasive biopsy."

This clinical outcome study is part of a broad set of data presented at the 2016 ASCO conference by independent investigators and oncologists using Guardant360. An oral presentation scheduled for Tuesday, June 7^th, provides the first ever population-scale ctDNA genomic landscape data using Guardant360 in clinical use.

"The data presented at ASCO this year helps to resolve two important questions regarding liquid biopsies," said Helmy Eltoukhy, co-founder and CEO of Guardant Health. "We addressed the first, about specificity and clinical validity, through a population-scale genomic landscape analysis of 15,000 patients, and the second, about clinical utility, has been addressed by the NEXT-2 prospective study, which demonstrated high clinical response rates across multiple cancer types. This is a great day for patients. With the evidence that liquid biopsies are both concordant with tissue, and useful for treating, clinicians have a tool for genotyping that doesn't bring with it the cost and potential harm of repeat invasive biopsies."

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 team is committed to positively and significantly impacting patient health through technology that addresses long-standing unmet needs in oncology.

SOURCE Guardant Health

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