New clinical utility data for Guardant360 platform to be presented at 2015 AACR Annual Meeting

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Guardant Health® today announced new clinical utility data for its Guardant360® platform, which will be presented at the 2015 American Association for Cancer Research (AACR) Annual Meeting in Philadelphia. This study, to be revealed at a poster session by MD Anderson Cancer Center investigators on Wednesday, April 22, highlights the performance and physician acceptance of biopsy-free tumor genomic profiling in metastatic colorectal cancer patients.

Through a simple blood draw, Guardant360 uses the cell-free DNA shed by tumors into blood to sequence and identify genomic alterations that can aid in personalized therapy selection. Previous studies have shown tumor analysis from blood to be concordant with tumor tissue when taken at the same time point. This cohort of 105 colorectal cancer patients builds upon these earlier studies:

  • Genomic alterations were found in 85 percent of patients with an average of 4.6 alterations per patient when testing with blood.
  • In 37 percent of the patients, physicians felt there was an actionable mutation and as such 56 percent of those patients were enrolled or were planning to be enrolled in a clinical trial.
  • A survey of participating physicians found that the blood test improved quality of care in 87 percent of the cases and improved patient satisfaction in 97 percent of the cases.
  • In 89 percent of the cases, the results from the blood test were available before results from the tissue test, and blood results were available for all cases versus 90 percent for tissue.
  • The investigators concluded the test could potentially obviate the need for repeat biopsies.

"A blood test for genomic profiling may provide increased clinical utility to physicians and patients as an accurate and timely alternative to tumor tissue biopsy," said the study lead, Dr. Scott Kopetz, Associate Professor GI Medical Oncology at the University of Texas MD Anderson Cancer Center. "By finding actionable mutations within the blood, we hopefully have a tool that can increase the number of patients eligible for clinical trials who may not have had the opportunity before due to the issues associated with tumor biopsies such as risk, cost and heterogeneity."

With only two vials of blood, Guardant360® digitally sequences billions of genomic data points to identify tumor genomic alterations with single molecule sensitivity at greater than 99.9999 percent specificity. Actionable genomic alterations and associated treatments are identified with none of the risks and half of the turnaround time of tissue biopsies. The Guardant360 platform gives oncologists and patients a simpler, faster and more accurate perspective of tumor genomic alterations and associated treatment options.

The data will be presented as a poster on Wednesday, April 22 from 8 a.m. – noon ET

Title: Prospective clinical application of circulating cell-free DNA sequencing in metastatic colorectal cancer
Abstract: 5236
Location: Section 22
Poster Board Number: 7
Presenters: Maria Pia Morelli, MD Anderson Cancer Center, Houston, TX

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