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Guardant Health Initiates ORACLE Study to Evaluate Performance of Guardant Reveal™ Blood Test to Predict Recurrence Across Early-Stage Cancers
1,000-patient prospective study in 11 solid tumors will monitor ctDNA levels up to five years REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc.
About this update from Guardant Health, Inc.
[{"type":"text","content":"\n1,000-patient prospective study in 11 solid tumors will monitor ctDNA levels up to five years\n\n REDWOOD CITY, Calif.--(BUSINESS WIRE)--\nGuardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, has initiated the Observation of ResiduAl Cancer with Liquid biopsy Evaluation (ORACLE) study, a 1,000-patient prospective, observational, multi-center study designed to evaluate the performance of its Guardant Reveal™ liquid biopsy test to predict cancer recurrence after curative intent treatment, across 11 solid tumor types.\n\n“For oncologists managing patients with early-stage cancer, there is a need for additional tools to help make informed decisions regarding risk for recurrence and benefit of adjuvant therapies, and avoid under- or over-treatment,” said Craig Eagle, MD, Guardant Health Chief Medical Officer. “This study is exciting because it will evaluate the first blood-only minimal residual disease (MRD) assay in additional tumor types, and set the stage to identify opportunities for this technology to improve patient care.”\n\nThe study will analyze circulating tumor (ctDNA) status from blood samples of patients with early-stage cancer, using the Guardant Reveal test after the end of treatment, and during routine follow-up. Participants will be followed until distant recurrence, or up to five years. The ORACLE study adds to currently underway clinical studies (COBRA, ACT-3, PEGASUS) evaluating the performance of the Guardant Reveal blood test in patients with early-stage cancer.\n\n“Initiating this study adds to the growing body of evidence that will support the expansion of the Guardant Reveal blood test from its first indication of early-stage colorectal cancer to multiple cancer types. We believe our blood-only test can be a powerful and streamlined decision-making tool for oncologists managing patients with early-stage cancers,” said Helmy Eltoukhy, Guardant Health Co-CEO. “The ORACLE study exemplifies our commitment to further demonstrating the utility of our blood tests to improve long-term clinical outcomes.”\n\nThe Guardant Reveal test is the first blood-only liquid biopsy test that detects residual and recurrent disease from a simple blood draw. The test detects ctDNA in blood after surgery, to identify patients with residual disease who may benefit most from adjuvant therapy, and to detect recurr...