On October 5, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that it 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 (Press release, Guardant Health, OCT 5, 2021, View Source [SID1234590848]).
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"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."
The 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.
"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."
The 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 recurrence months earlier than current standard-of-care methods.1-6 The commercially available test achieves high sensitivity (91%)7 for detecting ctDNA by simultaneously interrogating both genomic alterations and methylation. The first indication of the test is colorectal cancer, with additional cancer types to follow.
More details about the ORACLE study can be found at NCT05059444.