Guardant Health, Inc. Presents Data At 2021 ASCO Annual Meeting Showing Blood Test Highly Accurate in Detecting Colorectal Cancer in Patients with Early-Stage Cancer
June 04, 2021 at 09:10 am EDT
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Guardant Health, Inc. presented new data at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting being held from June 4-June 8, 2021, showing that its LUNAR-2 blood test is a highly sensitive test that can detect colorectal cancer (CRC) in early-stage cancer patients. This large ever cohort continues to demonstrate the performance and robustness of the LUNAR-2 assay. It is estimated that only 68% of adults, 50 years and older, are screened for CRC despite the Centers of Disease Control (CDC) target compliance goal of 80%.3-5 A patient-friendly blood testing option with high sensitivity could finally bridge the gap to this compliance goal, and bend the mortality curve for the second leading cause of cancer death in the U.S. The data (N=705) show that the LUNAR-2 assay achieved overall sensitivity of 91% in early-stage CRC (stage I, II, and III), and specificity of 94%. The performance in this new cohort of CRC cases, and cancer-free controls, is consistent with previously reported data.1-2 Notably, no differences in sensitivity for CRC detection were observed in patients presenting with asymptomatic disease, compared to those patients who were symptomatic, despite the lower cell-free DNA (cfDNA) tumor fractions observed in asymptomatic patients, suggesting the test will have clinically meaningful performance in an average-risk screening population. Further, an expanded multi-cohort analysis of over 1,300 cases of patients with CRC, demonstrated that the LUNAR-2 assay consistently delivers clinical meaningful sensitivity for the detection of early-stage cancer. The LUNAR-2 assay achieves industry-leading performance for detecting early-stage CRC by simultaneously interrogating somatic, methylation, and fragmentomic signals from circulating tumor DNA (ctDNA) in the blood. The ECLIPSE trial, a 10,000-patient registrational study, is currently underway to evaluate the performance of LUNAR-2 to detect CRC in an average-risk adult population. If successful, Guardant Health expects data from the trial will support a premarket approval (PMA) submission to the FDA. The trial is expected to complete enrollment by the end of 2021.
Guardant Health, Inc. is a precision oncology company focused on guarding wellness and giving every person more time free from cancer. It provides critical insights into what drives disease through its advanced blood and tissue tests, real-world data, and artificial intelligence (AI) analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and helping doctors select the best treatment for patients with advanced cancer. For patients with advanced-stage cancer, it has developed Guardant360 laboratory developed test (LDT), and Guardant360 CDx, a comprehensive liquid biopsy test to provide tumor mutation profiling with solid tumors and to be used as a companion diagnostic in connection with non-small cell lung cancer (NSCLC), and breast cancer. It offers other tests, including Guardant360 TissueNext tissue test, Guardant Reveal blood test, Guardant360 Response blood test and others.
Guardant Health, Inc. Presents Data At 2021 ASCO Annual Meeting Showing Blood Test Highly Accurate in Detecting Colorectal Cancer in Patients with Early-Stage Cancer