On June 4, 2021 Guardant Health, Inc. (Nasdaq: GH) reported that presents new data at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 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 (Press release, Guardant Health, JUN 4, 2021, View Source [SID1234583594]). This largest ever cohort continues to demonstrate the performance and robustness of the LUNAR-2 assay.1,2
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Today, 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.6
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.
"It’s exciting to see the latest data on Guardant Health’s LUNAR-2 assay, which are consistent with prior data, but most importantly deliver the performance necessary for clinical adoption in average-risk colorectal cancer screening," said Jeeyun Lee, MD, Professor, Division of Hematology/Oncology, Samsung Medical Center. "It’s great to see the momentum Guardant Health has achieved since the introduction of their best-in-class liquid biopsy technology in 2014. Now, they are at the precipice of delivering a highly sensitive colorectal cancer screening test, and I look forward to seeing the outcome of their registrational study."
"What makes this data particularly exciting is that our LUNAR-2 assay continues to show clinically meaningful performance in increasingly larger cohorts of patients with early-stage cancer," said Helmy Eltoukhy, Guardant Health CEO. "Furthermore, our assay delivered comparable sensitivity in both asymptomatic and symptomatic patients, despite the significantly reduced signals in asymptomatic patients. We’re pleased with the test performance which exceeds the benchmark required for clinical adoption in an average-risk patient population."
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.