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Guardant Health Initiates ECLIPSE Pivotal Study for its LUNAR-2 Blood Test for Colorectal Cancer Screening
Prospective Study Expected to Enroll 10,000 Average-Risk Patients to Assess Performance of Blood Test for Early Detection of Colorectal Cancer REDWOOD CITY,
About this update from Guardant Health, Inc.
[{"type":"text","content":"Prospective Study Expected to Enroll 10,000 Average-Risk Patients to Assess Performance of Blood Test for Early Detection of Colorectal Cancer\nREDWOOD CITY, Calif., Oct. 23, 2019 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq: GH) has initiated the ECLIPSE trial, a 10,000-patient registrational study to evaluate the performance of its LUNAR-2 blood test to detect colorectal cancer (CRC) in average-risk adults. The test is intended to improve CRC screening rates by offering a simpler blood test that overcomes barriers associated with current testing methods.\n\n \n \n \n \n \n \n \n \n \n \n \n President & COO\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n Chief Executive Officer\n \n \n \n \n \n \n \n \n\n The U.S. Preventive Services Task Force recommends screening average-risk adults for colorectal cancer starting at age 50 and then regularly thereafter.1 Current screening methods are time consuming and additionally in the case of colonoscopy, invasive. Despite the availability of testing options, one-third of adults in the U.S. are not up-to date even though regular screening for colorectal cancer has been shown to improve survival.2,3 “Colorectal cancer screening is known to be effective in saving lives. Unfortunately, one-third of adults do not adhere to national screening recommendations. Because blood tests are a routine part of a patient’s office visit, we believe our blood test could be easily integrated into an already established workflow which will lead to significantly increased screening rates,” said Guardant Health President AmirAli Talasaz, PhD. “We are excited about the performance of the LUNAR-2 assay and look forward to the results of this large prospective study to drive both payer coverage and clinical adoption.” The ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Encounter) trial is a prospective, multi-site registrational study. It is expected to enroll approximately 10,000 individuals aged 45-84 who are at average risk for colorectal cancer. The primary objective is to evaluate the performance of the company’s LUNAR-2 blood test to detect colorectal cancer in a screen-relevant population. If successful, Guardant expects data from the trial will support a premarket approval (PMA) submission to the FDA. Recent data showed that Guardant’s multi-dimensional approach to analyzing s...