Guardant Health announced it has initiated the ECLIPSE trial, a 10,000-patient registrational trial to evaluate the efficacy of its LUNAR-2 blood test to detect colorectal cancer (CRC) in average-risk adults.
“Colorectal cancer screening is known to be effective in saving lives. Unfortunately, one-third of adults do not adhere to national screening recommendations, said Guardant Health President AmirAli Talasaz, Ph.D., in a press release. “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.”
The ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Encounter) trial is a prospective, multi-site registrational study. The goal for the trial is enroll 10,000 individuals aged 45-84 who are at average risk for colorectal cancer, with the objective of evaluating how well Guardant’s LUNAR-2 blood test detects CRC in this population.
According to Guardant, recent data showed that the company’s multi-dimensional approach to analyzing somatic genomic, epigenomic, and fragmentomic signals from circulating tumor DNA in the blood was effective in detecting colorectal cancer in the early stages.
If the ECLIPSE trial is successful, Guardant anticipates the data developed from the trial will support a premarket approval submission to the FDA.
“The LUNAR-2 assay has shown high sensitivity in detecting colorectal cancer and we are ready to make this our first indication for the early detection of cancer in asymptomatic individuals,” said Guardant Health CEO Helmy Eltoukhy, Ph.D. “We believe it is an ideal disease to address first, because the low compliance of current approaches creates a clear unmet medical need, the tumor biology is well captured by our blood-based technology and existing pathways are in place for both downstream intervention and reimbursement, making it easier to drive clinical use.”