US-based precision oncology company Guardant Health has initiated Evaluation of ctDNA LUNAR Assay in an Average Patient Screening Encounter (ECLIPSE) trial, involving 10,000 patients, to analyse the performance of its LUNAR-2 blood test to detect colorectal cancer (CRC).
The test is designed to boost CRC screening rates in average-risk adults by providing a more straightforward blood test.
According to the recommendation of the US Preventive Services Task Force, the screening of average-risk adults for colorectal cancer should start at the age of 50, and continue regularly.
The present testing methods are not only time-consuming but also invasive, in cases such as colonoscopy.
Though testing options are available, one-third of adults in the country are not up-to-date, despite regular screening for colorectal cancer being shown to improve survival rate.
Guardant Health president AmirAli Talasaz said: “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.
“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 trial is expected to enrol around 10,000 individuals aged between 45 and 84 years, who stand at average risk for colorectal cancer.
The firm expects the data from the trial to support its premarket approval (PMA) submission to the US Food and Drug Administration (FDA).
According to the recent data, the company’s multi-dimensional strategy to analyse genomic, epigenomic, somatic and fragmentomic signals from circulating tumour DNA in the blood was found to be effective in detecting early stage colorectal cancer.
Guardant Health CEO Helmy Eltoukhy said: “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.
“We believe it is an ideal disease to address first because the low compliance of current approaches creates a clear unmet medical need, the tumour 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. Initiating this study marks a major step forward in our mission of conquering cancer with data.”