Singlera Genomics Colon Cancer Assay Pathway

Singlera Genomics says it has completed a pre-submission meeting with CDRH’s Office of In Vitro Diagnostics and it was provided clear guidance on the regulatory pathway and clinical trial plan for the Singlera Genomics ColonES assay. The test is being developed as a blood-based screening assay for the early detection of colorectal cancer. It requires a small amount of blood to capture the circulating tumor DNA methylation signal in the blood, and uses high-throughput next generation sequencing technology to screen for colorectal cancer and precancerous lesions (advanced adenoma). The company says that preliminary data suggest the assay may have significant advantages over existing stool-based technologies regarding sensitivity and specificity. Singlera plans to start the ColonES pivotal study in the U.S. in the second half of 2020 and has recruited over 100 clinical study sites to participate.