SAN DIEGO, May 12, 2020 /PRNewswire/ -- Singlera Genomics completed their second Pre-Submission Meeting with the US FDA Center for Devices and Radiological Health, Office of In Vitro Diagnostics on April 21, 2020, after an initial Pre-Submission Meeting in the fall of 2019. The FDA provided clear guidance on the regulatory pathway and clinical trial plan for Singlera Genomics ColonES® assay.
Singlera Genomics is developing the ColonES® assay as a non-invasive, blood-based screening assay for the early detection of colorectal cancer. ColonES® assay only requires a small amount of blood to capture the circulating tumor DNA (ctDNA) methylation signal in the blood. The assay is based on the methylation characteristics of free ctDNA and uses high-throughput next generation sequencing technology to screen for colorectal cancer (CRC) and precancerous lesions (advanced adenoma). Preliminary data suggests the ColonES® assay may have significant advantages over existing stool-based technologies regarding sensitivity and specificity of CRC, as patients view blood-based assays more favorably than stool-based samples.
Yuan (Gary) Gao, PhD, Co-founder and Chairman of the Board for Singlera Genomics stated, "we are very pleased with the outcome of the FDA meeting and look forward to validating our retrospective study that provides a high sensitivity and specificity on early colorectal cancer and advanced adenoma patients." Dr. Gao also said that ColonES® as "the only blood based non-invasive test that can detect early adenoma would help to save millions lives from colorectal cancers after it gets FDA's approval and launch to market."
Singlera plans to start the ColonES® pivotal study in the United States in the second half of 2020 and has recruited over 100 clinical study sites to participate. Singlera Genomics is also leveraging their novel technology platform to study the early detection of other human cancers.
Singlera Genomics Inc. (www.singlera.com)
Singlera Genomics Inc., a company focusing on non-invasive genetic diagnosis, was co-founded in July 2014 in San Diego, California by Yuan Gao, PhD, Professor Kun Zhang (University of California at San Diego), Mr. Jiangli Zhang (CEO), Mr. Qiang Liu (COO), and Dr. Rui Liu (CTO). The company currently has R&D centers and business operations in both La Jolla, California, and Shanghai, China. Singlera has proprietary technologies in single cell sequencing, DNA methylation and bioinformatics.
Singlera Genomics is committed to the application of next generation sequencing to diagnose genetic diseases and disorders. Singlera Genomics develops non-invasive genetic tests using proprietary technologies including single cell sequencing, DNA methylation sequencing and machine learning. Singlera Genomics' products address the continuing needs for early-stage cancer detection, personalized cancer treatment, prenatal diagnosis, and pre-implantation genetic screening. Additionally, Singlera Genomics provides customized next generation sequencing services to pharmaceutical companies and medical research institutions. It has operation centers in the United States and China.
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