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Singlera Genomics

Other names: Singlera Genomics
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Singlera Genomics Receives FDA Breakthrough Device Designation for PDACatch, a Liquid Biopsy Assay for Pancreatic Cancer Detection in High-Risk Individuals (PRNewswire)
"Singlera Genomics...announced that it had received Breakthrough Device Designation from the Food and Drug Administration (FDA) for its PDACatch assay, a novel DNA methylation-based liquid biopsy assay for the detection of pancreatic adenocarcinoma in individuals at high risk for the disease...Singlera Genomics is in the process of launching a prospective study and clinical trial to further evaluate and obtain pre-market approval for the PDACatch assay."
Breakthrough therapy designation • FDA event
PDACatch assay