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    TEST:
    PDACatch assay

    Company:
    Singlera Genomics
    Type:
    Laboratory Developed Test
    Details
    Evidence

    News

    8ms
    Cross-platform comparisons for targeted bisulfite sequencing of MGISEQ-2000 and NovaSeq6000. (PubMed, Clin Epigenetics)
    Taken together, MGISEQ-2000 demonstrated similar data quality, consistency of the methylation levels, comparable analytic sensitivity, and matching clinical performance, supporting its application in future non-invasive early cancer detection investigations by detecting distinct methylation patterns of cfDNAs.
    Journal
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    PDACatch assay
    12ms
    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
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    PDACatch assay