Validation of a real-time PCR-based qualitative assay for the detection of methylated SEPT9 DNA in human plasma.

@article{Potter2014ValidationOA,
  title={Validation of a real-time PCR-based qualitative assay for the detection of methylated SEPT9 DNA in human plasma.},
  author={Nicholas T. Potter and Patrick Hurban and Mary N. White and Kara D Whitlock and Catherine E. Lofton-Day and Reimo Tetzner and Thomas Koenig and Neil B. Quigley and Gunter Weiss},
  journal={Clinical chemistry},
  year={2014},
  volume={60 9},
  pages={
          1183-91
        }
}
  • Nicholas T. Potter, Patrick Hurban, +6 authors Gunter Weiss
  • Published in Clinical chemistry 2014
  • Medicine
  • BACKGROUND Epi proColon® is a new blood-based colorectal cancer (CRC) screening test designed to determine the methylation status of a promoter region of the SEPT9 (septin 9) gene in cell-free DNA isolated from plasma. We describe the analytical and clinical performance of the test. METHODS Analytical performance at 4 testing laboratories included determination of limit of detection, precision, and reproducibility of the SEPT9 test. Clinical performance was evaluated in a prospective study by… CONTINUE READING

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