Patent ID: 9512477
Filing Date: 2016-12-06
CPC Classification: C12Q

Claim Text:
1. A method of characterizing a biomarker in a sample, the method comprising: providing a sample comprising a wild-type nucleic acid and a corresponding mutant nucleic acid that is a biomarker for a disease; introducing a plurality of positive controls to the sample, the plurality of positive controls comprising a sequence identical to the mutant nucleic acid and a unique control sequence comprising a number of degenerate bases; amplifying the mutant nucleic acid and the plurality of positive controls in the sample; loading the amplified nucleic acid sample and the plurality of positive controls on a separation medium, the separation medium comprising an immobilized probe, the immobilized probe comprising a nucleic acid sequence complementary to the mutant nucleic acid; enriching the amplified nucleic acid sample for the mutant nucleic acid and the plurality of positive controls over the wild type nucleic acid by applying a time-varying driving field and a time-varying mobility-varying field to the separation medium; characterizing the enriched nucleic acid in the sample with a technique selected from nucleic acid sequencing, quantitative PCR (qPCR), mass spectrometry, and hybridization assay; and quantifying abundance of the mutant nucleic acid in the provided sample using the plurality of positive controls.