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Digital Amplification

  • US 20110201004A1
  • Filed: 03/24/2011
  • Published: 08/18/2011
  • Est. Priority Date: 08/02/1999
  • Status: Active Grant
First Claim
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1. A method for detecting a cancer-associated mutant nucleic acid that is present in a patient sample at a low level relative to a corresponding wild-type nucleic acid, the method comprising:

  • diluting nucleic acids in a biological sample to form a set comprising a plurality of assay samples;

    amplifying the nucleic acids in the assay samples to form a population of amplified molecules;

    performing an assay on the amplified molecules in each assay sample to determine whether a cancer-associated mutation is present in at least one of the assay samples;

    wherein the step of diluting in performed until at least one-fiftieth of the assay samples in the set comprise a number (N) of molecules such that 1/N is larger than a ratio of the mutant nucleic acid to the wild-type nucleic acid required to detect the mutant nucleic acid if it is present in the assay sample.

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