Patent attributes
Methods, kits and compositions drawn related to providing controls in diagnostic testing are provided. In one embodiment, a method of verifying proper function of a test for detecting and/or classifying a disease or disorder for which manifestation of a methylated gene is a biomarker is provided. The method includes performing a test for detecting, monitoring, or classifying a disease or disorder, or predisposition thereto, for which manifestation of a methylated gene is a biomarker and verifying proper function of the test by performing (e.g. duplicating or repeating) the test utilizing a control that originates from at least one pregnant female animal. The test includes determining the methylation status of at least one biomarker from a biological sample obtained from an animal subject and verifying proper function of the test by performing the test utilizing a control that originates from at least one pregnant female animal.
