Method for monitoring disease progression or recurrence
First Claim
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1. A method for monitoring disappearance, regression, progression or recurrence of diseased tissue in a patient, the method comprising the steps of:
- obtaining a first heterogeneous biological sample from the patient;
generating a patient-specific genetic profile of diseased tissue by interrogating a plurality of genomic loci in genomic DNA and/or free DNA isolated from the first heterogeneous biological sample obtained from the patient for the presence and/or the amount of a plurality of biomarkers, wherein(i) the plurality of genomic loci comprises at least one mutation in each of K-ras, adenomatous polyposis coli (APC), p53, and PIK3CA, and(ii) the presence of at least one mutation at an individual locus is indicative of the presence of diseased tissue; and
initiating a treatment protocol after the first heterogeneous biological sample is obtained;
obtaining a second heterogeneous biological sample from said patient after treatment; and
monitoring the patient-specific genetic profile by interrogating the plurality of genomic loci in genomic DNA and/or free DNA isolated from the second heterogeneous biological sample for the presence and/or the amount of the plurality of biomarkers, wherein a change of the patient-specific genetic profile is indicative of the disappearance, regression, progression or recurrence of the diseased tissue in the patient.
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Abstract
The invention provides methods for detecting and monitoring diseases associated with genetic abnormalities in a subject.
194 Citations
39 Claims
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1. A method for monitoring disappearance, regression, progression or recurrence of diseased tissue in a patient, the method comprising the steps of:
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obtaining a first heterogeneous biological sample from the patient; generating a patient-specific genetic profile of diseased tissue by interrogating a plurality of genomic loci in genomic DNA and/or free DNA isolated from the first heterogeneous biological sample obtained from the patient for the presence and/or the amount of a plurality of biomarkers, wherein (i) the plurality of genomic loci comprises at least one mutation in each of K-ras, adenomatous polyposis coli (APC), p53, and PIK3CA, and (ii) the presence of at least one mutation at an individual locus is indicative of the presence of diseased tissue; and initiating a treatment protocol after the first heterogeneous biological sample is obtained; obtaining a second heterogeneous biological sample from said patient after treatment; and monitoring the patient-specific genetic profile by interrogating the plurality of genomic loci in genomic DNA and/or free DNA isolated from the second heterogeneous biological sample for the presence and/or the amount of the plurality of biomarkers, wherein a change of the patient-specific genetic profile is indicative of the disappearance, regression, progression or recurrence of the diseased tissue in the patient. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37)
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38. A method for monitoring disappearance, regression, progression or recurrence of diseased tissue in a patient, the method comprising the steps of:
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generating a patient-specific genetic profile of diseased tissue by interrogating a plurality of genomic loci in genomic DNA and/or free DNA isolated from a biological sample obtained from the patient for the presence and/or the amount of a plurality of biomarkers, wherein (i) the plurality of genomic loci comprises at least one mutation in each of K-ras, adenomatous polyposis coli (APC), p53, and PIK3CA, and (ii) the presence of at least one mutation at an individual locus is indicative of the presence of diseased tissue; and monitoring the patient-specific genetic profile by interrogating the plurality of genomic loci in genomic DNA and/or free DNA isolated from a second heterogeneous biological sample for the presence and/or the amount of the plurality of biomarkers, wherein a change of the patient-specific genetic profile is indicative of the disappearance, regression, progression or recurrence of the diseased tissue in the patient. - View Dependent Claims (39)
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Specification