RARE CELL ANALYSIS USING SAMPLE SPLITTING AND DNA TAGS
First Claim
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1. A method for diagnosing or prognosing cancer in a patient comprising:
- splitting a rare cell-enriched biological sample, obtained at a time point from said patient, into a plurality of subsamples; and
performing a molecular analysis or a morphological analysis on one or more subsamples in said plurality of subsamples, wherein ten percent or more of the total number of cells in at least one of said one or more subsamples are rare cells, and a cancer diagnosis or prognosis for said patient is determined based on said molecular analysis or said morphological analysis.
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Abstract
Described herein are methods to diagnose or prognose cancer in a subject by enriching, detecting, and analyzing individual rare cells, e.g., epithelial cells, in a sample from the subject. Also described are methods for labeling regions of genomic DNA in individual cells in said mixed sample with different labels wherein each label is specific to each cell and quantifying the labeled regions of genomic DNA from each cell in the mixed sample. More particularly the method includes detecting the presence of gene mutations in individual rare cells in a subsample.
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Citations
56 Claims
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1. A method for diagnosing or prognosing cancer in a patient comprising:
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splitting a rare cell-enriched biological sample, obtained at a time point from said patient, into a plurality of subsamples; and
performing a molecular analysis or a morphological analysis on one or more subsamples in said plurality of subsamples, wherein ten percent or more of the total number of cells in at least one of said one or more subsamples are rare cells, and a cancer diagnosis or prognosis for said patient is determined based on said molecular analysis or said morphological analysis. - 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)
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25. A method for diagnosing or prognosing cancer in a patient comprising:
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(i) enriching a biological sample, obtained at a time point from said patient, for rare cells to obtain a rare cell-enriched biological sample;
(ii) splitting said rare cell-enriched biological sample obtained from said patient at a time point into a plurality of subsamples; and
(iii) performing a molecular analysis or a morphological analysis on one or more subsamples in said plurality of subsamples, wherein ten percent or more of the total number of cells in at least one of said one or more subsamples are rare cells, and a cancer diagnosis or prognosis for said patient is determined based on said molecular analysis or said morphological analysis. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43)
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44. The method of claim 87, wherein said amplifying is followed by quantitative genotyping.
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45. The method of claim 91, wherein said quantitative genotyping is performed using one or more molecular inversion probes.
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46. A method of optimizing a cancer therapy for a patient, said method comprising:
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(i) splitting a rare cell-enriched biological sample, obtained from said patient at a time point, into a plurality of subsamples containing one or more rare cells;
(ii) performing a molecular analysis on one or more subsamples of said plurality of subsamples; and
(iii) based on said molecular analysis;
(a) predicting efficacy of a cancer therapy treatment for said patient;
(b) selecting said cancer therapy treatment for said patient;
or(c) excluding said cancer therapy treatment for said patient;
wherein(i) said molecular analysis includes determining the presence or absence of a gene mutation in said one or more subsamples, (ii) ten percent or more of the total number of cells in at least one of said one or more subsamples are rare cells, and (iii) a cancer diagnosis or prognosis for said patient is determined based on said molecular analysis. - View Dependent Claims (47, 48, 49, 50, 51, 52, 53, 54, 55, 56)
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Specification