COMPOSITE ASSAY FOR DETECTING A CLINICAL CONDITION
The invention generally relates to methods for screening patients for one or more clinical conditions using a composite assay. According to certain aspects, methods of the invention involve isolating at least one nucleic acid from a biological sample obtained from the subject, detecting at least one sequence mutation and a chromosomal abnormality in the at least one nucleic acid in a single assay format, and identifying a clinical condition in said subject when both the sequence mutation and the chromosomal abnormality are present.
1 . A method for detection a clinical condition in a subject, said method comprising the steps of:
isolating at least one nucleic acid from a biological sample obtained from the subject;
detecting at least one sequence mutation and a chromosomal abnormality in the at least one nucleic acid in a single assay format; and
identifying a clinical condition in said subject when both the sequence mutation and the chromosomal abnormality are present.
2 . The method of claim 1 , wherein the at least one nucleic acid is DNA.
3 . The method of claim 2 , wherein the DNA is genomic DNA.
4 . The method of claim 1 , wherein the sequence mutation and chromosomal abnormality occur on the same chromosome.
5 . The method of claim 1 , wherein the sequence mutation and the chromosomal abnormality occur on different chromosomes.
6 . The method of claim 1 , wherein the sequence mutation is a point mutation.
7 . The method of claim 1 , wherein the chromosomal abnormality is loss of heterozygosity.
8 . The method of claim 1 , wherein the clinical condition is cancer.
9 . The method of claim 8 , wherein the cancer is bladder cancer.
10 . The method of claim 1 , wherein the detecting step further comprises detecting a chemical modification to the nucleic acid.
11 . The method of claim 10 , wherein the chemical modification to the nucleic acid comprises hypermethylation.
12 . The method of claim 1 , wherein the single assay format comprises a nucleic acid sequencing technique.
13 . The method of claim 12 , wherein the sequencing technique is a single molecule sequencing technique.
14 . The method of claim 1 , wherein a sequence mutation in FGFR3 is detected.
15 . The method of claim 1 , wherein a chromosomal abnormality in p53 is detected.
16 . The method of claim 15 , wherein the chromosomal abnormality is loss of heterzygosity.