Methods for detecting gene dysregulation by intragenic differential expression
AssigneeQuest Diagnostics Investments Incorporated
InventorsHeather R. Sanders, Maher Albitar, Aurelia Meloni-Ehrig
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Abstract
Described herein are methods, compositions and kits directed to the detection of gene dysregulations such as those arising from gene fusions and/or chromosomal abnormalities, e.g., translocations, insertions, inversions and deletions. Samples containing dysregulated gene(s) of interest may show independent expression patterns for the 5′ and 3′ regions of the gene. The methods, compositions and kits are useful for detecting mutations that cause the differential expression of a 5′ portion of a target gene relative to the 3′ region of the target gene.
Claims13
A method for distinguishing prostate cancer from benign prostate hyperplasia in a subject suspected of having prostate cancer comprising:
- (a) amplifying a 5′ region of a TMPRSS2 gene transcript, in a biological sample from the subject with one or more 5′ target primer pairs which are complementary to the 5′ region of the TMPRSS2 gene;
- (b) amplifying a 3′ region of the TMPRSS2 gene transcript, if present, in the biological sample with one or more 3′ target primer pairs which are complementary to the 3′ region of the TMPRSS2 gene;
- (c) detecting the amounts of amplification products produced by the one or more 5′ target primer pairs and the one or more 3′ target primer pairs;
- and
- (d) diagnosing the subject as having prostate cancer when the relative expression level of the 5′ region to the 3′ region of the TMPRSS2 gene is above a cutoff level, and diagnosing the subject as having benign prostate hyperplasia when the relative expression level of the 5′ region to the 3′ region of the TMPRSS2 gene is below the cutoff level.
Dependencies are inferred from the claim text.