Assay for prostate cancer
OwnerSteven Smith, Jarrod Clark +1inventors
InventorsSteven Smith, Jarrod Clark, Kristofer Munson
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Abstract
In certain embodiments, a method for detecting a prostate proliferative cell disorder, a prostate cancer or a prostate tumor and/or categorizing Gleason's Sum of the tumors includes performing a digital rectal examination on a subject; obtaining one or more expressed prostatic secretion (EPS) samples from the subject; measuring PSA levels in the EPS; and measuring a biomarker, wherein the biomarker is TMPRSS2:ERG fusion RNA. Optionally, the biomarker may be methylated copies of GSTPI, APC, RARB and/or RASSFI DNA or PCA3 RNA. A kit for performing any of the above embodiments is also contemplated.
Claims16
1-32. (canceled)
A method of diagnosing a prostate cell proliferative disorder by detecting one or more preselected methylation biomarker in a subject comprising:
- obtaining a biological sample from the subject;
- isolating DNA from the sample;
- contacting the isolated DNA or fragment thereof with one or more methylation-sensitive reagent, wherein the treated DNA is optionally PCR amplified;
- and
- determining the presence of one or a combination of methylation biomarker sequences selected from the group consisting of:
- PSA RNA;
- TMPRSS2:ERG RNA;
- GSTPI, APC, RARB, RASSFI DNA;
- TMPRSS2:ERG Type III or VI fusion RNA;
- GSTPI, APC, RARB, RASSFI and PCA3.
A method of detecting a prostate cell proliferative disorder in a subject comprising:
- (a) obtaining one or more expressed prostatic secretion (EPS) sample from the subject;
- (b) measuring serum prostate specific antigen (PSA) levels in the EPS sample of the subject;
- and
- (c) measuring the level of one or more biomarkers from the EPS sample, said biomarkers selected from the group consisting of:
- i) PSA RNA;
- ii) TMPRSS2:ERG RNA;
- iii) copy number of GSTP1 APC, RARβ, or RASSF1 DNA;
- iv) TMPRSS2:ERG Type III or VI fusion RNA;
- and
- v) methylated copies of GSTP1, APC, RARβ, PCA3, or RASSF1;
- wherein elevated serum PSA levels as compared to normal PSA serum levels and presence of one or more of the biomarkers from the EPS sample indicates that the subject has a prostate cell proliferative disease.
A method of detecting a prostate proliferative cell disorder in a subject by measuring the level of methylation of a panel of target biomarkers in an expressed prostatic secretion sample obtained from the subject, wherein the target biomarkers are GSTP1, APC, RARβ, and RASSF1, and wherein there is a positive correlation between a ratio of methylated DNA to total methylated and unmethylated DNA for the biomarkers and the presence of a prostate proliferative cell disorder.
Dependencies are inferred from the claim text.