Differential methylation level of cpg loci that are determinative of a biochemical reoccurrence of prostate cancer
AssigneesHudsonAlpha Institute for Biotechnology, The Board of Directors of the Leland Stanford Junior University
InventorsRichard M. Myers, James D. Brooks, Marie K. Kirby
Life of this patent
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Abstract
The present disclosure provides for and relates to the identification of novel biomarkers for diagnosis and prognosis of prostate cancer or the biochemical reoccurrence of prostate cancer. The biomarkers of the invention show altered methylation levels of certain CpG loci relative to normal prostate tissue, as set forth.
Claims14
A method for determining the presence or absence of the biochemical reoccurrence of prostate cancer in an individual, the method comprising:
- a. identifying an individual who has undergone a previous treatment for prostate cancer, wherein said previous treatment comprises a radical prostatectomy, and may be in need of treatment of the biochemical reoccurrence of prostate cancer;
- b. obtaining a sample of bodily fluid from the individual and isolating the DNA therefrom;
- c. contacting the isolated DNA with sodium bisulfate;
- d. determining the methylation level of at least one cytosine within a DNA region in a sample from the individual where the DNA region is at least 90% identical to SEQ ID NO:
- 2, wherein said determining step comprises performing a molecular assay to determine the methylation level of the at least one cytosine, wherein said determining of the methylation level of the at least one cytosine also comprises contacting the DNA region with a primer that hybridizes to the DNA region;
- and
- e. comparing the methylation level of the at least one cytosine to a threshold value for the at least one cytosine, wherein the threshold value distinguishes between individuals with and without a biochemical reoccurrence of prostate cancer, wherein the comparison of the methylation level to the threshold value is predictive of the presence or absence a biochemical reoccurrence of prostate cancer in the individual;
- and
- f. administering a treatment to the individual if the biochemical reoccurrence of prostate cancer is indicated after the comparing.
The method of claim 8 further comprising determining the methylation level of cytosine in at least two of SEQ ID NOS:
- 1 and 3-32.
A kit useful for the determination of the biochemical reoccurrence of prostate cancer, the kit comprising
- wherein the biomarker is a polynucleotide of the sequence of SEQ ID. NO. 2, and the kit comprises:
- a. a sample collection kit for obtaining a biological sample from an individual;
- b. reagents and materials for isolating DNA from a sample obtained by using the sample collection kit;
- c. sodium bisulfite for contacting the isolated DNA;
- d. a primer that is capable of amplifying the sequence of SEQ ID NO. 2;
- and
- e. at least one container for housing the aforementioned materials and/or instructions for use of the kit for determining status of a biochemical occurrence of prostate cancer in the individual by determining the methylation level of at least one cytosine in SEQ ID NO. 2 after contacting the isolated DNA with the sodium bisulfite.
Dependencies are inferred from the claim text.