Prostate cancer methylation assay

A technology for prostate cancer and hypermethylation, applied in the field of prostate cancer methylation analysis, can solve the problems of large number of biopsies and low detection specificity

Inactive Publication Date: 2012-01-04
VERIDEX LCC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Poor specificity of PSA testing has been shown to result in large numbers of patients being biopsied unnecessarily and often limits screenable PSA to patients >4 ng / mL

Method used

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  • Prostate cancer methylation assay

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Embodiment Construction

[0007] Hypermethylation assays including detection of GSTP, APC, and RARβ2 markers are described, for example, in US Patent Publication 20080254455, which is hereby incorporated by reference. These assays have now been improved and can be combined with other diagnostic and risk factor indicators.

[0008] In a study of a cohort of 337 apparently healthy men with no previous history of prostate cancer, urine samples were obtained from 9 different urology clinical sites. Urine samples (up to 40 mL) were collected after the prescribed DRE, which involved indenting the prostate surface 0.5 to 1.0 cm and moving from base to apex and laterally to the midline, a minimum of three times per lobe. Transfer the contents of the urine collection container into a 50 mL transport tube filled with 800 μL of 0.5M EDTA. The tubes were stored at 2-8°C for a maximum of three days after collection and shipped overnight with standard ice packs.

[0009] Upon receipt, the transport tubes were imme...

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Abstract

An assay for diagnosing or prognosticating prostate cancer incorporates the detection of hypermethylation of GSTP, APC, and RARss2 genes and may be incorporated into a nomogram.

Description

Background technique [0001] This patent application claims the benefit of US Provisional Application No. 61 / 086,218, filed August 5, 2008. [0002] Serum prostate-specific antigen (PSA) is currently the surveillance standard for prostate cancer screening. Poor specificity of PSA testing has been shown to result in large numbers of patients being biopsied unnecessarily and often limits the screenable PSA range to patients >4 ng / mL. [0003] The new assay uses methylation-specific PCR (MSP) to measure CpG island methylation (epigenetic modification) within the promoter regions of three markers (GSTP1, RARβ2, and APC) that can indicate the presence of prostate cancer. The assay has been evaluated with 337 post-DRE urine samples (187 cancer and atypical samples / 150 non-cancer samples) collected at 9 clinical sites. Patients ranged in age from 40-75 years and had PSA levels ranging from 2 to 10 ng / mL. A sensitivity of 52% and a specificity of 81% for the assay was observed in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/68
CPCC12Q1/6886C12Q2600/154C12Q2600/16C12Q2600/118
Inventor J·F·巴登G·A·格林J·帕恩特S·W·曹Y·王
Owner VERIDEX LCC
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