title: APTIMA PCA3 molecular urine test: development of a method to aid in the diagnosis of prostate cancer.
abstract: BACKGROUND
  Prostate cancer gene 3 (PCA3) encodes a prostate-specific mRNA that has shown promise as a prostate cancer diagnostic tool. This report describes the characterization of a prototype quantitative PCA3-based test for whole urine.
  
  
  METHODS
  Whole-urine specimens were collected after digital rectal examination from 3 groups: men scheduled for prostate biopsy (n = 70), healthy men (<45 years of age with no known prostate cancer risk factors; n = 52), and men who had undergone radical prostatectomy (n = 21). PCA3 and prostate-specific antigen (PSA) mRNAs were isolated, amplified, and quantified by use of Gen-Probe DTS400 Systems. Prostate biopsy results were correlated with the PCA3/PSA mRNA ratio, and PSA mRNA concentrations were used to normalize PCA3 signals and confirm the yield of prostate-specific RNA. Assay precision, specimen stability, and mRNA yield were also evaluated.
  
  
  RESULTS
  The specimen informative rate (fraction of specimens yielding sufficient RNA for analysis) was 98.2%. In this clinical research study, ROC curve analysis of prebiopsy specimens yielded an area under the curve of 0.746; sensitivity was 69% and specificity 79%. Serum PSA assay specificity was 28% for this same group. PCA3 and PSA mRNAs were undetectable in postprostatectomy specimens except for one man with recurrent prostate cancer. Assay interrun CVs were < or =12%. Both mRNAs were stable in processed urine up to 5 days at 4 degrees C and after 5 freeze-thaw cycles.
  
  
  CONCLUSIONS
  The APTIMA PCA3 assay combines simple specimen processing with precise assays and existing instruments and could add specificity to the current algorithm for prostate cancer diagnosis.
authors.affiliation: Gen-Probe Incorporated, San Diego, CA 92121, USA. jackg@gen-probe.com
authors.forename: Jack
authors.initials: J
authors.lastname: Groskopf
authors.forename: Sheila M J
authors.initials: SM
authors.lastname: Aubin
authors.forename: Ina Lim
authors.initials: IL
authors.lastname: Deras
authors.forename: Amy
authors.initials: A
authors.lastname: Blase
authors.forename: Sharon
authors.initials: S
authors.lastname: Bodrug
authors.forename: Craig
authors.initials: C
authors.lastname: Clark
authors.forename: Steven
authors.initials: S
authors.lastname: Brentano
authors.forename: Jeannette
authors.initials: J
authors.lastname: Mathis
authors.forename: Jimmykim
authors.initials: J
authors.lastname: Pham
authors.forename: Troels
authors.initials: T
authors.lastname: Meyer
authors.forename: Michelle
authors.initials: M
authors.lastname: Cass
authors.forename: Petrea
authors.initials: P
authors.lastname: Hodge
authors.forename: Maria Luz
authors.initials: ML
authors.lastname: Macairan
authors.forename: Leonard S
authors.initials: LS
authors.lastname: Marks
authors.forename: Harry
authors.initials: H
authors.lastname: Rittenhouse
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000951:Antigens, Neoplasm / Q000235:genetics* / Q000652:urine*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000235:genetics / Q000652:urine; D011471:Prostatic Neoplasms / Q000175:diagnosis*; D020871:RNA Stability; D012333:RNA, Messenger / Q000652:urine; D012372:ROC Curve; D012680:Sensitivity and Specificity; D013048:Specimen Handling
chemical_list: D000951:Antigens, Neoplasm; D012333:RNA, Messenger; C479341:prostate cancer antigen 3, human; D017430:Prostate-Specific Antigen