title: Minimally invasive prostate cancer detection test using FISH probes.
abstract: OBJECTIVE
  The ability to test for and detect prostate cancer with minimal invasiveness has the potential to reduce unnecessary prostate biopsies. This study was conducted as part of a clinical investigation for the development of an OligoFISH(®) probe panel for more accurate detection of prostate cancer.
  
  
  METHODS
  One hundred eligible male patients undergoing transrectal ultrasound biopsies were enrolled in the study. After undergoing digital rectal examination with pressure, voided urine was collected in sufficient volume to prepare at least two slides using ThinPrep. Probe panels were tested on the slides, and 500 cells were scored when possible. From the 100 patients recruited, 85 had more than 300 cells scored and were included in the clinical performance calculations.
  
  
  RESULTS
  Chromosomes Y, 7, 10, 20, 6, 8, 16, and 18 were polysomic in most prostate carcinoma cases. Of these eight chromosomes, chromosomes 7, 16, 18, and 20 were identified as having the highest clinical performance as a fluorescence in situ hybridization test and used to manufacture the fluorescence in situ hybridization probe panels. The OligoFISH(®) probes performed with 100% analytical specificity. When the OligoFISH(®) probes were compared with the biopsy results for each individual, the test results highly correlated with positive and negative prostate biopsy pathology findings, supporting their high specificity and accuracy. Probes for chromosomes 7, 16, 18, and 20 showed in the receiver operator characteristics analysis an area under the curve of 0.83, with an accuracy of 81% in predicting the biopsy result.
  
  
  CONCLUSIONS
  This investigation demonstrates the ease of use with high specificity, high predictive value, and accuracy in identifying prostate cancer in voided urine after digital rectal examination with pressure. The test is likely to have positive impact on clinical practice and advance approaches to the detection of prostate cancer. Further evaluation is warranted.
authors.affiliation: Pathology and Research Department, Michigan Institute of Urology, St Clair Shores, MI, USA.
authors.forename: Rima
authors.initials: R
authors.lastname: Tinawi-Aljundi
authors.affiliation: Research and Development, Cellay, Inc., Cambridge, MA, USA.
authors.forename: Shannon T
authors.initials: ST
authors.lastname: Knuth
authors.affiliation: Research and Development, Cellay, Inc., Cambridge, MA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Gildea
authors.affiliation: Research and Development, Cellay, Inc., Cambridge, MA, USA.
authors.forename: Joshua
authors.initials: J
authors.lastname: Khal
authors.affiliation: Pathology and Research Department, Michigan Institute of Urology, St Clair Shores, MI, USA.
authors.forename: Jason
authors.initials: J
authors.lastname: Hafron
authors.affiliation: Pathology and Research Department, Michigan Institute of Urology, St Clair Shores, MI, USA.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Kernen
authors.affiliation: Pathology and Research Department, Michigan Institute of Urology, St Clair Shores, MI, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Di Loreto
authors.affiliation: Research and Development, Cellay, Inc., Cambridge, MA, USA.
authors.forename: Joan
authors.initials: J
authors.lastname: Aurich-Costa
keywords: OligoFISH®; PSA screening; oncology; prostate cancer detection