Gene Expression Test for Prostate Cancer Promises More Accurate Diagnoses

The burgeoning world of biomarkers, focused mainly on women’s health issues and particularly breast cancer, has now moved into prostate cancer, the number one cancer in men with an estimated 200,000 new cases diagnosed annually in the U.S. alone. Clarient (Nasdaq: CLRT,, a smallcap company based in Aliso Viejo, CA, announced this month it has launched a new gene expression diagnostic for prostate cancer based on a patented combination of four genes that can accurately identify the presence of prostate cancer cells, which until now has proven to be a very imprecise science. The Clarient press release announcing the launch ( noted that, out of more than 1 million prostate cancer tissue biopsies done annually in the U.S., one-third of the men reported as negative for prostate cancer actually do have prostate cancer that was missed by the biopsy. The Clarient test accurately identified the presence of Grade 3 or higher prostate cancer 90 percent of the time in a clinical validation study.

Other smallcap companies involved in prostate cancer treatment include Endocare (Nasdaq: ENDO,, a California-based medical device company that develops minimally invasive ablation techniques including cryoablation, which freezes a tumor to destroy it and is used for kidney, lung and other cancers including prostate cancer; and IsoRay (AMEX: ISR,, a Washington-based company that develops isotope-based seeds for brachtherapy for prostate cancer but is developing new brachytherapy seeds for other cancers including breast cancer.


3 thoughts on “Gene Expression Test for Prostate Cancer Promises More Accurate Diagnoses

  1. Pingback: Gene Expression Test for Prostate Cancer Promises More Accurate Diagnoses · Prostate Cancer

    • Jan: Not it is not based on pca3gen expression. Here is an explanation:
      A Four-Gene Signature for Prostate Cancer
      Cells: UAP1, PDLIM5, IMPDH2, and HSPD1
      Isabelle Guyon+, Herbert A. Fritsche++,
      Paul Choppa**, and Stephen D. Barnhill+
      + Health Discovery Corporation, Savannah, Georgia
      ++ University of Texas M.D. Anderson Cancer Center , Houston, Texas
      ** Clarient Inc., Aliso Viejo, California
      We have developed and validated a molecular signature consisting of four genes to assist in the
      tissue diagnosis of prostate cancer. The discovery database consisted of Affymetrix microarray
      (U133A) data generated from 87 prostate tissues that were carefully laser micro-dissected to give
      cell types reflecting the anatomic zones of the prostate and Gleason grade 3 and 4 cancer. Using
      support vector machine algorithms, we identified a set of genes overexpresssed in prostate
      cancer. The gene discovery was confirmed with a data set consisting of 164 independently
      collected and analyzed samples from the Oncomine repository. Using the discovery gene set we
      developed a unique molecular signature by combining four complementary genes that gave an
      AUC = 0.94 (area under the ROC curve) for discrimination of non-cancer from prostate cancer
      cells. The 4-gene diagnostic signature was validated with 71 independent samples, including
      both fresh prostate tissues and formalin fixed tissues, using reverse transcriptase polymerase
      chain reaction (RT-PCR) giving both high sensitivity and specificity (at 90% sensitivity, the
      specificity = 97% , with a 95% CI = 86% – 100%) . The 4-gene RT-PCR test can be used to
      detect Gleason grade 3 and 4 cancer cells in prostate biopsy tissue

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