New lab test market could open up if research findings lead to a useful clinical laboratory test that predicts prostate cancer recurrence
Over the past decade, clinical laboratory tests that can predict the occurrence or recurrence of breast cancer have opened up a profitable market for the companies that developed these technologies. Now, new research may become the basis of a useful medical laboratory test that could be predictive of prostate cancer relapse.
Of course, pathologists know that several years of further development and regulatory approvals will be needed before this research produces a lab test for clinical use that can reliably predict the recurrence of prostate cancer. What makes this development exciting is that there is a huge and untapped demand to help men with prostate cancer and their physicians make informed decisions about treatment options and long-term prognosis.
Pathologists Were Part of the UPCM Research Team
This pioneering work was done by a research team of pathologists, biostatisticians, and urologists at the University of Pittsburgh School of Medicine (UPSM). They compared genetic abnormalities in various types of tissue to predict whether and how rapidly prostate cancer would relapse after treatment. The scientists compared particular amplifications and deletions, as well as the size of copy number variations (CNV) in cancer tissue, benign tissue, and blood. They were then able to build a prediction model to determine which patients would relapse and the rapidity of relapse.
These findings were published online in The American Journal of Pathology. The UPMC research team showed that genetic abnormalities in malignant and benign prostate tissue are predictive of prostate cancer relapse.
“Our analysis indicates that CNV [copy-number variation] occurred in both cancer and non-cancer tissues, and CNV of these tissues predicts prostate cancer progression,” stated Jian-Hua Luo, M.D., Ph.D., Associate Professor, Divisions of Molecular and Cellular Pathology, and Anatomic Molecular Pathology, Department of Pathology, UPSM, in a press release.
Luo was lead investigator on the research. “Prediction models of prostate cancer relapse, or of the rate of PSA level increase after surgery, were generated from specific CNV patterns in tumor or benign prostate tissues adjacent to cancer samples,” he noted.
Science May Lead to New Pathology Test
Applying the prediction model to prostate cancer tissue, the researchers at UPMC correctly predicted 73% of relapses and 75% of cases with a rapid relapse time, or short prostate-specific antigen (PSA) doubling time (PSADT) reported PubMed Health. Looking at healthy tissue, the model accurately predicted relapse 67% of the time and rapid relapse 77% of the time.
With the blood samples, the researchers looked at the size of the copy-number variation. They observed that the size of variations in prostate cancer patients who relapsed was significantly higher. When used on blood samples, the prediction model predicted relapse with 81% accuracy. It predicted rapid relapse with 69% accuracy.
To conduct the research, the scientists looked at samples of blood, prostate tumors, and healthy prostate tissue from 238 patients who had undergone radical prostatectomies. They compared genetic differences to the different outcomes the men experienced.
Luo observed that the use of CNV for testing offers several potential clinical applications. It holds the promise of a more efficient and accurate way to predict the behavior of prostate cancer. It also can inform decisions as to whether additional treatment is warranted to prevent relapse. ”For a patient diagnosed with prostate cancer, CNV analysis done on blood or normal tissues would eliminate the need for additional invasive procedures to decide a treatment mode,” he stated in the eurekalert release.
As it applies to prostate cancer, the CNV test still has limitations. For example, it requires high-quality genome DNA. This can make the test expensive and difficult to perform. PubMed also pointed out that larger clinical trials must be conducted before the new technique can be used as a test. PubMed further noted that researchers will need to the false positive rate and the false negative rate.
Prostate Cancer Market Is Ripe for Right Clinical Lab Test
According to the National Cancer Institute, prostate cancer is the second leading cause of cancer death in men. For 2012, the organization anticipates over 240,000 new cases of prostate cancer and over 28,000 deaths from the disease in the United States.
According to figures published at marketwatch.com, surveyed U.S. oncologists indicate they would prescribe Medivation/Astellas Pharma’s Enzalutamide to 30 percent of their second- and third-line metastatic castrate-resistant prostate cancer (mCRPC) patients. The prostate cancer drug market will more than double over the next decade. It is expected to increase from $3.6 billion in 2010 to more than $9 billion in 2020 in the U.S., France, Germany, Italy, Spain, the United Kingdom, and Japan.
That means that when this medical laboratory test is ready for widespread clinical use, there will be strong demand. Pathologists and clinical laboratory managers can expect to see additional types of assays for detecting prostate cancer emerge from other research settings.
One holy grail in testing for prostate cancer is a method that identifies aggressive versus slow-growth forms of prostate cancer. Biotech investors understand that an accurate test capable of this type of diagnosis would be a revenue home run. That is why any number of biotech companies and research labs are working on solving this problem.
—Pamela Scherer McLeod