Thomas Jefferson University in Philadelphia has received a patent for a molecular-based blood test that provides a novel approach to diagnosing prostate cancer. Jefferson has given exclusive licensing rights to the test to UroCor, Inc., for the United States and Canada, and to the Italian-based biotechnology firm Raggio-Italgene, for Europe and Japan.
The new test is the result of research conducted at Jefferson demonstrating that prostate cancer metastasis could be detected in the blood of some patients with prostate cancer. The molecular test may offer a new method of assessing the extent of prostate cancer by detecting prostate cells in the blood. These cells produce prostatic-specific antigen (PSA) and may originate from a prostate tumor. Using the molecular biology technique called reverse transcriptase polymerase chain reaction (rt/PCR), 1 cancer cell in 100 million cells may be found using a simple blood sample.
The rt/PCR test can determine whether prostate cells have migrated beyond the prostate, suggesting an advanced stage of disease. Ongoing research at other cancer centers has demonstrated that this test may also be able to determine advanced stages of prostate cancer long before such methods as x-rays show that the cancer has spread. One role of the new blood test may be to direct treatment options for advanced prostate cancer. If the blood test shows the cancer has spread, the patient could be given the option of hormonal therapy or newer, experimental therapy, as opposed to surgical removal of the prostate.
Early Stages of Development
"This test is in its infancy and the exact role of rt/PCR in the patient with prostate cancer remains to be clearly defined in our ongoing multi-center trial," said Leonard G. Gomella, md, director of urologic oncology at Jefferson's Kimmel Cancer Center. Dr. Gomella is working in conjunction with other Jefferson researchers, including Jose G. Moreno, md, and Carlo Croce, md, director of the Kimmel Cancer Center, in the development of this test. Eight academic cancer centers across the United States, in concert with UroCor, are currently studying how to best apply this new blood test to patients with prostate cancer.
"Men with prostate cancer die because it spreads through the bloodstream to their bones. This test gives us a powerful tool to determine when spreading of the cancer first occurs," said Dr. Gomella.
"Simply removing the prostate in those patients often is an ineffective way to treat the disease," he said. "Combining the diagnosis with the power of the new rt/PCR test will help to define the best treatment approach."
The patent is the result of work by Jefferson researchers on the blood assay begun several years ago. Abram Goldfinger, director of technology transfer at Jefferson, believes that the patent serves as confirmation of the pioneering work in this field led by Jefferson researchers. "We look forward to these advances at Jefferson becoming widely available to provide improved patient care."