Brady Investigators Help Gain FDA approval for Two New Tests for Prostate Cancer
For all the good PSA has done, and all the lives it has saved by allowing prostate cancer to be diagnosed years earlier than it would be if men had to rely on a rectal exam alone, this simple blood test has plenty of detractors. Most vocal among them are on the panel (which did not include a single urologist) that made up the United States Preventive Task Force, which recently recommended against PSA screening for prostate cancer. The Task Force also called for more research into finding another biomarker.
Thanks to Brady investigators, there are two more such tests soon to be on the market. Prostate Health Index (phi), a blood test, and PCA3, a urine test, "have been under development for nearly a decade and recently achieved the coveted nod from the Food and Drug Administration for approval," says Alan Partin, M.D., Ph.D., Director of the Brady Urological Institute. Partin and investigators Lori Sokoll, Daniel Chan, Robin Gurganus, and Leslie Mangold, along with other Brady urologists, clinical chemists, nurses, and lab technicians, took part in multi-institutional clinical trials for both tests.
"Our Brady Biomarker Team was responsible for collection and analysis of more than 500 of the nearly 1,600 men who enrolled into these two FDA trials," says Partin. The results of both were positive, "and this means that both phi and PCA3 did a better job of predicting prostate cancer than the PSA test alone. Phi best predicted the presence of prostate cancer among men who had never undergone a biopsy, and PCA3 provided excellent ‘negative predictive' value among men who had previously undergone a biopsy, but continued to have a risk for cancer. We should very soon see these markers available commercially."
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