Health Discovery Corporation has announced an advance in prostate cancer testing. They claim to have Phase III data supporting the use of a genomic test to diagnose prostate cancer in negative prostate cancer biopsies. The problem is this: even if a man has a negative prostate biopsy (let's say for an elevated PSA) he has a 30% chance of having prostate cancer. We know this. My father-in-law for example has had a negative prostate biopsy a PSA of 7 and a strong chance of having prostate cancer. He refuses to have another prostate biopsy and I can't say I blame him. So here comes Health Discovery Corporation claiming to have a test that is 95% sensitive--in other words it would only miss 5% of prostate cancers that are present on biopsy. This is a strong claim because 5% false-negative is better than 30% false-negative rate. Sure if you go to the trouble to have a prostate biopsy you want to be sure negative is really negative. The problem is that Health Discovery is proposing that we do testing on the 75% of prostate biopsies that are negative in hopes of finding the extra 1/3 of these that are really positive. The screening skeptics which made a loud noise this week with the USPSTF screening guidelines (which isn't even a new message from them) would not be very happy with this new test since it doesn't solve the problem of prostate cancer overdiagnosis; it only exacerbates it. The underlying problem is that we don't have good ways of screening for death and metastasis from prostate cancer which is really what we care about. The vast majority of prostate cancer sufferers will not die of their disease but they will suffer morbidity over biopsies surgery radiation treatment and hormonal therapy for prostate cancer. The risks the skeptics say outweigh the benefits. I trained under a prominent prostate cancer screening skeptic Dr. Otis Brawley. Dr. Brawley is now Chief Medical Director of the American Cancer Society. We have tried to develop predictive markers for prognosis in prostate cancer. I was hoping that this new technology would shed some light on the clinical behavior of prostate cancer but it looks like it will fall short of this. The company claims to be in the process of writing papers and preparing presentations but I'll believe it when I see it. Think about this: the rate of prostate biopsy in Medicare benificiaries is 2 360 per 100 000. With 26 million people on Medicare that means Medicare paid for 306 000 prostate biopsies. If 75% of these are negative this means Healthcare Discovery is anticipating 230 000 samples a year. If they price their test at $2 000 per test we are looking at potentially $460 000 000 per year. Is this company publicly traded? (Yes it is HDVY market cap $13 million). Myriad--this is your takeover target. Forget the drug testing business. Surely someone in Salt Lake City has $13 million to spare? So while this new prostate cancer test looks to make prostate biopsies more informative (and costly) we are still left with the much larger problem of understanding the behavior of prostate cancer.