Gen-Probe Prostate Cancer Test Looks Promising

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that a positive PCA3 was a more reliable indicator of cancer than a positive PSA. Seventy-eight percent of men with positive PCA3 results had cancer versus 21 percent of men with positive PSA scores.

The study confirmed the PCA3 has a high-false negative rate, which is why it is not seen as a replacement for the PSA. Just 49 percent of men with a negative PCA3 were cancer-free versus 87 percent of men with negative PSA scores.

As I previously reported, the PCA3 test detects genetic material from the PCA3 gene, which is 65 times more common in prostate cancer cells than normal cells.

Gen-Probe has completed enrollment in a 500-patient pivotal study that will determine whether the PCA3 test can reliably predict which men need a second biopsy following a first negative biopsy and positive PSA result. The company expects to have the results in time to submit a marketing application for the device to the FDA in the third quarter, Watts said. The test, which is available in Europe, could reach the U.S. market in 2011.

Denise Gellene is a former Los Angeles Times science writer and regular contributor to Xconomy. You can reach her at dgellene@xconomy.com Follow @

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