- The Washington Times - Thursday, April 27, 2006

A new test that combines multiple scientific disciplines can predict accurately which men are either at high or low risk for a return of cancer after surgical removal of the prostate gland.

The test, known as Prostate PX, is the first and only diagnostic test that combines cellular, molecular and clinical information about a patient with advanced computer technology and digital imaging to deliver the patient’s individual risk for a recurrence of cancer.

Produced by Aureon Laboratories of Yonkers, N.Y., Prostate PX was approved by the U.S. Food and Drug Administration in February and gradually is being marketed around the country.

“Prostate cancer is the most diagnosed cancer in U.S. men, with about 230,000 diagnoses yearly. Of those, 90,000 to 100,000 men undergo a prostatectomy, or surgical removal of the prostate,” said Rob Shovlyn, vice president of sales and marketing for Aureon Laboratories.

About 15 percent of post-prostatectomy patients experience a return of cancer. But, until now, it has been difficult for doctors to identify patients who fall into this high-risk category.

Overall, about 30,000 American men die of prostate cancer annually. It follows lung cancer as the second biggest cancer killer of men.

Dr. James Eastham, associate attending physician in the Department of Urology at Memorial Sloan-Kettering Cancer Center in New York, who is familiar with Prostate PX, said he thinks the new test will “benefit about 20 percent of patients currently operated on.”

“The patients most likely to benefit are those deemed to be at a higher rate of recurrence by currently available tools, since this test can hone in on just how high a risk such a patient faces. It won’t benefit those at low risk, since it would not be cost-effective,” Dr. Eastham said in a telephone interview.

The new test — priced at $1,968 — is based on an analysis of a small section of a patient’s excised prostate collected from the pathology department of the hospital where he had it removed. The pathology department sends it to Aureon Labs, so there is no need for the patient to make additional laboratory visits or undergo post-surgical needle-sticks.

In clinical trials, Prostate PX accurately predicted a return of prostate cancer in 94 percent of patients who experienced recurrence within five years. Moreover, it accurately predicted clinical failure — or a distant spread of the cancer — in 89 percent of post-prostatectomy patients who developed metastasis five years after surgery, said Jason Alter, a spokesman for Aureon Labs.

Linking the clinical data together, the test comes up with what is known as the Prostate PX score. Post-operative patients with a score ranging from zero to just under 40 are determined to be at low risk. Those with higher scores of up to 100 are viewed as being at high risk.

At this time, Prostate PX is primarily being sold in the Northeast. But it should be available nationally by mid-2007, according to Mr. Shovlyn.

“The test is going to help, but it is still not the magic bullet,” said Dr. Brad Lerner, chief of the Department of Urology at Union Memorial Hospital in Baltimore.

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