A Better Prostate Cancer Test Is Here

Monday, 31 Mar 2014 08:18 AM

By Steve Plamann

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Until recently, the PSA test for prostate cancer had been a routine part of every middle age man’s physical. But it has fallen out of favor as doctors realized the PSA was leading many men to have needless and painful prostate biopsies and unnecessary cancer treatments.

In fact, major medical groups have stopped recommending routine PSA testing for most men.

But now a better prostate cancer test has become available to help address the problem.

It’s called the 4Kscore Test. Instead of testing for only one biomarker of prostate cancer as the PSA test does, the 4Kscore tests for four biomarkers and adds a man’s age, his digital rectal exam result, and whether or not he has had a prior prostate biopsy to come up with his score. The 4Kscore is a man’s probability for having life-threatening prostate cancer, and allows their doctors to add this to the PSA and other clinical information to gauge whether a prostate biopsy is necessary.

“Our clinical data demonstrated that the 4Kscore could help to reduce unnecessary biopsies by providing more accurate information on the probability of high-grade prostate cancer,” said David Okrongly, president of OPKO Diagnostics (NYSE: OPK), the maker of the test.

“It will offer both the urologist and the patient better information to make a more informed decision about having a prostate biopsy.”

Currently, about 80 percent of prostate biopsies ultimately prove to be unnecessary because they are either negative for cancer or show a low-grade disease that is no threat to health. Besides being painful, biopsies carry a significant risk of bleeding and infection.

Like the PSA test, the 4Kscore test involves a simple blood draw. It was developed by OPKO, a leading biopharmaceutical and diagnostics company, based upon research performed at Memorial Sloan Kettering Cancer Center in New York and research centers in Europe where more than 10,000 men have been studied with the test.

Prostate cancer is the second most deadly cancer in American men according to the National Cancer Institute. In 2014, some 29,480 men are projected to die from the disease and some 233,000 more will be diagnosed with it.

Okrongly notes that “over 1 million biopsies will be performed in the US in 2014, and with better information, that number could be significantly reduced to the benefit of the patient and the overall cost of healthcare.”

The test is available for the first time starting today, March 31. Men who think they may be candidates for the 4Kscore should have their doctor contact OPKO through its website
(www.opko.com).

The cost of test is $395 and the company expects that it will be covered by insurance within 12 to 18 months after launch.

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