Opko Health Inc (OPK)

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4Kscore Test Represents a Major Step in The Right Direction, says Andrew Stephenson, MD

New Blood Test Helps You Avoid Unnecessary Prostate Cancer Biopsies

Can be used in conjunction with PSA blood test

By Urinary & Kidney Team | 5/6/15 9:00 a.m.

A new screening tool for prostate cancer has been shown to offer better accuracy than the test currently used by most physicians in the United States. The new test, called the 4Kscore™ test (OPKO Lab), offers various advantages over the more commonly used prostate specific antigen (PSA) blood test.

The new test improves on these common issues with the PSA blood test:

>Isn’t specific to cancer; detects a variety of prostate issues
>Doesn’t account for a natural tendency for PSA levels to rise with age

These factors increase the PSA blood test’s false positive results, says Andrew Stephenson, MD, Director of the Center of Urologic Oncology at Cleveland Clinic’s Glickman Urological and Kidney Institute. They are the reason why many men go on to have a prostate biopsy when they don’t really need one.

Avoiding unnecessary biopsies

Biopsies are unpleasant for patients. Also, they carry a small risk of infection and bleeding. Sometimes, they detect cancers that are minor and that do not need treatment. Still, when patients learn about these minor cancers, it can cause them needless stress, Dr. Stephenson says.

“The promise of the new 4Kscore test is that it is more specific for prostate cancer. It appears to identify patients at risk for high-grade cancers more efficiently than the PSA,” he says.

Best way to use the new test

Dr. Stephenson says the best way to use the new test is not as a replacement of the PSA test. Rather, it is to use the new test as a follow-up to a positive PSA test, but before undergoing a biopsy. Using it this way, physicians can reduce the need for prostate biopsy by 30 to 50 percent. Doctors at Cleveland Clinic have already started using the new test.

The test’s performance is quite good across many patient populations, Dr. Stephenson says. There is no one type of patient who benefits more than others.

According to 4Kscore’s manufacturer, the test has undergone extensive clinical review. The company cites more than a decade of research involving more than 20,000 men in Europe and the United States.

Filling a need

There has been a clear need for a more accurate prostate cancer screening tool. Considering the impact of false-positive PSA results, experts have been dubious about the overall benefits of the blood test.

“The paradigm that we have used to screen patients for prostate cancer has needed to change for a while,” Dr. Stephenson says. “The U.S. Preventive Service Task Force gave PSA screening a grade of D in 2012. They said the harm it brings outweighs the benefits. The 4Kscore test represents a major step in the right direction. It improves our prostate cancer screening practices.”

The new 4Kscore test can help patients avoid unnecessary worry and procedures while accurately identifying when there is a real need for treatment, he says.