New Blood Test Helps You Avoid Unnecessary Prostate Cancer Biopsies

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.

Read the original article here on the Cleveland Clinic Health Hub.

Study Confirms 4Kscore Accurately Predicts High-Grade Prostate Cancer

A blood test called the 4Kscore results in accurate detection of high-grade prostate cancer. In a prospective study of 1,012 men, this test more accurately predicted the presence of high-grade disease compared with a commonly used risk calculator in men with elevated prostate-specific antigen (PSA) levels.

The results from this study (Abstract 1) were presented by Sanoj Punnen, MD, a urologic oncologist at the University of Miami in Florida at the 2015 Genitourinary Cancers Symposium.

In this study, men scheduled for a prostate biopsy were enrolled, regardless of their PSA level or clinical findings, at 26 centers across the United States between October 2013 and April 2014. A total of 231 (23%) high-grade prostate cancers were detected. The 4Kscore showed a higher net benefit in comparison with the PCPTRC at all threshold possibilities for high-grade disease used in clinical practice.

The test is able to detect aggressive prostate cancer with high accuracy, Punnen told Cancer Network. “The area under the curve is better than any other biomarker in this area. There was a significant reduction in biopsies that could be attained if we used this test,” he said.

The goal of the 4Kscore is to reduce unnecessary biopsies, as the vast majority of biopsies show either no cancer or a low-grade tumor. These biopsies result in high medical costs, as well as morbidities for the patient.

The 4Kscore was able to better discriminate high-grade vs low-grade prostate cancer compared with the Prostate Cancer Prevention Trial Risk Calculator (PCPTRC) (area under the curve of 0.82 vs 0.74; P < .0001).

The commercially available test is made by OPKO Health, Inc., a Florida-based pharmaceutical and diagnostics company, and is manufactured by a Clinical Laboratory Improvement Amendments–accredited facility. The test uses four blood-based measures: total PSA, free PSA, intact PSA, and human kallikrein 2 (hK2). These results are combined along with a patient’s age, digital rectal exam results, and history of a prior negative biopsy into a single algorithm. The result, according to OPKO, is a patient-specific probability for finding a high-grade tumor on biopsy, defined by a Gleason score of 7 or higher.

Several European studies, including the European Randomized Study of Screening for Prostate Cancer (ERSPC), showed that the 4Kscore could be used to tell the difference between a low-grade tumor and an aggressive, high-grade tumor.

Read the original article at:

OPKO’s 4Kscore Prostate Biopsy Alternative Might Reduce Unnecessary Biopsies

ORLANDO—The 4Kscore, an algorithmic analysis of data from a blood test that combines four kallikrein assays with clinical information to identify the probability of high-grade prostate tumors, could dramatically reduce the number of unnecessary prostate biopsies, according to a multi-institutional prospective study (Abstract 1) presented during the 2015 Genitourinary Cancers Symposium.1

“The 4Kscore demonstrated excellent accuracy in detecting high-grade prostate cancer,” reported lead study author Sanoj Punnen, MD, of the Sylvestor Comprehensive Cancer Center and Department of Urology, University of Miami in Miami, FL. “It is a useful tool in selecting men who are likely to have high-grade disease and most likely to benefit from a prostate biopsy versus those men with no cancer or indolent cancer.”

Prostate cancer screening is associated with improved cancer-specific mortality “but comes at a high cost,” Dr. Punnen noted. “Saving one man’s life requires that 1,068 men be screened and 48 undergo treatment…. Many men will have to undergo unnecessary testing,” he said. “Biopsy entails significant risks of urinary incontinence and emotional stress.”

The 4Kscore has been “well validated in multiple retrospective European cohorts,” Dr. Punnen reported, but it has not previously been tested prospectively or in the United States.

Read the entire article on Cancer Therapy Advisor.

New Test Reducing The Number Of Invasive Prostate Biopsies

MIAMI (CBSMiami) – Every year more than one million men have a prostate biopsy, an invasive procedure that involves needles. It turns out a majority of those biopsies reveal if a patient has no prostate cancer or low risk for cancer.

In an effort to reduce the number of invasive biopsies, UM Sylvester Comprehensive Cancer Center is introducing a new method in cancer screening. It’s a new tool called “4Kscore.”


Dr. Dipen Parekh, Chair of Department of Urology at University of Miami, is the lead author of the first U.S. clinical trial of the 4Kscore. The screening requires only a blood test.

Dr. Parekh says three-out-of-four men are unnecessarily subjected to the invasive procedure every year.

With this new blood test revealing an individual’s 4Kscore, in combination with some other clinical parameters, patients can get their individualized percentage risk for high risk prostate cancer.

“We found that [the 4KScore] has 80 percent chance of accurately predicting high grade prostate cancer,” said Dr. Parekh. “And, if you use several cut offs of the 4KScore, you can almost lead to reduction of 50-60 percent of unnecessary biopsies.”

It is not an easy subject to talk about, but it is a necessary and in some cases life-saving one.

Victor Franks works in the healthcare industry and understands the need for more conversation.

“Women will talk about breast cancer all day long, but men aren’t going to talk about prostate cancer,” said Franks. “It’s a specter that hangs over men as much as breast cancer with women.”

Doctors recommend that men over 40 get regular prostate exams. That’s a digital rectal examination performed by a doctor. If something suspicious is found, a prostate biopsy is ordered – during which a needle is inserted in the rectum.

“You have it done once. You really don’t want to do it again,” said Norwood Davis who has undergone a prostate biopsy before. “It was one of the most unpleasant experiences I’ve ever had.”

Davis’ biopsy turned out nothing, but at 75 years old he was scheduled for a second one. This time he was introduced to UM Sylvester Comprehensive Cancer Center and the 4Kscore.

He said he was ordered to give blood and his tests revealed he had no reason for another biopsy.

“It’s close to a miracle for guys,” said Davis.

Dr. Parekh said as a doctor his goal is to preserve the quality of his patent’s lives. He added there is a sense of relief and reassurance both for the patient as well as the treating physician.

“What we are doing in our practice now is that as soon as a man is referred to us for a biopsy with an elevated PSA, we are using the 4Kscore to determine whether or not that individual needs biopsy or not. It’s not a knee jerk automatic reaction,” said Dr. Parekh.

The reduction in the number of biopsies performed could potentially add up to $1 billion in savings for the U.S. health care system.

While the 4Kscore is not FDA-approved, it is used under FDA guidelines. The good news is that the 4Kscore is covered by some insurance providers.

See original article on CBS Miami.

OPKO Health CEO Dr. Frost Discusses BioReference Labs Acquisition, Impact of 4Kscore Test with Jim Cramer on Mad Money

OPKO Health CEO Dr. Phillip Frost visited Jim Cramer on Mad Money September 25, 2015, to explain the recent acquisition of Bio-Reference Laboratories and the impact it expects to have on our overall business.

As Dr. Frost explained:

“This is probably the best, and most interesting acquisition I have ever made.  First of all we realized a 14% dilution in our equity with this acquistion, what did we get?  We got a billion dollars in revenue, approximately a hundred million dollars in operating income, and we have access to a salesforce and infrastructure that will help make our 4Kscore test one of the most important tests in the history of the diagnostics business.  It has that potential.” 

In August of 2015, OPKO Health, Inc. (NYSE: OPK) and Bio-Reference Laboratories, Inc. (NASDAQ: BRLI) announced the completion of the acquisition of Bio-Reference by OPKO. Shareholders of Bio-Reference received 2.75 shares of OPKO common stock for each share of Bio-Reference common stock.