This Valentine’s Day, Show Your Loved Ones You Care About Your Health

Valentine’s Day is one of those holidays that comes with a certain amount of trepidation for most of us. The stress of selecting the right gift can take the fun out of the sentiment. However, we might just have the perfect gift idea for the special person in your life; peace of mind for your prostate health with the 4Kscore Test.

Show Them You Care About Your Health

It is not uncommon for men to forgo preventative healthcare services and to avoid medical treatment altogether. In fact, research from the Centers for Disease Control and Prevention (CDC) found that women are 33% more likely than their male counterparts to visit their doctor and 100% more likely to seek preventative services. 1 If your loved one has encouraged you to take a more proactive approach to health screenings, maybe it’s time to listen. This Valentine’s Day, why not show your loved ones just how much you care by getting a 4Kscore Test?

What is the 4Kscore Test?

The 4Kscore is a simple blood test that is performed after an abnormal screening test such as PSA, leveraging cutting edge advances in medical science to determine a patient’s risk for aggressive prostate cancer. The test measures four prostate-specific biomarkers in the blood, which are combined with clinical findings into an algorithm to provide a man’s risk of having aggressive prostate cancer on a scale from <1% to >95%. By getting a simple blood test, you and your special Valentine can rest assured that you are taking an active role in your prostate health.

Who Should get the 4Kscore Test?

The 4Kscore Test is intended for any man after an abnormal PSA or other prostate cancer testing, as a means to provide his risk of high-grade, aggressive prostate cancer before making a biopsy decision. If you have had an abnormal PSA, the 4Kscore can provide the answers you and your loved ones are seeking. Contact your physician, ask the right questions, and get tested at a 4Kscore test laboratory in your area.
Have questions about the 4Kscore test? We encourage you to peruse our website for answers to a wide variety of frequently asked questions, or email us directly at Would you like more tips to help you take an active role in your prostate health? Subscribe to our blog for insights and information throughout the year.


1) Centers for Disease Control and Prevention (CDC). Women more likely than men to visit the doctor, more likely to have annual exams. Available at (Accessed on January 24, 2017).

4Kscore Test: A Clinically Proven Prostate Cancer Test

The 4Kscore accurately provides the risk of aggressive prostate cancer, reducing the number of unnecessary prostate biopsies performed annually. The accuracy of the 4Kscore algorithm to provide the risk of high grade prostate cancer is based on over a decade of research completed by scientists at Memorial Sloan Kettering Cancer Center and other leading international cancer research centers.

4Kscore Test: A Clinically Proven Prostate Cancer Test

The 4Kscore Test has undergone a wide variety of clinical studies in reputable research facilities, in the US and abroad. Some highlights:

  • The 4Kscore was validated in a prospective blinded clinical study conducted at 26 urology centers across the United States on more than 1,012 patients. The 4Kscore demonstrated a near perfect calibration to actual prostate biopsy results, with a significantly higher accuracy than PSA for high grade prostate cancer.1
  • In a landmark case-control study including 12,542 men, the 4Kscore’s ability to predict risk of developing distant metastasis in men with a suspicious PSA for their age was evaluated. Men who had a suspicious PSA and a 4Kscore of 7.5% or less had a very low risk (< 0.3%) of developing distant metastasis within 10 years.2
  • In a retrospective study, where the 4Kscore was provided to 611 patients seen by 35 academic and community urologists across the United States, a reduction in prostate biopsies of 64.6% was reported.  There was a 94% reduction in prostate biopsies in men with a low risk 4Kscore (< 7.5%).3

Additional studies include:

Accurately Identify Risk of Aggressive Prostate Cancer with the 4Kscore

Prostate cancer is the second most common cancer among men, and it is estimated that nearly three million men are living with the disease in the United States. Having the ability to accurately identify a man’s risk of having aggressive prostate cancer not only saves lives but dramatically decreases the number of unnecessary biopsies, which can be both painful and costly.  The 4Kscore Test measures 4 prostate-specific kallikreins in the blood: Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2), which are combined with important clinical findings to provide the risk of aggressive prostate cancer. With  extensive research and validation to back it up, the 4Kscore Test is revolutionizing the way doctors and patients approach prostate cancer diagnosis.

If you would like to learn more about the 4Kscore Test, we encourage you to contact us today or find a laboratory in your area.


  1. A Multi-institutional Prospective Trial in the USA Confirms that the 4Kscore Accurately Identifies Men with High-grade Prostate Cancer. Eur Urol 2014; 68(3):464-470
  2. Improving the Specificity of Screening for Lethal Prostate Cancer Using Prostate-specific Antigen and a Panel of Kallikrein Markers: A Nested Case–Control Study. Eur Urol 2015; 68 (2): 207-213
  3. The 4Kscore® Test Reduces Prostate Biopsy Rates in Community and Academic Urology Practices. Reviews in Urology 2015. 17(4): 231-240


Happy New Year! How Your Resolution Can do More than Trim Your Waistline

Are you resolving to get into shape this New Year? If so, you are not alone. According to a 2015 Nielsen study, 37% of those surveyed listed staying fit and healthy as their New Year’s resolution while 32% were focused on weight loss. [1] As we move into 2017, it is safe to assume that these goals remain among the most common resolutions of the New Year. If you hope to improve your health in the coming months, we applaud you! After all, a healthier lifestyle not only makes you look and feel better, it can reduce your risk factor for a multitude of health problems.

Body Mass and Cancer Risk [2]

The World Cancer Research Fund estimates that roughly 20% of cancers diagnosed each year in the United States are linked to preventable health issues – including excess body fat, lack of physical exercise, excess consumption of alcohol, and/or poor nutrition.  While all of these variables may contribute to one’s cancer risk, excess body weight seems to have the strongest correlation, contributing to as many as 1 in 5 of all cancer-related deaths.

Carrying excess body weight is linked with an increased risk of many types of cancer including breast cancer, endometrium cancer, esophagus cancer, colon and rectum cancer, pancreas cancer, and kidney cancer. In addition, being overweight or obese may potentially raise one’s risk of developing aggressive forms of prostate cancer, gallbladder cancer, non-Hodgkin lymphoma, liver cancer, multiple myeloma cancer, cervix cancer, and ovarian cancer.

Health in the New Year

Studies tells us that carrying excess body fat is not only hard on the heart, it can contribute to your cancer risk factor, being all the more reason to set health goals in 2017 and resolve to stick to them. Carve out time each week to exercise to help you stay fit, and make a conscious effort to eat a diet rich in vitamins and nutrients.

Another factor that can contribute to cancer risk, including prostate cancer risk, is family health history. Don’t miss our recent post to learn more about genetic predispositions for developing cancer. If you or a loved one have reason to believe that you are at an increased risk of prostate cancer, we encourage you to remain vigilant.  By regularly visiting your doctor and undergoing blood tests, you can assess your risk of developing aggressive prostate cancer. The 4Kscore is an advanced blood test that predicts a man’s risk percent of having aggressive prostate cancer in a biopsy on a scale of <1% to >95%.

Setting Your Health Resolutions

As we kick off 2017, we encourage you to resolve to live a healthier lifestyle – not just by trimming your waistline, but also by talking with your family about your health history, visiting your doctor regularly, and reducing your disease risk. And if you’re a man with an elevated PSA, check your risk for aggressive prostate cancer with the 4Kscore test.

Would you like to receive more health tips and insight in the coming year? Subscribe to our blog!

  • This Year’s Top New Year’s Resolution? Fitness!! Available at (Accessed December 11, 2016).
  • American Cancer Society. Does body weight affect cancer risk? Available at (Accessed December 11, 2016)

Home for the Holidays: Family History and Prostate Cancer Risk

For many of us, the holidays are a time to travel home and spend with family and friends. During these joyous occasions, it’s important to reflect on the past and look forward to the future. As you sit down with relatives and share memories, this is also an opportunity to ask questions and have meaningful conversations about your health. Though family health history is a topic that doesn’t always come up, there is no better time to ask questions and learn about your genealogy than when you are gathered together. Knowing your family history can help you understand your risk of developing a wide range of health problems, such as heart disease and certain types of cancer, including cancer of the prostate.

Family Health History and Prostate Cancer

Many studies have demonstrated a genetic contribution to prostate cancer risk. Members of families with the following characteristics may especially want to consider genetic consultation:

  • Having multiple first-degree relatives with a prostate cancer diagnosis
  • Early-onset prostate cancer (age ≤55 years)
  • Those with a family history of prostate cancer along with other types of cancers (e.g., breast, ovarian, pancreatic). [1]

Know Your Family Health History

Research tells us that one’s genetic predisposition for developing cancer reaches beyond cancer of the prostate. In fact, inherited genetic mutations are believed to contribute to 5 to 10 percent of all cancers. [2] This is why it’s important to take the time to discuss family health history when your loved ones are together. Taking a proactive approach can lead to early detection of disease, which can saves lives. We encourage you to ask questions this holiday season – Learn about your family medical history and do your part to educate your relatives about instances of cancer and other disease in your lineage.

4Kscore Test: Simple Prostate Cancer Blood Test

If you or a loved have a family health history of prostate cancer, or other types of cancer, it is important to monitor your health. The 4Kscore checks four prostate-specific biomarkers and clinical information to predict a man’s risk of aggressive prostate cancer. This simple blood test is performed after an abnormal PSA, and can help you and your loved ones specifically determine the risk of aggressive prostate cancer prior to making a prostate biopsy decision. Do your part this holiday season to have the discussion and encourage those you hold dear to take an active role in monitoring their health.

Would you like to receive more insight on the health issues that impact you and your family? Subscribe to our blog.

  • National Cancer Institute. Genetics of Prostate Cancer (PDQ®)–Health Professional Version. Available (Accessed December 8, 2016).
  • National Cancer Institute. Genetic Testing for Hereditary Cancer Syndromes. Available (Accessed December 8, 2016).

This Season, Give the Gift of Information

With so much to consider this time of year, from holiday shopping to social engagements, it’s easy to lose focus of our health. What if you could give a thoughtful gift this year, that shifts focus to your health and that of your loved ones? Rather than getting caught up in the hustle and bustle of holiday commercialism, why not give the men you love peace of mind for their prostate health with information about the 4Kscore.

Peace of Mind for Prostate Health

Prostate cancer risk factors impact us all. Research tells us that 1 in every 7 men will develop some form of prostate cancer in their lifetime. Even if you are not at risk of prostate cancer, chances are someone you love is. This is why we encourage you to share information about the 4Kscore test this season. Whether you choose to have a conversation with your physician about prostate cancer yourself, or you encourage a loved one to do so, you will be giving a gift that doesn’t expire – knowledge about prostate cancer risk and test options.

How Does the 4Kscore Test Work?

If you, or a loved one, have been concerned with prostate health, chances are you are familiar with the PSA test. Unlike the 4Kscore, PSA tests do not clearly differentiate between aggressive prostate cancer and less serious health conditions. Because of this, men with high PSA results may be subjected to unnecessary medical procedures.

The 4Kscore is a follow up test after an abnormal PSA result, and is more specific for aggressive prostate cancer. The 4Kscore combines the values of four prostate-specific kallikreins in the blood (Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2)), with age, digital rectal exam results and prior biopsy history to arrive at a personal risk score for each patient. The resulting 4Kscore predicts a patient’s risk of high grade prostate cancer on a scale from <1% to >95%, and the long-term risk of developing metastatic prostate cancer. The 4Kscore has the potential to dramatically increase the accuracy of prostate cancer diagnosis, and provide men with peace of mind for their prostate health.

Give a Gift that Shows You Care About His Health

If a loved one has an abnormal PSA, the 4Kscore can provide them with peace of mind for their prostate health. This season, give your loved ones the gift of information about their prostate cancer risk and the 4Kscore test. Encourage them to contact their physician, ask the right questions, and get tested at a 4Kscore test laboratory.

Would you like more tips and information on prostate health? Subscribe to our blog for insights and information on the risk factors, diagnosis and prevention of prostate cancer.

The Importance of Staying Fit During the Holidays

For many, the holiday season symbolizes a time to give thanks, spend time with family, and to reflect on the past year. The winter months are also full of indulgence and celebration. While we all try our best to stay on track during the holidays, it is not uncommon to pick-up unhealthy habits while allowing some of our healthier habits to momentarily take a backseat.

Holiday Weight Gain

According to a recent study published in the New England Journal of Medicine, holiday weight gain is an issue in America and abroad. It found that the American participants experienced a 0.2% increase in weight over the Thanksgiving holiday followed by a 0.4% increase over Christmas.  Our German counterparts experienced an increase in body weight by 0.6% over Christmas and an incremental 0.2% over Easter. Finally, Japanese participants saw a 0.5% increase in body weight over Christmas and 0.3% boost over Golden Week, a period which includes four national holidays.[1]

It’s Not Just About the Scale

The ramifications of over indulging and allowing your fitness routine to slip during the holidays can go far beyond a few pounds on the scale or an extra notch on your belt. There are a myriad of health risks associated with sudden weight gain. According to the National Institute of Diabetes and Digestive and Kidney Disease, being overweight can put you at risk of developing type 2 diabetes, high blood pressure, heart disease, certain types of cancer and more.[2]

Physical Activity May Reduce Cancer Risk

The list of benefits of physical activity goes on and on; helping to maintain a healthy weight, producing natural endorphins, fighting heart disease and more. To add to those benefits, research findings have reported a link between regular physical activity and a reduced risk of certain types of cancers.[3] A study completed by a team of researchers at the University of Vermont, Burlington, found that physically fit men, in their midlife, have a reduced risk level of dying of cancer-related deaths as they age.[4] Medical research not only tells us that exercise can reduce the risk of certain types of cancer in men, but that it may also help to keep it at bay. Another study found that regular vigorous physical activity may help to slow the progression of prostate cancer in men age 65 and up.[5]

Battle the Bulge this Holiday Season

Rather than simply allowing yourself to gain a few extra pounds this holiday season, get moving! Make the commitment now to stick to your workout and/or activity routine. Hit the gym a little harder the day before and the day after a major holiday splurge and consider skipping the occasional sweet or cocktail – or opt for healthier food options. By taking a few measures now, you will be doing yourself and your body a lot of favors.

Would you like to receive more tips and insight on living a healthy lifestyle? Subscribe to our blog and follow us on Facebook, Twitter, Google+ and LinkedIn! While you’re here, help us spread the word about the importance of staying fit during the holidays.

Holiday weight gain impacts people worldwide. What are you doing to avoid it in 2016? #BattleTheBulge Click to tweet

A recent study revealed that Americans gain an average of 0.2% body weight over Thanksgiving & 0.4% over Christmas. Don’t be a statistic! Click to tweet

  • New England Journal of Medicine. Weight Gain over the Holidays in Three Countries. Available at (Accessed November 15, 2016).
  • National Institute of Diabetes and Digestive and Kidney Disease. Health Risks of Being Overweight. Available at (Accessed November 16, 2016).
  • National Cancer Institute. Physical Activity and Cancer. Available at (Accessed December 1, 2016)
  • JAMA Oncology. Midlife Cardiorespiratory Fitness, Incident Cancer, and Survival After Cancer in Men. Available at (Accessed December 1, 2016)
  • National Cancer Institute. Physical Activity and Cancer. Available at (Accessed December 1, 2016)

The Fight Against Prostate Cancer: What Men Need to Know

New York, NY – Prostate cancer is the second most common cancer among men, and it is estimated that nearly three million men are living with the disease in the United States. Thankfully, many prostate cancers can be caught early on and either successfully treated or diagnosed as indolent (non-aggressive).

Early detection of prostate cancer begins with screening the Prostate Specific Antigen (PSA) to assess the health of the prostate. All men should get a PSA test, and know their PSA number and what it means. If a PSA test result is high, often times a doctor may recommend a biopsy. However, because the PSA test cannot distinguish between aggressive prostate cancer and other less serious conditions, many men with a high PSA may be subjected to unnecessary prostate biopsies.

The 4Kscore is a simple blood test that bridges the gap between PSA and biopsy, and can help reduce the need for unnecessary biopsies. The 4Kscore combines four prostate-specific proteins results, including PSA, with clinical information in an algorithm that calculates the man’s percent risk for developing aggressive prostate cancer. In some cases, the 4Kscore will show that the patient is at low risk of aggressive disease and does not need a biopsy. In other cases, the 4Kscore will indicate if the patient is at high risk of aggressive disease and provide additional information that can be used in the shared decision between a patient and his physician about whether to proceed with a biopsy.

The 4Kscore is available at BioReference Laboratories and GenPath Diagnostics, OPKO Health Companies, and is utilized by primary care physicians and urologists across the country.

For more information, visit

BioReference Laboratories

BioReference Laboratories, an OPKO Health company, is the third largest full service clinical laboratory in the U.S. providing testing and related services to physician offices, clinics, hospitals, long term care facilities, employers, governmental units and correctional institutions. Our expert division, GenPath Diagnostics, specializes in cancer diagnostics offering a comprehensive cancer patient workup in one laboratory. From special coagulation testing to complex genomic testing for tumor sequencing and hereditary cancer syndromes, the full spectrum of a cancer patient work-up is covered.


Prostate Cancer Awareness Month featured on Hattiesburg American News

For Prostate Cancer Awareness Month, Hattiesburg American News spoke with our client Hattiesburg Clinic Urology about the 4Kscore, a revolutionary test that predicts a man’s risk of developing aggressive prostate cancer. The test assists physicians, urologists, and nurse practitioners in making better-informed patient care decisions. Please read the full article below and see the original post on Hattiesburg American News.

September is Prostate Cancer Awareness Month

Approximately 1 in 7 men will be diagnosed with prostate cancer during his lifetime, according to the American Cancer Society. In 2016, specifically, the ACS estimates 180,890 new cases of prostate cancer will be diagnosed, with more than 26,000 of those resulting in death.

It is statistics like these that drive health care providers like Anne Claire Dugas, CNP, to be proactive when treating patients who could be at risk for the disease. Dugas treats a variety of urological conditions, including prostate cancer, in her role as a certified nurse practitioner at Hattiesburg Clinic Urology.

She said there are new adjunctive testing options their practice uses to determine a patient’s risk for prostate cancer. One of these tests is called the 4Kscore.

“This test is considered one of the most accurate blood tests for predicting aggressive prostate cancer, allowing for better-informed patient care decisions. It helps us to identify men most likely to benefit from prostate biopsy,” said Dugas. “It is a simple blood test, which uses a combination of factors, along with information about the patient, in order to predict the probability of cancer spreading to other parts of the body within 20 years. It helps to reassure patients on prostate biopsy decisions.”

The 4Kscore can be used prior to biopsy or after a negative biopsy. Another test, ConfirmMDx®, is specifically for patients who have received a previous negative biopsy within the last 24 months.

“Sometimes patients have a negative biopsy but continue having concerning symptoms, such as a prostate nodule or continually elevated PSA (prostate-specific antigen). This brings us to the question of when and if another biopsy is appropriate,” Dugas said. “This test can accurately identify two-thirds of men where prostate cancer would be detected in a repeat biopsy. By this same token, it can identify two-thirds of men with no evidence of prostate cancer in a repeat biopsy, allowing them to avoid an unnecessary repeat prostate biopsy.”

She explained, “We are trying to reduce the rate of unnecessary biopsy, and these new tests help us in that area, to try and detect patients with accelerated risk factors.”

Dugas said an important thing to note regarding both these tests is that nothing is 100 percent effective and not every patient will qualify for them. She also pointed out that just because a patient’s PSA is elevated, doesn’t mean a biopsy would even be considered. She said there could be a number of reasons for that.

For those who are diagnosed with the disease, Dugas said there are treatment options available that don’t require surgery.

“Brachytherapy is our typical approach for most patients with prostate cancer, and it is something that many of the doctors at Hattiesburg Clinic Urology use frequently for their patients,” said Dugas.

Brachytherapy is a less invasive alternative to prostate cancer surgery. It is a procedure in which low dose radioactive seeds are implanted into the prostate gland. The seeds slowly release radiation to destroy the cancer.

Some benefits of brachytherapy compared to surgery include a shorter recovery time; no catheterization; less erectile dysfunction; and minimal bleeding.

“The primary advantage of this procedure is that it delivers radiation to a localized area, which minimizes the exposure of radiation to surrounding tissues,” said Dugas.

Hattiesburg Clinic Urology’s board-certified providers offer urological services with a combined approach of clinical experience, technology and accessibility. Services include lithotripsy, laser therapies, laparoscopic surgery, robotic surgery and more. The practice is located at Hattiesburg Clinic’s main campus, 415 S. 28th Ave., on the first floor.

See original article on Hattiesburg American News

Understanding the Risk of Prostate Cancer and How it is Diagnosed

Did you know it’s National Prostate Cancer Awareness Month? What better way to celebrate than to educate yourself about the risks and management of this disease?  The fact of the matter is, one in seven men will be diagnosed with prostate cancer and one in thirty-nine will die from the disease. [1] This month, let’s take the opportunity to learn a bit more about this widespread cancer.

Are You Genetically at a Higher Risk of Developing Prostate Cancer?

While prostate cancer can occur in any male, some members of the population are more susceptible than others. If a man’s father or brother has a previous prostate cancer diagnosis, his risk factor more than doubles. In fact, his risk is even higher if he has several relatives with prostate cancer, particularly if they were diagnosed at a young age. [2]

In addition to family history, ethnicity can also contribute to one’s prostate cancer risk factor. The disease occurs most prevalently in African-American men and Caribbean men of African ancestry. It occurs least often in Asian-American men. [2] Though the reason behind these ethnic differences is unclear, it is important to note that all men have an inherent risk and should therefore be vigilant.

How is Prostate Cancer Diagnosed?

Prostate cancer is evaluated through regular checkups with your physician, generally by PSA screening and/or digital rectal examination.  This may be followed with more specific tests, including a prostate biopsy. Prostate cancers are not all the same, with some being more dangerous than others. The Gleason score grades prostate cancer, with a maximum value of ten.  A higher score indicates a higher risk. To arrive at a Gleason score, a pathologist examines ten to twenty tissue samples extracted during a prostate biopsy through the rectum. Low-grade prostate cancer – a six or lower on the Gleason score – is low risk and does not always require treatment. In these cases, it is often recommended that the patient undergoes active surveillance to monitor for higher grade disease or the cancer spreading. Patients with a Gleason score of seven or higher are typically at higher risk and more immediate evaluation and treatment is often recommended.

Prior to receiving a prostate biopsy, most patients undergo less invasive testing. Your doctor may order a prostate specific antigen (PSA) test which can help indicate if a biopsy is needed. Unfortunately, a high PSA test can be caused by a number of less serious conditions such as a benign enlargement of the prostate or prostate infection. This can sometimes lead to unnecessary biopsies or procedures.

The 4Kscore is a simple blood test that can help your doctor determine your risk for high grade, aggressive prostate cancer. By using the 4Kscore after an abnormal PSA test, doctors can better identify those men who are at a higher risk, and would benefit from further evaluations such as prostate biopsy, and avoid unnecessary procedures in men with a low risk.

Is it Time to be Screened for Prostate Cancer?

When was the last time you were screened for prostate cancer? Is it time to have a screening? According to the American Cancer Society the following ages are appropriate to discuss screening with your doctor: [3]

Men at average risk, who are expected to live for 10 or more years can wait until the age of 50 to begin screenings.

Men at high risk of developing the disease, either from family history or heritage, should begin screening at age 45.

Men at very high risk of developing the disease, meaning more than one of their first degree relatives (father, brother, or son) was diagnosed with prostate cancer at a young age should begin screenings at the age of 40.


If any of the above describes you, it’s time to schedule an appointment with your doctor. What better time to begin annual screenings than during National Prostate Cancer Awareness Month?  Contact your physician today or find a laboratory in your area to undergo a PSA and, if indicated, a 4Kscore test.

Ready to do your part to spread the word about Prostate Cancer Awareness Month? Share some lifesaving statistics!

If a man’s father or brother is diagnosed with prostate cancer, his risk factor more than doubles. Early diagnosis saves lives! Click to tweet

Did you know 4Kscore can help predict a man’s risk of prostate cancer metastases over the next 10 years? Click to tweet

If you are interested in learning more about prostate health throughout the year, follow our blog and connect with us on Facebook, Twitter, Google+ and LinkedIn. Join in the conversation!


  • American Cancer Society. Key statistics for prostate cancer. Available at (Accessed August 17, 2016).
  • American Cancer Society. Prostate cancer risk factors. Available at (Accessed August 17, 2016).
  • American Cancer Society. American Cancer Society recommendations for prostate cancer early detection. Available at (Accessed August 17, 2016).

OPKO to Discuss Draft Coverage Determinations for 4Kscore® Test at 2016 Jefferies Healthcare Conference

OPKO Health, Inc. (NYSE: OPK) today announced that senior management will discuss recent draft local coverage determinations by certain Medicare Administrative Contractors for OPKO’s 4Kscore® test at the Jefferies Healthcare Conference in New York City on Thursday, June 9, 2016 at 11:30 AM (EDT). OPKO previously announced that Novitas Solutions issued a positive draft local coverage determination proposing to establish reimbursement coverage for patients with PSA levels > 3 ng/mL who have not yet had a biopsy, or patients with a PSA level of > 3 ng/mL who have had at least one prior negative biopsy and are considered to be at higher risk. The draft coverage determination was subsequently retired by Novitas due to a potential conflict with another Medicare Administrative Contractor. Palmetto GBA had issued a draft non-coverage determination on May 27th for the 4Kscore test.

The 4Kscore test, extensively studied in over 22,000 patients with results presented in 12 peer reviewed scientific publications, improves health outcomes by avoiding unnecessary biopsies while accurately identifying men at high risk for a serious prostate cancer. The 4Kscore test has been adopted into NCCN guidelines and impacts physician and patient decisions while reducing healthcare costs. OPKO had not submitted complete dossiers to either Novitas or Palmetto in advance of their draft determinations and is providing both organizations with a complete data package including the background, extensive clinical validation and physician experience in support of the 4Kscore. OPKO believes there is more than enough scientific and clinical data to justify a positive local coverage decision by Medicare Administrative Contractors and intends to work closely with these organizations to demonstrate the value of the 4Kscore test to improve individual patient care as well as the efficiency of healthcare systems.

The Jefferies presentation will be webcast on the OPKO Investor Relations page of the corporate website at To access the live webcast please log on to the OPKO site approximately fifteen minutes before the presentation to register and download any necessary audio software. The audio presentation will be available at this link for a limited time after the live presentation.

About the 4Kscore Test

4Kscore is the only blood test that accurately identifies an individual patient’s risk for aggressive prostate cancer, the lethal form of prostate cancer. The 4Kscore test uses a proprietary algorithm that incorporates the blood levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and Human Kallikrein-2 (hK2), plus the patient’s age and other clinical information to calculate the percentage risk (probability) of finding a Gleason Score 7 or higher grade of prostate cancer. The four kallikrein panel of biomarkers utilized in the 4Kscore test is based on over a decade of research conducted by scientists at Memorial Sloan-Kettering Cancer Center and leading European institutions and is included as a standard-of-care in the 2015 National Comprehensive Cancer Network’s Prostate Cancer Early Detection Guidelines. The 4Kscore Test provides individualized risk for the presence of aggressive prostate cancer and adds new information to the shared decision-making discussion between the physician and the patient.

About OPKO Health, Inc.

OPKO Health, Inc. is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation’s third-largest clinical laboratory with a core genetic testing business and a 420-person sales force to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros®1 in-office immunoassay platform. Our pharmaceutical business features Rayaldee™, a treatment for secondary hyperparathyroidism in stage 3-4 chronic kidney disease patients with vitamin D insufficiency and VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner Tesaro, IV formulation in Phase 3). Our biologics business includes hGH-CTP, a once-weekly human growth hormone injection (in Phase 3 and partnered with Pfizer), a long-acting Factor VIIa drug for hemophilia (in Phase 2a) and a long acting oxyntomodulin for diabetes and obesity (in Phase 1). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information is available at


This press release contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning, including statements regarding expected benefits of the 4Kscore, our ability to obtain positive coverage for the 4Kscore from Novitas, as well as other Medicare Administrative Contractors and payers, whether OPKO has enough scientific and clinical data to justify a positive local coverage decision by any Medicare Administrative Contractor, whether the 4Kscore helps avoid unnecessary biopsies while accurately identifying men at high risk for a serious prostate cancer, the ability to improve patient outcomes and reduce biopsies, whether OPKO will successfully commercialize the 4Kscore, and the market for and expected sales of 4Kscore, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.