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.

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  • This Year’s Top New Year’s Resolution? Fitness!! Available at https://www.nielsen.com/us/en/insights/news/2015/2015s-top-new-years-resolution-fitness.html. (Accessed December 11, 2016).
  • American Cancer Society. Does body weight affect cancer risk? Available at https://www.cancer.org/cancer/cancercauses/dietandphysicalactivity/bodyweightandcancerrisk/body-weight-and-cancer-risk-effects. (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 https://www.cancer.gov/types/prostate/hp/prostate-genetics-pdq. (Accessed December 8, 2016).
  • National Cancer Institute. Genetic Testing for Hereditary Cancer Syndromes. Available https://www.cancer.gov/about-cancer/causes-prevention/genetics/genetic-testing-fact-sheet. (Accessed December 8, 2016).

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 https://www.nejm.org/doi/full/10.1056/NEJMc1602012. (Accessed November 15, 2016).
  • National Institute of Diabetes and Digestive and Kidney Disease. Health Risks of Being Overweight. Available at https://www.niddk.nih.gov/health-information/health-topics/weight-control/health_risks_being_overweight/Pages/health-risks-being-overweight.aspx. (Accessed November 16, 2016).
  • National Cancer Institute. Physical Activity and Cancer. Available at https://www.cancer.gov/about-cancer/causes-prevention/risk/obesity/physical-activity-fact-sheet#q8. (Accessed December 1, 2016)
  • JAMA Oncology. Midlife Cardiorespiratory Fitness, Incident Cancer, and Survival After Cancer in Men. Available at https://jamanetwork.com/journals/jamaoncology/fullarticle/2203829 (Accessed December 1, 2016)
  • National Cancer Institute. Physical Activity and Cancer. Available at https://www.cancer.gov/about-cancer/causes-prevention/risk/obesity/physical-activity-fact-sheet#r9. (Accessed December 1, 2016)

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 https://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-key-statistics (Accessed August 17, 2016).
  • American Cancer Society. Prostate cancer risk factors. Available at https://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-risk-factors (Accessed August 17, 2016).
  • American Cancer Society. American Cancer Society recommendations for prostate cancer early detection. Available at https://www.cancer.org/cancer/prostatecancer/moreinformation/prostatecancerearlydetection/prostate-cancer-early-detection-acs-recommendations (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 www.opko.com. 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 www.opko.com.

SAFE HARBOR STATEMENT

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.

OPKO Health Receives Proposed/Draft Medicare Local Coverage Determination for 4Kscore® Test

OPKO Health, Inc. (NYSE:OPK) (“OPKO” or the “Company”) announces that Novitas Solutions has issued a draft local coverage determination for the 4Kscore® Test, the only blood test that accurately identifies an individual patient’s risk for high-grade, aggressive prostate cancer. Novitas Solutions is a Medicare Administrative Contractor (MAC) for Medicare jurisdictions L and H, with responsibility for nearly 10 million Medicare beneficiaries in New Jersey, Pennsylvania, Maryland, the District of Columbia and Texas, among other geographies.

The draft local coverage determination is posted to the Medicare Coverage Database on the Centers for Medicare & Medicaid Services (CMS) website, and proposes 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.

“This first MAC determination is a major milestone for the 4Kscore Test as it expands access to a potentially life-saving tool,” said Phillip Frost, M.D., OPKO’s Chairman and Chief Executive Officer. “We believe this decision by Novitas will help accelerate further coverage decisions by other payers, and will encourage adoption of the 4Kscore Test by physicians and patients. More importantly, it will allow broader access to this important test, which can assist patients and physicians in further defining a patient’s risk of having a high-grade prostate cancer that requires immediate or aggressive treatment.”

The draft local coverage determination follows the 4Kscore’s inclusion as a standard-of-care in the 2015 National Comprehensive Cancer Network Guidelines and in the 2016 European Association of Urology Prostate Cancer Guidelines for Prostate Cancer.

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 (SHPT) in stage 3-4 chronic kidney disease (CKD) patients with vitamin D insufficiency (pending FDA approval) 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), and a long-acting Factor VIIa drug for hemophilia (entering Phase 2a). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information is available at www.opko.com.

SAFE HARBOR STATEMENT

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, the ability to obtain broader access to the tests for patients, our ability to accelerate coverage decisions, the power of the 4Kscore to provide valuable information to accurately identify aggressive prostate cancer and guide clinical decision making, whether it will accurately predict high-grade cancers, 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.

 

OPKO 4Kscore® Recommended in 2016 European Association of Urology Prostate Cancer Guidelines

OPKO Health, Inc. (NYSE:OPK) today announced the decision of the European Association of Urology (EAU) Prostate Cancer Guidelines Panel to include the 4Kscore® Test in the 2016 EAU Guidelines for Prostate Cancer. The panel concluded that the 4Kscore, as a blood test with greater specificity over the PSA test, is indicated for use prior to a first prostate biopsy or after a negative biopsy to assist patients and physicians in further defining the probability of high-grade cancer.

“The EAU Prostate Cancer Guidelines Panel is an international, multi-disciplinary group of specialists in prostate cancer diagnosis and treatment,” said Dr. Alberto Briganti, Department of Urology, San Raffaele Scientific Institute, Milan, Italy. “The decision to include the 4Kscore in the guidelines indicates that the Panel views the 4Kscore Test as having achieved an appropriate level of clinical evidence to recommend its use for both assessment of asymptomatic men prior to a first prostate biopsy and as an additional investigational test to be done after a negative prostate biopsy.”

The 4Kscore test has been studied on over 22,000 patients with results published in 12 peer-reviewed scientific publications. The 4Kscore test is the only blood test that accurately identifies an individual patient’s risk for high-grade, aggressive cancer.

About the 4Kscore Test

The 4Kscore, a laboratory developed test, 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 both the 2016 NCCN Early Detection Guidelines and the 2016 EAU Guidelines for prostate cancer. 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 Urologist and the patient.

About OPKO Health

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 (SHPT) in stage 3-4 chronic kidney disease (CKD) patients with vitamin D insufficiency (March 29, 2016 PDUFA date) 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), and a long-acting Factor VIIa drug for hemophilia (entering Phase 2a). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information is available at www.opko.com.

SAFE HARBOR STATEMENT

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, the power of the 4Kscore to provide valuable information to accurately identify aggressive prostate cancer and guide clinical decision making, whether it will accurately predict high-grade cancers, reduce overtreatment and provide a cost effective solution for managing prostate health, whether OPKO will successfully commercialize the 4Kscore in the U.S. and Europe, 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.

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.