4Kscore featured on UroToday: AUA 2017

AUA 2017 just wrapped up in Boston, MA. On Sunday May, 14, Dr. Karim Marzouk and colleagues from Memorial Sloan Kettering Cancer Center presented a poster titled “Combining 4Kscore and MRI for Prostate Biopsy Decision Making”. The session highlighted the findings from the recently published PROMIS MRI trial, utilizing the multiparameteric MRI (mpMRI) as a follow-up test to the 4Kscore. Please read the full article about the session and study below and see the original post on UroToday.

 

AUA 2017: Combining 4KScore and MRI for Prostate Biopsy Decision Making

 

Boston, MA (UroToday.com) At today’s 2017 AUA Annual meeting prostate cancer diagnosis and screening podium session, Dr. Marzouk and colleagues presented their work from Memorial Sloan Kettering Cancer Center assessing the utility of multiparameteric MRI (mpMRI) as a follow-up test to the 4Kscore. As the recently published PROMIS MRI trial demonstrated, 11% of men with a normal MRI will have high-grade disease [1]. Since we have many biomarkers, including imaging modalities, available to clinicians in the pre-biopsy setting, studies delineating appropriate patient specific sequences of tests are important.

 

In this study, the 4Kscore results from the US prospective validation study were combined with mpMRI data available from the PROMIS study. The author used likelihood ratios for MRI detecting high grade disease from PROMIS (positive and negative likelihood ratio of 1.58 and 0.17, respectively) and applied these ratios to probabilities of 4Kscores. Four unique populations were identified based on a threshold for biopsy of 7.5% risk of high grade disease: (i) men with very low 4Kscore for whom risk would not be <7.5% even with positive MRI, (ii) men with 4Kscores <7.5% whose risk would be ≥7.5% if MRI were positive, (iii) men with 4Kscores ≥7.5% whose risk would be <7.5% if MRI were negative, and (iv) men with high 4Kscores whose risk would remain ≥7.5% even if MRI were negative. In the 4Kscore validation study, 1012 men underwent prostate biopsy 23% were diagnosed with ≥Gleason 7 disease. The range of 4Kscores that could be influenced by the results of MRI included 26% of the population with risk <5% (group 1), 10% with risk 5-7.4% (group 2), 45% with risk 7.5-32% (group 3), and 21% with risk > 32% (group 4). Importantly, the net benefit of using 4Kscores alone was 17.7%, mp-MRI 17.6%, and combined strategies was 18.2%.

 

In summary, this is an elegant study combining imaging and biomarkers to further delineate who should undergo a biopsy. Using mpMRI in the setting of low-intermediate 4Kscores results in a biopsy strategy with higher net benefit compared to using either modality alone.

 

See Original article at UroToday

OPKO Health’s 4Kscore® Test Highlighted in Podium Presentation at 112th American Urological Association Annual Meeting

Prospective study conducted at Veteran Affairs hospitals confirms 4Kscore accurately predicts aggressive prostate cancer

MIAMI, May 18, 2017 (GLOBE NEWSWIRE) — OPKO Health, Inc. (NASDAQ:OPK), announces that data from a prospective study conducted at Veteran Affairs (VA) hospitals confirming the 4Kscore test’s ability to accurately predict aggressive prostate cancer were presented in a podium presentation on May 16, 2017 at the 112th American Urological Association (AUA) Annual Meeting in Boston.

The study entitled, “An Independent, Multi-Institutional, Prospective study in the Veterans Affairs Health System confirms the 4Kscore accurately predicts aggressive prostate cancer,” was presented by Sanoj Punnen, M.D., Assistant Professor of Urologic Oncology at the Miller School of Medicine, Department of Urology at the University of Miami in Miami, Florida. The study is the second U.S. prospective clinical study to establish the clinical validity of the 4Kscore test to predict the presence of aggressive prostate cancer prior to performing a prostate biopsy.

The VA study was conducted at eight VA hospitals across the United States. A total of 366 men were enrolled in the study, and 208 (56%) of the participants were African American. Of all cancers diagnosed among African American men, prostate cancer is the most common (31% of all cancers), and African American men have a twofold greater risk of prostate cancer mortality compared to non-Hispanic whites.1

Overall, the 4Kscore demonstrated a high degree of accuracy for predicting the presence of aggressive (Gleason score 7 and higher) prostate cancer with an area under the receiver operator curve (AUC) of 0.81, significantly better than PSA alone or a clinical model based on PSA. Importantly, there was an equally high ability of the 4Kscore to discern aggressive disease in the African American men compared with the non-African American men (AUC = 0.80 v. 0.84, p = 0.32). The calibration and decision curve analysis were also consistent with the performance shown in the first U.S. validation study.

“The VA study confirms the 4Kscore’s accuracy in predicting a man’s risk of having aggressive prostate cancer and showed that it is an equally effective and vital clinical test for African American men, who have the highest rates of prostate cancer mortality,” said Phillip Frost, M.D., Chairman and CEO of OPKO Health. “These positive results add to our growing body of clinical evidence that demonstrate 4Kscore’s utility to accurately identify the risk of aggressive prostate cancer. Moreover, these data validate the clinical value of the 4Kscore test in a VA setting and show it to be identical to the performance previously shown in community and academic sites across the U.S. and Europe.”

About Prostate Cancer

According to the Prostate Cancer Foundation,2 “every 3.3 minutes a man is diagnosed with prostate cancer, and millions of men and their families are fighting the disease globally. In the United States, prostate cancer affects 1 in 8 men, making it the most common non-skin cancer in America. This means that a non-smoking man is more likely to develop prostate cancer than he is to develop colon, bladder, melanoma, lymphoma, and kidney cancers combined. In 2017 alone, it is estimated that more than 161,000 men will be diagnosed with prostate cancer, and more than 27,000 will die from the disease. A man of African descent is 73% more likely to develop prostate cancer than a Caucasian man, and more than twice as likely to die from the disease.”

About the 4Kscore™ Test

The 4Kscore is the only blood test that accurately identifies risk for aggressive prostate cancer. The 4Kscore measures the blood plasma levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and human kallikrein-related peptidase 2 (hK2). These biomarkers are combined with a patient’s age, digital rectal exam (DRE) status (nodule / no nodule), and prior negative biopsy status (yes / no) using a proprietary algorithm that calculates the risk (probability) of finding a Gleason Score 7 or higher 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. The 4Kscore test provides individualized risk for the presence of aggressive prostate cancer and adds new information to the patient-physician shared decision making discussion. The 4Kscore test is included in the 2016 National Comprehensive Cancer Network and 2016 European Association of Urology Prostate Cancer Guidelines.

About OPKO Health, Inc. 

OPKO Health 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 400-person sales and marketing team 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, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (launched in November 2016), VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation pending FDA approval), OPK88003, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, OPK88004, a SARM (Selective Androgen Receptor Modulator) for treating BPH (Benign Prostatic Hypertrophy) , OPK88002, a NK-1 antagonist to treat pruritus ( itching) in dialysis patients, and OPK88001, a proprietary oligonucleotide to treat Dravet Syndrome. In addition, the Company is advancing its CTP technology, which includes a long acting 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 in phase 2a. OPKO also has production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information available at www.opko.com.

Cautionary Statement Regarding Forward-Looking Statements

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 the clinical utility for the 4Kscore test, its ability to accurately predict aggressive prostate cancer in men generally and in the African American population, the expected benefits of our 4Kscore test, whether clinical trial results are indicative of the 4Kscore test’s ability to predict aggressive prostate cancer, 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 Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission. 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.

__

https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/cancer-facts-and-figures-for-african-americans/cancer-facts-and-figures-for-african-americans-2016-2018.pdf

https://www.pcf.org/c/about-the-prostate-cancer-foundation/

OPKO Announces Multiple Presentations at the 112th American Urological Association Annual Meeting

Highlights 4Kscore’s ability to predict aggressive prostate cancer

Showcasing 4Kscore and Claros 1 Point-of-Care System at Exhibit Booth #904

MIAMI, May 15, 2017 (GLOBE NEWSWIRE) — OPKO Health, Inc. (Nasdaq:OPK) announces that multiple podium and poster presentations highlighting the Company’s 4Kscore test will be presented at the 112th American Urological Association (AUA) Annual Meeting taking place from May 12-16, 2017 in Boston.

The following podium and poster presentations highlighting the 4Kscore test will take place in Room 162 of the Boston Convention and Exhibition Center:

Title: The 4Kscore Test Accurately Predicts Aggressive Prostate Cancer in Men of all Ages and Race”
Poster: Poster presentation PD07-01
Date/Time: May 12, 2017 at 9:30 am ET
Title: Combining 4KScore and MRI for prostate biopsy decision making”
Poster: Poster presentation PD40-08
Date/Time: May 14, 2017 at 9:30 am ET
Title: A four-kallikrein panel in predicting high-grade prostate cancer on biopsy: an independent replication from the Finnish section of the European Randomized Study of Screening for Prostate Cancer”
Poster: Poster presentation PD40-06
Date/Time: May 14, 2017 at 10:20 am ET
Title: Does 4K and/or Michigan Prostate Score Change Cancer Detection Rates in Multi-Parametric MRI discovered PIRADS 3 or Lower Lesions?”
Poster: Poster presentation PD65-09
Date/Time: May 16, 2017 at 8:20 am ET
Title: An Independent, Multi-Institutional, Prospective study in the Veterans Affairs Health System confirms the 4Kscore accurately predicts aggressive prostate cancer”
Podium: Podium presentation PD71-04
Date/Time: May 16, 2017 at 10:00 am ET

To learn more about the Company’s 4Kscore test and Claros 1 Point-of-Care system, visit the OPKO Health Booth #904 in the Exhibit Hall.

About the 4Kscore™ Test
The 4Kscore is the only blood test that accurately identifies risk for aggressive prostate cancer. The 4Kscore measures the blood plasma levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and human kallikrein-related peptidase 2 (hK2). These biomarkers are combined with a patient’s age, digital rectal exam (DRE) status (nodule / no nodule), and prior negative biopsy status (yes / no) using a proprietary algorithm that calculates the risk (probability) of finding a Gleason Score 7 or higher 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. The 4Kscore test provides individualized risk for the presence of aggressive prostate cancer and adds new information to the patient-physician shared decision making discussion. The 4Kscore test is included in the 2016 National Comprehensive Cancer Network and 2016 European Association of Urology Prostate Cancer Guidelines.

About OPKO Health, Inc.
OPKO Health 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 400-person sales and marketing team 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, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (launched in November 2016), VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation pending FDA approval), OPK88003, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, OPK88004, an androgen receptor modulator for androgen deficiency indications, OPK88002, a NK-1 inhibitor to treat pruritus (severe itching) in dialysis patients, and OPK88001, a proprietary oligonucleotide to treat Dravet Syndrome. In addition, the Company is advancing its CTP technology, which includes a long-acting 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 in phase 2a.  OPKO also has production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information available at www.opko.com.

Cautionary Statement Regarding Forward-Looking Statements
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 clinical utility and financial performance and expectations regarding our 4Kscore test  and the expected benefits of our 4Kscore test, whether clinical trial results are indicative of the 4Kscore test’s ability to predict aggressive prostate cancer,  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 Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission, as well as 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.

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 4Kscore.com.

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

A Better Prostate Cancer Test? New Advanced Tools Help Identify Aggressive Prostate Cancer

“The goal of diagnosing and treating prostate cancer is diagnosing it early on when it’s confined to the prostate”

NEW YORK, NY–(Marketwired – Sep 7, 2016) – During their lifetime approximately one in seven men will be diagnosed with prostate cancer, the second most common cancer among men in the U.S. The odds increase for African Americans and double for those with a family history of the disease.

In 2016, there are expected to be 180,890 new cases of prostate cancer, which increases the demand for prostate-specific antigen (PSA) blood tests. These screenings play a key role in diagnosing and treating prostate cancer early on, when it’s confined to the prostate and still curable.

According to Dr. Harry Fisch, Board Certified Urologist at New York Presbyterian Hospital/Weill Medical College of Cornell University, the screening process is simple. Dr. Fisch explains that a doctor performs a digital rectal exam, followed by a blood test to detect and asses the prostate-specific antigens that are present in the blood. Through this simple process, men will know if they are at a risk for prostate cancer. Men need to be aware both of the risk for prostate cancer and how simple an initial screening can be. Most men don’t know what their PSA level is, or if they do, what it means. This is the critical part of the diagnosis. If their level is deemed “high,” the doctor may recommend a biopsy, but of the one million prostate biopsies performed each year, a full 75 percent of them reveal no cancer.

The good news is that advanced tests are constantly being developed, including a new tool from OPKO Health, the 4Kscore Test. This simple blood test fills the gap between a PSA and a biopsy, because it is able to offer a closer look at a higher PSA reading and — before deciding if an individual needs a biopsy — far more accurately assess his risk of having aggressive prostate cancer. The 4Kscore Test takes the PSA level into account, in addition to three other prostate-specific proteins. This helps identify men who may have gone undiagnosed and need a biopsy, while reducing the need for a biopsy in lower risk men. The 4Kscore is performed at BioReference Laboratories and GenPath Diagnostics, and is used by physicians across the country.
For more information, visit 4Kscore.com.

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.

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.

Study Demonstrates OPKO’s 4Kscore Test Reduces Unnecessary Prostate Biopsies While Improving Risk Prediction for Aggressive Prostate Cancer

OPKO Health, Inc. (NYSE: OPK) announced today the results of a study for the 4Kscore® Test’s clinical utility in reducing the number of prostate biopsies performed, while increasing the probability of detecting aggressive prostate cancer in men with abnormal prostate-specific antigen (PSA) levels and or digital rectal examination (DRE) results. The peer-reviewed study, “The 4Kscore® Test Reduces Prostate Biopsy Rates in Community and Academic Urology Practices”, written by Badrinath Konety, MD, et al. and published in the January 2016 edition of Reviews in Urology, a MedReviews, LLC. Publication, which included 611 patients seen by 35 academic and community urologists across the United States, indicated that consideration of results from the 4Kscore tests led to 64.6% fewer prostate biopsies being performed among participating patients.

“The 4Kscore test is a useful tool in identifying men with a significant risk of having an aggressive form of prostate cancer, who are most likely to benefit from a prostate biopsy and selective treatment or intensive intervention, while avoiding biopsies in men who are at low risk for developing aggressive disease,” commented lead researcher Badrinath Konety, M.D., Dougherty Family Chair in Uro-Oncology and director of the Institute for Prostate and Urologic Cancers at the University of Minnesota. “Our findings suggest that PSA screening, when coupled with the 4Kscore test, can be made more specific, reduce biopsy complications and overtreatment, and be a more cost-effective solution for managing a patient’s prostate health.”

Dr. Konety and colleagues evaluated the influence of the 4Kscore test on urologist-patient decisions about whether to perform a biopsy in men who had an abnormal PSA and or DRE result. Test results for patients were stratified into low risk (<7.5%), intermediate risk (7.5%-19.9%) and high risk (≥20%) for developing aggressive prostate cancer. Nearly half (49.3%) of the men were categorized as low risk; 25.7% and 25.0% fell into the intermediate-risk and high-risk categories, respectively. Notably, the 4Kscore test results influenced biopsy decisions in 88.7% of the men. In the three risk groups, a biopsy was avoided in 94.0%, 52.9%, and 19.0% of men in the low, intermediate, and high-risk categories, respectively.

A higher 4Kscore test result was significantly associated with a greater likelihood of having a prostate biopsy (P< 0.001). Among the 171 men who had a biopsy, 45 of the 104 cases (43.3%) with a high-risk 4Kscore test result (≥20% risk) were found to have aggressive prostate cancer upon prostate biopsy.

About the 4Kscore Test

The 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 NCCN 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 Urologist 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 (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, 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.