USPSTF Releases Draft Recommendations for PSA Testing

With the release of a new draft document, the U.S. Preventative Services Task Force (USPSTF) has proposed a change in its stance on the advisability of PSA prostate cancer screening for men ages 55 to 69. The new recommendations are based on evidence that supports some benefit to such screenings for the early detection of aggressive prostate cancer. However, the USPSTF also acknowledges offsetting harms from the invasive testing and treatment that may follow a positive PSA screen.

USPSTF Draft of Updated Recommendation on Prostate Cancer Screening

The USPSTF draft document details proposed revisions to the 2012 recommendations concerning prostate-specific antigen (PSA) screenings for prostate cancer. These recommendations revise the USPSTF grades assigned to the use of routine PSA-based prostate cancer screening in two age categories:

  1. Men ages 55 to 69 years
  2. Men ages 70 years & older

The previous grade for both age groups was “D,” recommending against such routine screening. The new draft recommendation retains the “D” designation for men 70 and older but revises the grade to “C” for men in the younger category.

Informed Decision-Making by Individual Patients

The USPSTF makes recommendations on the effectiveness of preventative care services such as PSA prostate cancer screening based on evidence of both benefit and harm. For men 55 to 69 years, the proposed grade of “C” indicates a balance between potential benefit from early cancer detection and the possible harmful outcomes that may result from screening. These include:

  • False-positive results leading to additional testing
  • Overdiagnosis & overtreatment
  • Treatment complications

The USPSTF urges clinicians to discuss the advantages and potential risks of PSA screening with their patients, so individuals in the 55 to 69 age category have the information they need to make an informed decision about proceeding with PSA testing.

Limited Potential Benefits from Standard PSA Screening

Although prostate cancer is one of the most common cancers in men, not all prostate cancers are aggressive or likely to metastasize. Some men who have been screened and identified as having cancer showed no symptoms and may not have been aware of the condition if they had not been screened. Autopsies performed on men who died of other causes reveal an incidence of prostate cancer by age group of:

  • 25% for men ages 55 to 69
  • 33% for men ages 70 & over

The USPSTF has found adequate data from random clinical trials that screening may prevent some cases of metastasized cancer deaths: up to three cases per 1000 men (55 to 69 years of age) screened over a 13-year period. The draft recommendation notes that PSA screening is ineffective at distinguishing between aggressive cancers that are likely to metastasize and cancer that either does not progress or progresses so slowly that the patient never experiences symptoms. The proposed recommendation also notes that further research is needed for developing and studying different diagnostic tests and protocols.

False-Positive Cancer Diagnosis & Overdiagnosis

According to the draft recommendation of the USPSTF, the potential benefit of routine PSA screening for men ages 55 to 69 is offset by these severe shortcomings in test interpretation:

  • Conditions like an enlarged prostate (benign prostatic hyperplasia) and inflammation of the prostate (prostatitis) also deliver elevated PSA readings. A false-positive PSA reading puts men at risk for side effects and complications from further diagnostic testing procedures.
  • A positive PSA screening result may lead to overdiagnosis and overtreatment of cancer in men whose prostate cancer would never have become symptomatic while they lived. In such cases, these men would receive no benefit from treatment. The USPSTF draft cites large randomized trials that indicate that 20% to 50% of men diagnosed with prostate cancer through screening may represent overdiagnosis of the condition.1

Harmful Outcomes from Additional Diagnostic Tests & Overtreatment

According to the USPSTF draft document, there is adequate evidence that further diagnostic testing and cancer treatment may result in a moderate chance of harm. Additional testing and biopsy due to false-positive PSA results may include pain, infection, hematospermia (blood in semen or ejaculate), and complications severe enough to require hospitalization. Men undergoing prostate cancer treatment are also subject to unpleasant health and lifestyle side effects including long-term sexual impotence, urinary incontinence, and bowel urgency or bowel incontinence.

USPSTF Grade-Change Considerations

Data from random trials, cohort studies and decision analysis models reviewed by USPSTF support the conclusion that the benefit of PSA-based screening for men ages 55 to 69 depends on the value judgments of individual men. Although PSA screening has the potential for early detection and treatment that may save lives, that potential is balanced by the possibility of overdiagnosis, false-positive indications, and complications of treatment that could affect quality of life.

USPSTF’s recommended grade change to “C” for men in the younger screening age group is an acknowledgment that men should have an opportunity to make informed decisions about PSA screening results and the need for further tests or treatments following a positive result. The draft proposal also provides study information for men with a higher risk of developing prostate cancer, including African American men and men with a family history of the disease. The USPSTF supports the role of the clinician in providing updated, evidence-based information and providing all groups with the full picture for making decisions about PSA-based prostate cancer screening.

 

1  Fenton JJ, Weyrich MS, Durbin S, Liu Y, Bang H, Melnikow J. Prostate-Specific Antigen-Based Screening for Prostate Cancer: A Systematic Evidence Review for the U.S. Preventive Services Task Force. Evidence Synthesis No. 154. AHRQ Publication No. 17-05229-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2017.

Why is it Important to Know if I have Aggressive Prostate Cancer?

Prostate Cancer is the second leading cause of cancer death in men in the United States. In fact, it is estimated that 26,120 men will die of prostate cancer in 2017 alone. [1] While these figures are alarming, not all forms of prostate cancer are equally dangerous.  Those types of prostate cancer that are indolent and unlikely to spread have good survival rates, with 5-year survival of [2]:

  • Localized prostate cancer 100%
  • Regional prostate cancer 100%
  • Distant metastatic prostate cancer 29.8%
  • Unstaged prostate cancer 81.2%

Aggressive vs Low Grade Prostate Cancer

Low-grade prostate cancers are generally considered to be non-life threatening, and in many cases the patient may not even require treatment. Physicians often recommend patients with low-grade prostate cancer (Gleason Score = 6) simply be monitored with active surveillance. Prostate cancers with a Gleason Score ranging between 7 and 10, however, are considered aggressive and may be life threatening. In many cases, those men diagnosed with aggressive prostate cancer can benefit from and should receive early treatment.

Detecting Aggressive Prostate Cancer

The PSA test is a widely-used blood test designed to detect Prostate-Specific Antigens (PSA) in the bloodstream. Though an elevated PSA level can be indicative of a higher risk level of developing prostate cancer, it does not effectively differentiate between prostate cancer and other less serious health conditions. Oftentimes, an elevated PSA score does not indicate the presence of prostate cancer.

The 4Kscore is a blood test performed after an abnormal PSA that provides men with an accurate risk of having aggressive prostate cancer, and categorizes their risk of developing distant metastasis for over 10 years. [3, 4] It combines four prostate protein levels and clinical findings to provide a risk score for aggressive prostate cancer, which can then be used by men and their doctors in the biopsy decision making process.

By providing the risk of aggressive prostate cancer after an abnormal PSA, the 4Kscore is revolutionizing the way physicians and patients approach prostate cancer diagnosis. As a result, men with a low risk can avoid an unnecessary prostate biopsy, while higher risk men can get the appropriate evaluation and treatment. [5]

How do you know if you have aggressive prostate cancer?

Ready to Learn More About the 4Kscore?

At GenPath and BioReference, OPKO Health Companies, we often hear from both physicians and patients interested in learning more about the 4Kscore Test. If you are a physician interested in offering the 4Kscore Test to your patients, contact us today. Begin offering the 4Kscore Test in your practice and join our physician locater tool. If you are a patient who would like to encourage your physician to begin offering the 4Kscore Test, reach out to us. Together we can save lives!

Are you interested in learning more about prostate health? Subscribe to our blog and connect with us on Facebook, Twitter, Google+ and LinkedIn. Join in the conversation!

 

[1] Cancer.net. Prostate Cancer: Statistics. Available at https://www.cancer.net/cancer-types/prostate-cancer/statistics. (Accessed on April 5, 2017).

[2] NIH: Cancer Stat Facts: Prostate Cancer. Available at https://seer.cancer.gov/statfacts/html/prost.html (Access August 1, 2017)

[3] Parekh DJ, Punnen Sm, Sjoberg DDm et al. A Multi-institutional Prospective Trial in the USA Confirms that the 4Kscore Accurately Identifies Men with High-grade Prostate Cancer. Eur Urol. 2015; 68:464-70.

[4] Stattin P, Vickers AJ, Sjoberg DD, et al. Improving the Specificity of Screening for Lethal Prostate Cancer Using Prostate-specific Antigen and a Panel of Kallikrein Markers: A Nested Case-Control Study. Euro Urol. 2015; 68:207-213.

[5] Konety B, Zappala SM, Parekh DJ, et al. The 4Kscore® Test Reduces Prostate Biopsy Rates in Community and Academic Urology Practices. Rev Urol. 2015; 17(4):231-40.

 

Who is the Ideal Candidate for the 4Kscore Test?

The 4Kscore is a simple blood test which analyzes four prostate-specific biomarkers in the blood along with clinical information. The results of the 4Kscore Test provide each patient with a personalized, accurate measurement of their risk for having aggressive prostate cancer; information which can be used to help in the biopsy decision making process.

Are you a candidate for the 4Kscore Test?

For many years, doctors and patients relied on the PSA test when considering a prostate biopsy. However, PSA results alone do not clearly distinguish between the risk of aggressive prostate cancer and other less serious health conditions. All too often, abnormal PSA results have lead to unnecessary prostate biopsies and treatments, the results of which can have serious side effects.

If you, or a loved one, have recently received news of an abnormal PSA score, chances are you’re looking for answers. Because an abnormal PSA score is not necessarily specific for aggressive prostate cancer, it is important to learn more about your personal risk. Men with an abnormal screening test result, such as PSA, are candidates for the 4Kscore Test. Together a patient and his physician can use the 4Kscore to help determine whether or not he should undergo a prostate biopsy.

Evaluating the risk for aggressive prostate cancer

The 4Kscore helps men identify their risk for high grade prostate cancer. The stress associated with undergoing a prostate biopsy, in addition to the potential complications, make it critical for medical professionals to be able to differentiate between low risk and high risk patients. The 4Kscore Test is helping to do just that. Patients at low risk can avoid unnecessary medical procedures and those at high risk can be identified and recieve appropriate follow-up.

If you believe that you, or a loved one, are a candidate for the 4Kscore test, we encourage you to speak to your doctor. If your doctor orders the 4Kscore test for you, you can find a 4Kscore test blood draw site in your area. If you are a physician interested in offering the 4Kscore Test, we encourage you to contact us today. Learn more about how this simple blood test is helping to clarify the biopsy decision making process.

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

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/

Announcing a Drop in the Price of the 4Kscore™ Test

We often hear from patients and physicians alike interested in learning more about the 4Kscore test as well as the associated cost. We have always worked to offer the 4Kscore tests at a reasonable price. With our Patient Health Advocacy Program, we are committed to increasing access to the 4Kscore for patients who do not have health insurance. Through these efforts, we have been successful in making comprehensive testing available to an expanding network of patients.

The New Price of the 4Kscore Test

We are very excited to announce that the 4Kscore test is now more affordable. The price has been reduced from $1900 to $595, making testing more accessible to men at an increased risk of having aggressive prostate cancer. If you would like to discuss your specific situation, and our self-pay and payment plan options, please call our specialized billing hotline at 855-4KBILLING (855-452-4554) between the hours of 9am and 9pm EST, Monday-Friday.

The Cost of Unnecessary Biopsies

As we recently discussed in a post on the topic, the cost associated with unnecessary biopsies preformed in the United States annually is staggering. Not only is the 4Kscore aiding in the biopsy decision making process, it can help to reduce the number of unnecessary biopsies performed on an annual basis.

In helping patients, along with their doctors, make informed decisions about prostate biopsies, the 4Kscore is dramatically reducing the pain and cost associated with unnecessary procedures.1 In reducing the cost of the 4Kscore, we aim to make an even greater impact in the fight against prostate cancer.

Learn More About the 4Kscore Test

Whether you are a patient or a physician, we encourage you to contact us today. Learn more about the benefits of the 4Kscore. Find a laboratory in your area or begin offering the 4Kscore in your practice. Together we can make a difference!

 

  1. Voigt, J. D., MPH, MBA, Dong, Y., PhD, Linder, V., PhD, & Zappala, S., MD. (2017). Use of the 4Kscore Test to Predict the Risk of Aggressive Prostate Cancer Prior to Prostate Biopsy: Overall Cost Savings and Improved Quality of Care to the US Healthcare System. Reviews in Urology, 19(1), 1-10.

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.

We Hope to See You at AUA2017!

The American Urological Association’s 2017 Annual Meeting is just around the corner. This annual event provides the ideal platform for thought leaders in the field to explore the latest advances in urologic medicine. Attendees from around the globe will gather in Boston, Massachusetts, May 12 – 16, for the 112th AUA Annual Meeting. Last year’s meeting attracted more than 16,000 attendees, from 111 countries, a testament to its significance in the international urologic medical community.

Connect with GenPath at Booth 904

At GenPath, we are gearing up for AUA2017 and we hope to see you there! Be sure to visit our booth to learn more about the larger impact of the 4Kscore. Connect with our team and get answers to your questions.

Join us throughout the week for talks and symposiums including:

Advancements in Prostate Cancer Diagnostics: Genetic Testing & 4Kscore

Attendees will learn about an exciting development from our genetics division, GeneDx; a new panel that tests for hereditary prostate cancer genes to help patients understand their genetic risk for the disease and clinicians make management decisions. We will also explore how the 4Kscore and genetic testing can fit into the urology practice.

  • Speakers:
    • Benjamin D. Solomon, MD, FACMG – Managing Director, GeneDx
    • Sanoj Punnen, MD, MAS – Assistant Professor of Urologic Oncology, University of Miami, Miller School of Medicine and Sylvester Comprehensive Cancer Center
    • Mitchell Steiner, MD, FACS – Moderator
  • Date: Sunday, May 14, 2017
  • Time: 10:00AM – 11:00AM
  • Location: ICU Theatre – Booth 1354

Pre-register today!

4Kscore: An Actionable Biomarker in an Era of Accountable Care

Attendees will learn more about 4Kscore and how their patients will benefit from the test.

  • Speaker: Dr. Steve Zappala
  • Dates/Times: Saturday 5/13 and Monday 5/15 at 10:30AM
  • Location: Booth 904

GeneDx: Supporting Urologists in the Evaluation of Hereditary Prostate Cancer through Genetic Testing

Attendees will discover how genetic testing can easily fit into a Urologist’s practice and inform medical management.

  • Speaker: Lance Grau (Genetic Counselor for GeneDx)
  • Dates/Times: Saturday 5/13, Sunday 5/14, and Monday 5/15 at 12:30PM
  • Location: Booth 904

The Role of 4Kscore and Multiparametric MRI for Diagnosing Aggressive Prostate Cancer

Attendees will learn how Urologists are combining the 4Kscore and MRI in the evaluation of men suspected of having aggressive prostate cancer.

  • Speaker: Dr. Jay Newmark
  • Dates/Times: Saturday 5/13, Sunday 5/14, and Monday 5/15 at 2:30PM
  • Location: Booth 904

Discover More About the 4Kscore at AUA2017

Not only will we be sponsoring a booth and hosting a number of talks, the 4Kscore will also be featured in AUA Curriculum by independent physicians. Do not miss your chance to learn more about the vital role the 4Kscore is playing in modern urologic medicine.

The 4Kscore Test Accurately Predicts Aggressive Prostate Cancer in Men of all Ages and Race

  • Date: Friday, May 12, 2017
  • Time: 9:30AM

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

  • Date: Sunday, May 14, 2017
  • Time: 10:20AM

Combining 4Kscore and MRI for Prostate Biopsy Decision Making

  • Date: Sunday, May 14, 2017
  • Time: 10:40AM

Does 4K and/or Michigan Prostate Score Change Cancer Detection Rates in Multi-Parametric MRI discovered PIRADS 3 or Lower Lesions

  • Date: Tuesday, May 16, 2017
  • Time: 8:20AM

An Independent, Multi-Institutional, Prospective study in the Veterans Affairs Health System confirms the 4Kscore accurately predicts aggressive prostate cancer

  • Date: Tuesday, May 16, 2017
  • Time: 10:00AM

Ready to Learn More About the 4Kscore?

Will you be attending AUA2017? If so, we encourage you to visit our booth and to take in the symposiums and talks outlined above. If you will not be attending this year’s meeting, be sure to connect with us on Facebook, Twitter, Google+ and LinkedIn. Stay in-the-know about the exciting advancements in urological medicine that will be announced at this year’s meeting. Join in the conversation!

 

GenPath is a division of BioReference Laboratories, Inc.

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 4kscoreinquiry@bioreference.com. 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 https://www.cdc.gov/nchs/pressroom/01news/newstudy.htm. (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