Physicians

A Diagnostic Blood Test for Assessing Risk of Aggressive Prostate Cancer

Aggressive Prostate Cancer

A Challenging Diagnosis

Prostate cancer continues to be the most common non-cutaneous malignancy in American men. In 2019, it’s estimated that 175,000 men will be diagnosed with prostate cancer1, and although the vast majority of these tumors will be the indolent form of prostate cancer, over 31,600 men in the US are expected to die from the disease this year1.

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For information on diagnostic testing options for the male reproductive system offered through GenPath Urology, click here.

 

Novitas Issues Final Local Coverage Determination for the 4Kscore® Test   

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The 4Kscore® Test

The 4Kscore® Test combines four prostate-specific biomarkers (Total PSA, Free PSA, Intact PSA, and human kallikrein 2 [hK2]) with important clinical factors (age, prior biopsy status, and optional DRE) to provide a man's risk of high-grade prostate cancer (Gleason 7 or higher) if a prostate biopsy were performed and categorizes long-term risk of prostate cancer metastasis and mortality for up to 20 years.

4Kscore® Test is indicated after an abnormal PSA and/or DRE, prior to the first biopsy or after a negative biopsy, to assist with making a prostate biopsy decision. The 4Kscore® Test is included in current US, Canadian, and European prostate cancer early detection guidelines, and over a dozen studies in more than 20,000 men attest to its clinical effectiveness.

The 4Kscore® Result

The 4Kscore® Test result is a patient's percent risk of finding high-grade prostate cancer (Gleason 7 or higher) if a prostate biopsy were to be performed. 

Two US based prospective validation studies resulted in combined sensitivity of 94% and Negative Predictive Value (NPV) of 95% for the detection of aggressive prostate cancer when a 7.5% cutoff value was used.2,3

In addition, two large observational studies have shown that men with a low-risk 4Kscore® <7.5% have a low long-term risk of developing metastasis or of prostate cancer mortality.4,5

NOTE: Biotin supplementation (>5 mg/day) may cause interference with assays that are components of the 4Kscore Test and may impact the 4Kscore Test result.

Better Information for
Confident Decisions 

The 4Kscore® Test result assists with prostate biopsy decisions by providing an accurate assessment of risk for aggressive prostate cancer in men with an abnormal PSA and/or DRE. 4Kscore® Test results are evaluated along with other important clinical information (health status, medical history, family history of prostate cancer, PSA history, etc.) as part of the shared decision-making process.

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Making a Shared Decision

DISCUSS PROSTATE CANCER
Screening for prostate cancer is an individual decision that you can help your patients make. 1 in 9 men will be diagnosed with prostate cancer in their lifetime.1

MAKING A SHARED DECISION
The appropriate management for each patient depends on medical history, clinical findings, and preferences after discussing several options with you. Shared decision making helps your patients and their loved ones make informed decisions.

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This is a guide for screening and evaluation of aggressive prostate cancer and is not all inclusive of the risks, benefits, or complications for procedures and tests described. Please review this decision aid with your patients to determine the next steps in their care.

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“The biggest challenge is to understand whether a prostate cancer is favorable or not, and the 4Kscore® helps to identify those cases to make clinical decisions specific to the patient.”

- David M. Albala
   Medical Director, Associated Medical Professionals

“I think the 4Kscore® Test is a great tool for helping us learn how to test smarter, how to screen patients with PSA smarter and more accurately.”

- Badrinath Konety, MD
   Chair, Department of Urology, University of Minnesota

 

GenPath Urology

GenPath Urology provides comprehensive testing services to help monitor and evaluate urologic health including:  

  • Prostate Health: Our test portfolio can assist you with screening, diagnosis, and management of prostate conditions.
  • Bladder Cancer: GenPath offers testing, including UroVysion®, that can aid in the detection and monitoring of bladder cancer.
  • Stone Analysis and Risk: GenPath performs analysis of stones that have passed and monitors important indicators to understand the risk of stone formation.
  • Sexually Transmitted Infections: We offer a number of sexual health tests to help determine a patient’s sexual status and provide timely treatment, helping to avoid further complications.
  • Hereditary Cancer Testing: In collaboration with GeneDx, GenPath offers testing if your patient’s individual and/or family history is suggestive of a hereditary predisposition to prostate cancer or renal cancer.

Physician FAQ

The 4Kscore® Test is a simple blood test that provides an assessment of a patient’s risk for aggressive prostate cancer. It combines four prostate-specific biomarkers along with patient clinical information in a complex algorithm that provides a risk score for aggressive prostate cancer if a biopsy were to be performed. The 4Kscore® Test allows patients and physicians to make better-informed decisions in determining if a prostate biopsy is needed.

The 4Kscore® Test result assesses the risk of finding high-grade prostate cancer if a biopsy were performed and has been shown to categorize long-term risk of prostate cancer metastasis and mortality. By specifically assessing the risk for aggressive prostate cancer after an abnormal screening result, the 4Kscore® Test helps low-risk men avoid a prostate biopsy they may not need, while identifying men with an elevated risk who may benefit from early intervention.

The 4Kscore® Test measures the serum levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA, and human kallikrein 2 (hK2). Levels of these biomarkers are combined with a patient’s age, prior biopsy status, and DRE (optional), and processed using a clinically validated algorithm to calculate a patient's individualized risk of finding high-grade prostate cancer (Gleason score 7 or higher) if a prostate biopsy were performed.

The 4Kscore® Test should be utilized in men after an abnormal PSA and/or DRE suspicious of prostate cancer.

The 4Kscore® Test does not provide a diagnosis of prostate cancer. Rather, it is an assessment of a patient's personalized risk for aggressive prostate cancer. 4Kscore® is designed to help clarify the decision on whether or not to perform a prostate biopsy.

 

The 4Kscore® Test algorithm has been researched extensively by scientists at leading international cancer research centers. The accuracy and reliability of the 4Kscore® Test have been shown in clinical trials involving more than 20,000 men.

  • The 4Kscore® Test was validated in two large independent US based prospective studies.
    • When the risk score of 7.5% was used for assessment, no Gleason >8 were missed.
    • One validation study was completed in 2017 and performed at Veterans Health Administration facilities involving a predominantly African American population.
  • Over a dozen peer-reviewed studies on the clinical effectiveness of the 4Kscore® Test have been published.
  • Over 200,000 4Kscore® Tests have been performed in the US.
  • Research has demonstrated that 4Kscore® can risk-stratify men for prostate cancer metastasis and mortality for up to 20 years.

4Kscore Research

The 4Kscore® Test provides an assessment of a patient's risk for aggressive prostate cancer (Gleason 7 or higher) if a prostate biopsy were performed. Patients with an elevated 4Kscore® result should be considered for further evaluation and treatment.

 The 4Kscore® Test result should be interpreted in conjunction with other patient-specific information to develop a personal patient management plan.

4Kscore® Test is not indicated in men with:

  • Previous diagnosis of prostate cancer
  • Digital rectal exam (DRE) performed in the previous 96 hours before phlebotomy
  • 5-alpha reductase medication within previous 6 months
  • Prostate procedure within the last 6 months

The 4Kscore® Test result is usually provided within 2 to 3 working days of receiving a completed requisition and patient sample. For turnaround time on other tests, please contact our Customer Service team at 1-800-627-1479.

The 4Kscore® Test result can be received in the manner most compatible for the physician’s needs. Results can be reported through:

  • Courier delivery
  • Office fax
  • Online reporting through InsightDx
  • Direct interfacing into Electronic Medical Records (EMR)

There is also an easy-to-understand patient report that physicians can use to explain 4Kscore® Test results.

When you are better able to navigate test results and can effortlessly sort through complex sets of patient data, you are free to focus on providing excellent patient care.

Our bio-portal adds value to your EMR investment. It provides an internet-based order entry and results reporting solution for laboratory, pathology, and radiology outreach businesses. Its EMR and EHR connectivity solutions can deliver results to and accept orders from virtually every electronic medical record system in the market today, and more than 30,000 physicians use our system daily for Computerized Physician Order Entry (CPOE) and clinical results review.

Contact your local sales representative for additional details and information.

Yes, physicians nationwide can order 4Kscore®. It is performed using a patient’s blood sample drawn at the physician’s office or a local blood draw facility. The test is performed by BioReference Laboratories, Inc., and results are sent back to the ordering physician.

The 4Kscore® Test is performed by BioReference Laboratories, Inc. (wholly owned subsidiary of OPKO Health, Inc.), a CLIA-Certified and CAP-Accredited laboratory.

If you are interested in adding the 4Kscore® Test to your diagnostic offering, please contact us to request a visit to your office by one of our sales representatives to discuss your service needs. Your dedicated sales representative will also be pleased to provide you with:

  • An overview of our general diagnostic and urology offerings
  • Information on GeneDx, Inc., our genomic laboratory providing a comprehensive genetic testing menu
  • Arrangements for a customized laboratory program
  • Monthly “Clinical Updates” newsletters

Please contact us at 833-4Kscore (833-457-2673) to request a visit to your office by one of our sales representatives to discuss your service needs.

4Kscore® helps you optimize your treatment workflow so that high-risk patients get the diagnosis and treatment they need, while reducing prostate biopsies in men not likely to have aggressive prostate cancer.

BioReference Laboratories, Inc. has contracts with all national carriers and hundreds of regional carriers to simplify billing and minimize out-of-network billing issues. To provide better service, our laboratory helps patients with any insurance questions and makes appeals on patients’ behalf.

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The invoice a patient receives is for laboratory services provided by BioReference, which were ordered by a physician. This invoice is for laboratory testing fees only and is separate from any bill they may have received from the physician and/or paid at the physician’s office. The bill typically includes charges for deductibles, insurance co-payments, or those services not covered by the insurance provider. Please review the insurance policy for more information about specific coverage. If it appears that a patient does not have insurance coverage, or if the information provided to BioReference was incomplete or inaccurate, we will request that the patient provide additional information. We will gladly resubmit any claim to the insurer once we have the new information. Because we work through the patient’s insurance provider in this way, it may take several months after the date of service before a patient receives our bill.

Each time we bill an insurer for laboratory services provided on behalf of the patient or a covered dependent, the insurer will send the patient an Explanation of Benefits. The Explanation of Benefits explains how much the insurer will pay, along with an estimate of the patient’s financial responsibility. Since the Explanation of Benefits is not a bill, the patient should only pay BioReference when they receive a bill directly from us.

If a patient has any  questions  or  concerns,  please  call  our  special  4Kscore®  Customer Service Hotline at 855-4KBILLING (855-452-4554) 9 am - 9 pm EST Monday-Friday.  The BioReference Billing Department can also be reached at 1-800-229-5227, option 2, between the hours of 8 am - 9 pm EST, Monday through Friday.

 

OPKO Health, Inc. is a diverse health care company with the flexibility to adapt to evolving patient needs. OPKO Health, Inc. offers first-in-class products such as Rayaldee® and the 4Kscore® Test, as well as two comprehensive diagnostics divisions: BioReference Laboratories, Inc. and GeneDx, Inc. In addition to clinical products and diagnostics, OPKO Health, Inc. also features a robust research and development pipeline and a variety of biomedical and pharmaceutical business solutions.

For more information, visit http://www.opko.com

References

1. American Cancer Society. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html

2. Parekh 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(3):464-470.

3. Punnen et al. A multi-institutional prospective trial confirms noninvasive blood test maintains predictive value in African American men. J Urol. 2018;199(6);1459-1463.

4. Stattin 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. Eur Urol. 2015;68(2):207-213.

5. Sjoberg et al. Twenty-year risk of prostate cancer death by midlife prostate-specific antigen and a panel of four kallikrein markers in a large population-based cohort of healthy men. Eur Urol. 2018;73(6):941-948